This chapter may be cited as the Alaska Food, Drug, and Cosmetic Act.
Repealed or Renumbered
An advertisement of a food, drug, device, or cosmetic is false if it is false or misleading in any particular.
Repealed or Renumbered
Hearings authorized or required by this chapter shall be conducted under the provisions of AS 44.62 (Administrative Procedure Act).
The Department of Environmental Conservation and the Department of Health and Social Services may adopt regulations for the efficient enforcement of their respective portions of this chapter. Each department may make the regulations conform, in so far as practicable, with those adopted under the federal act.
In AS 17.20.140 - 17.20.155, 'department' means the Department of Environmental Conservation.
Article 05. FALSE ADVERTISING
No person may label or offer for sale any food fish product designated as halibut, with or without additional descriptive words, unless the food fish product is Hippoglossus or Hippoglossus Stenolepsis. A person who violates this section is guilty of misbranding food under provisions of this chapter.
The commissioner of environmental conservation and the commissioner of health and social services may apply to the superior court for, and the court has jurisdiction to grant, a temporary or permanent injunction restraining a person from violating their respective portions of this chapter.
Article 07. PROHIBITED ACTS, PENALTIES, AND LIABILITIES
An officer or employee designated by the commissioner shall have access to a factory, aquatic farm, or establishment, the operator of which holds a permit from the commissioner, for the purpose of ascertaining whether the conditions of the permit are being complied with. Denial of access for inspection is ground for suspension of the permit until access is freely given.
The commissioner is responsible for enforcing AS 17.20.080 - 17.20.135, and may delegate that authority as appropriate. This section does not limit the authority of peace officers.
The commissioner is responsible for enforcing AS 17.20.005 - 17.20.075, and may delegate that authority as appropriate. This section does not limit the authority of peace officers.
The commissioner is responsible for enforcing AS 17.20.160 - 17.20.175, and may delegate that authority as appropriate. This section does not limit the authority of peace officers.
The provisions of this chapter regarding the sale of food, drugs, devices, or cosmetics include the manufacture, production, processing, packing, exposure, offer, possession, and holding of them for sale; the sale, dispensing, and giving of them, and the supplying or applying of them in the conduct of a food, drug, or cosmetic establishment.
The commissioner of environmental conservation is responsible for enforcing AS 17.20.140 - 17.20.155, and may delegate that authority as appropriate. This section does not limit the authority of peace officers.
AS 17.20.110 does not apply to a drug
(1) intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs if the drug is plainly labeled 'for investigational use only'; or
(2) regulated under 42 U.S.C. 262.
(1) 'commissioner' means the commissioner of health and social services;
(2) 'department' means the Department of Health and Social Services.
Article 06. ENFORCEMENT
The commissioner may conduct studies, research, experiments, and demonstrations, directly or through grants to or contracts with public or private agencies, organizations, or individuals to
(1) improve sanitation practices in the processing of fish and fisheries products; and
(2) develop improved techniques for surveillance and inspection activities under this chapter.
(1) 'commissioner' means the commissioner of health and social services;
(2) 'department' means the Department of Health and Social Services.
Article 04. COSMETICS
The attorney general, to whom the commissioner of environmental conservation or the commissioner of health and social services, as the case may be, reports a violation of this chapter, shall institute appropriate proceedings in the superior court without delay and prosecute them in the manner required by law.
(1) 'commissioner' means the commissioner of environmental conservation;
(2) 'department' means the Department of Environmental Conservation.
Article 03. DRUGS AND DEVICES
Nothing in this chapter requires either the commissioner of environmental conservation or the commissioner of health and social services, as the case may be, to report minor violations of their respective portions of this chapter for prosecution, or for the institution of libel or injunction proceedings, when that commissioner believes that the public interest will be adequately served by a suitable written notice or warning.
If the superior court finds that a detained or embargoed article is adulterated or misbranded, it shall, after entry of the decree, be destroyed at the expense of the claimant, under the supervision of the commissioner of environmental conservation or the commissioner of health and social services, as the case may be. Court costs and fees and storage and other proper expenses shall be taxed against the claimant of the article.
Meat, seafood, poultry, vegetable, fruit, or other perishable article in any room, building, vehicle of transportation, or other structure which is unsound, or contains filthy, decomposed, or putrid substance, or a substance that may be poisonous or deleterious to health or otherwise unsafe, is a nuisance. Whenever the commissioner of environmental conservation finds such an article, the commissioner shall immediately condemn or destroy it or in any other manner render it unsalable as human food.
In addition to the enforcement powers, penalties, and remedies available under this chapter, the enforcement powers, penalties, and remedies under AS 45.50.471 - 45.50.561 may be used, where appropriate, to enforce this chapter.
When an article detained or embargoed under AS 17.20.230 has been found by the commissioner of environmental conservation or the commissioner of health and social services, as the case may be, to be adulterated or misbranded, the appropriate commissioner shall petition the superior court for a libel for condemnation of the article. When that commissioner finds that a detained or embargoed article is not adulterated or misbranded, the commissioner shall remove the tag or other marking.
The application provided for in AS 17.20.110 is effective on the 60th day after the filing of it. If the commissioner finds, after notice to the applicant and providing an opportunity for a hearing, that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling, the commissioner shall, before the effective date of the application, issue an order refusing to permit the application to become effective. An order refusing an application to become effective may be revoked by the commissioner.
The commissioner may suspend immediately upon notice a permit issued under AS 17.20.050 if it is found that the conditions of the permit have been violated. The holder of a suspended permit may apply for the reinstatement of the permit, and the commissioner, immediately after prompt hearing and an inspection of the establishment, shall reinstate the permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit as originally issued or as amended.
(a) Meat, fish, or poultry that has been frozen may not be sold, represented, or advertised as a fresh food.
(b) Meat, fish, and poultry that has been frozen must be labeled as a frozen food in accordance with regulations adopted by the commissioner.
(c) The commissioner shall adopt regulations that
(1) require frozen food labels for meat, fish, and poultry that has been frozen; and
(2) provide for the examination and inspection of meat, fish, and poultry to ascertain whether it has been frozen.
A drug sold on a written prescription signed by a member of the medical, dental, or veterinary profession, except a drug sold in the course of the conduct of a business of selling drugs pursuant to diagnosis by mail, is exempt from the requirements of AS 17.20.090 (2) and (5) if (1) the member of the medical, dental, or veterinary profession is licensed by law to administer the drug, and (2) the drug bears a label containing the name and place of business of the seller, the serial number and date of the prescription, and the name of the member of the medical, dental, or veterinary profession.
If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, in determining whether the labeling or advertisement is misleading, there shall be taken into account among other things representations made or suggested by statement, word, design, device, sound, or combination of them, and the extent to which the labeling or advertisement fails to reveal facts material in the light of the representations or material with respect to consequences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement or under customary or usual conditions of use.
When the adulteration or misbranding can be corrected by proper labeling or processing of the article, and after entry of the decree and after costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that the article will be properly labeled or processed has been executed, the court may order that the article be delivered to the claimant for labeling or processing under the supervision of the commissioner of environmental conservation or the commissioner of health and social services, as the case may be. The claimant shall pay the expense of supervision. The bond shall be returned to the claimant of the article on representation to the court by the appropriate commissioner that the article is no longer in violation of this chapter, and that the expenses of supervision have been paid.
(a) In addition to any other penalties imposed under this chapter or AS 45.50.471 - 45.50.561, the department may impose a civil fine on a person for a serious violation or a repeat violation of this chapter, including the regulations adopted under this chapter.
(b) The department shall, by regulation, adopt a schedule of fines that a person may be required to pay under this section. A fine may not exceed $1,000 for each violation.
(c) In this section, 'department' means the Department of Environmental Conservation.
A person who with criminal negligence violates a provision of this chapter or a regulation, order, quarantine, embargo, or recall made under authority of this chapter, or violates a provision of a permit issued under this chapter, is guilty of a class A misdemeanor for each offense. The use of this section for a violation does not prevent imposition of a penalty under AS 45.50.471 - 45.50.561 for the same violation. In this section, 'criminal negligence' has the meaning given in AS 11.81.900 .
When, in the judgment of the commissioner, honest and fair dealing in the interest of consumers will be promoted, the department shall adopt regulations fixing and establishing for food or class of food a reasonable definition and standard of identity, a reasonable standard of quality, and reasonable standards of fill of container. In prescribing a definition and standard of identity for food or class of food in which optional ingredients are permitted, the department shall, for the purpose of promoting honesty and fair dealing in the interest of consumers, designate the optional ingredients which shall be named on the label. The definitions and standards adopted shall conform as far as practicable to the definitions and standards adopted under authority of the federal act. The department shall establish a mobile canned food inspection service available upon request to food packers or processors inside the state.
(a) Whenever the commissioner of environmental conservation finds or has probable cause to believe that a food or cosmetic is adulterated, or so misbranded as to be dangerous or fraudulent within the meaning of this chapter, the commissioner shall affix to it a tag or other appropriate marking, giving notice that it is or is suspected of being adulterated or misbranded and has been detained or embargoed, and warning all persons not to remove or dispose of it by sale or otherwise until permission for removal or disposal is given by the commissioner or the court. A person may not remove or dispose of a detained or embargoed article by sale or otherwise without this permission.
(b) The commissioner of health and social services has the same duty with respect to drugs and devices as the commissioner of environmental conservation has with respect to food and cosmetics under (a) of this section.
When the department finds after investigation that the distribution in the state of a class of food may, by reason of contamination with microorganisms during the manufacture, processing, or packing, be injurious to health, and that the injurious nature cannot be adequately determined after the articles have entered commerce, it, in that case only, shall adopt regulations providing for the issuance of permits to manufacturers, processors, or packers of that class of food, to which shall be attached the conditions governing the manufacture, processing, or packing of that class of food, for a temporary period of time as may be necessary to protect the public health. After the effective date of the regulations, and during the temporary period, no person may introduce or deliver for introduction into commerce the food so manufactured, processed, or packed by any manufacturer, processor, or packer unless the manufacturer, processor, or packer of it holds a permit issued by the commissioner.
A person is not subject to the penalties of AS 17.20.305 , 17.20.315, or AS 45.50.471 - 45.50.561 for having violated AS 17.20.290 (a)(1) or (3) if that person establishes a guaranty or undertaking signed by and containing the name and address of the person residing in the state from whom the article was received in good faith, to the effect that it is not adulterated or misbranded within the meaning of this chapter.
A cosmetic is misbranded if
(1) its labeling is false or misleading in any particular;
(2) it is in package form unless it bears a label containing (A) the name and place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under (B) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations adopted by the department;
(3) a word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed on it with conspicuousness as compared with other words, statements, designs, or devices, in the labeling, and in terms which make it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4) its container is made, formed, or filled so as to be misleading.
In AS 17.20.345 and 17.20.346,
(1) 'donor' includes a person, farmer, retailer, slaughterhouse under state supervision, freight company, distributor, wholesaler, meat processor, seafood processor, or similar entity, and a person who acts in a commercial capacity as a manufacturer, packer, processor, bottler, or similar entity, even if that activity is the person's primary activity;
(2) 'food bank' means a nonprofit organization that operates principally to collect, inspect, and salvage donated food for free distribution either to needy persons or to nonprofit organizations for free distribution to needy persons; in this paragraph, 'nonprofit organization' means an organization recognized by the state or federal government as a nonprofit organization.
(a) The commissioner of environmental conservation and the commissioner of health and social services may have published from time to time reports summarizing judgments, decrees, and court orders which have been rendered under their respective portions of this chapter, including the nature of the charge and the disposition of it.
(b) The commissioner of environmental conservation may have disseminated information regarding food and cosmetics which the commissioner considers necessary in the interest of public health and the protection of the consumer against fraud. This section does not prohibit the commissioner from collecting, reporting, and illustrating the results of the commissioner's investigations.
(c) The commissioner of health and social services has the same power with respect to drugs and devices as the commissioner of environmental conservation has with respect to food and cosmetics under (b) of this section.
(a) In preparing a drug prescription a pharmacist shall indicate on the drug container the name and strength of the drug contained in it, unless specifically directed otherwise by the prescribing physician, osteopathic physician, dentist, or veterinarian. If a drug is a mixture of pharmacologically active substances, only the name of the mixture need be indicated on the container, or in the absence of a name, the term 'physician's mixture' may be used.
(b) In preparing a prescription, a pharmacist may not substitute a drug for a registered brand or trade name product specified unless the pharmacist obtains permission from the author of the prescription; but if the prescribing physician, osteopathic physician, dentist, or veterinarian is temporarily unavailable, the pharmacist may, if unable to supply the drug requested, substitute a drug or preparation of approximately equal therapeutic value so long as the pharmacist notifies the author of the prescription at an early opportunity.
A person may not sell, deliver, offer for sale, hold for sale, or give away a new drug unless
(1) an application for it has become effective under the federal act; or
(2) when not subject to the federal act unless the drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling of it, and before selling or offering it for sale there has been filed with the commissioner an application setting out
(A) full reports of investigations which have been made to show whether or not the drug is safe for use;
(B) a full list of the articles used as components of the drug;
(C) a full statement of the composition of the drug;
(D) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of the drug;
(E) samples of the drug and articles used as components of it which the commissioner requires; and
(F) specimens of the labeling proposed to be used for the drug.
(a) A person may not operate a seafood processing establishment or seafood processing vessel without a seafood processing permit issued by the department. A seafood processing permit issued under this section must be renewed annually.
(b) A person may not operate a seafood processing establishment or a seafood processing vessel without a written hazard analysis critical control point plan that explains the procedures used at each critical control point in the operation of the seafood processing establishment or the seafood processing vessel. The department may review, and comment on, the completeness of the hazard analysis critical control point plan prepared for a seafood processing establishment or a seafood processing vessel; however, the department may not require annual submission of the plan unless a change in operation, product, or process necessitates a change in the plan. In this subsection, 'critical control point' means a point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.
The publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, is not liable under AS 17.20.305 , 17.20.315, or AS 45.50.471 - 45.50.561 for the dissemination of the false advertisement, unless the publisher, licensee, agency or medium has refused the request of the commissioner of health and social services to furnish the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency, residing in the state who caused dissemination of the advertisement.
Article 08. GENERAL PROVISIONS
(a) The commissioner of environmental conservation or an agent shall have free access at reasonable hours to a factory, warehouse, or establishment in which foods or cosmetics are manufactured, processed, packed, or held for introduction into commerce, to enter a vehicle being used to transport or hold these foods or cosmetics in commerce, or to an aquatic farm in order to
(1) inspect a factory, warehouse, establishment, vehicle, or aquatic farm to determine if the provisions of the commissioner's respective portions of this chapter are being violated; and
(2) secure samples or specimens of a food, aquatic farm product, or cosmetic.
(b) The commissioner of environmental conservation shall make or have made examinations of samples secured under this section to determine whether or not a provision of the commissioner's respective portions of this chapter is being violated.
(c) The commissioner of health and social services has the same powers and duties with respect to drugs and devices as the commissioner of environmental conservation has with respect to food and cosmetics under (a) and (b) of this section.
A poisonous or deleterious substance added to food, except where the substance is required in the production of food or cannot be avoided by good manufacturing practice, is unsafe for purposes of the application of AS 17.20.020 (a)(2). When the substance is required or cannot be avoided, the department shall adopt regulations limiting the quantity of it to the extent necessary for the protection of public health. A quantity exceeding the limits fixed is unsafe for purposes of the application of AS 17.20.020 (a)(2). While a regulation limiting the quantity of a substance in the case of any food is in effect, the food is not, by reason of bearing or containing an added amount of the substance, adulterated within the meaning of AS 17.20.020 (a)(1). In determining the quantity of the added substance to be tolerated in or on food, the department shall consider the extent to which the use of the substance is required or cannot be avoided in the production of each article and the other ways in which the consumer may be affected by that or other poisonous or deleterious substances.
A cosmetic is adulterated if
(1) it bears or contains a poisonous or deleterious substance which may render it injurious to a user under the conditions of use prescribed in the labeling or advertisement of it, or under conditions of use which are customary or usual; however, this provision does not apply to coal tar hair dye, the label of which bears the following legend conspicuously displayed: 'Caution - this product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.' and the labeling of which bears adequate directions for preliminary testing, and for the purposes of this paragraph and (5) of this section the term 'hair dye' does not include eyelash dyes or eyebrow dyes;
(2) it consists in whole or in part of a filthy, putrid, or decomposed substance;
(3) it has been produced, prepared, packed, or held under insanitary conditions by which it may have become contaminated with filth or made injurious to health;
(4) its container is composed, in whole or in part, of a poisonous or deleterious substance which may make the contents injurious to health;
(5) it is not a hair dye and it bears or contains a coal tar color other than one from a batch which has been certified under authority of the federal act.
The advertisement of a drug or device representing that it has an effect on albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia, or venereal disease is false advertising. An advertisement not in violation of AS 17.20.160 is not false under this section if it is disseminated only to members of the medical, dental, or veterinary profession, or appears only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of the drug or device. However, when the commissioner determines that an advance in medical science has made a self-medication safe as to any of the diseases named in this section, the department shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for the disease, subject to the conditions and restrictions the commissioner considers necessary in the interests of public health. This section shall not be construed as indicating that self-medication for diseases other than those named in this section is safe or efficacious.
(a) A person who sells halibut, salmon, or sablefish products at wholesale or retail in this state may label or advertise the product as being or containing a 'wild' halibut, salmon, or sablefish product, an 'antibiotic-free' halibut, salmon, or sablefish product, or a 'hormone-free' halibut, salmon, or sablefish product, and may indicate that the product or the halibut, salmon, or sablefish in the product is free from added colors and additives, if the product or the halibut, salmon, or sablefish in the product
(1) is harvested from a river or an ocean;
(2) has not been raised in captivity under control for its entire life; and
(3) is free from added colors and additives.
(b) The labeling or advertising allowed for a halibut, salmon, or sablefish product by (a) of this section may appear on the principal display panel of a packaged product, may be conspicuously attached to the container of a bulk product, or may appear in an advertisement for the product, including media advertising and displays or placards posted in retail stores. In this subsection, 'principal display panel' means the part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for sale.
(c) In this section, 'halibut, salmon, or sablefish product' means halibut, salmon, or sablefish, or a product made from halibut, salmon, or sablefish.
(a) The Alaska Seafood Marketing Institute established in AS 16.51 shall design an 'inspection' seal that may be used to signify that a seafood product has been packed in compliance with the requirements of a permit issued under AS 17.20.065 .
(b) The Alaska Seafood Marketing Institute shall design a 'premium quality' seal that may be used to signify that a seafood product has met the product specifications and standards under (d) of this section.
(c) The commissioner shall authorize the use of an 'inspection' seal for display on seafood products processed by a person who, at the time the products are processed, holds a permit to operate issued under AS 17.20.065 and who complies with regulations adopted under this chapter.
(d) The commissioner, after consultation with the Alaska Seafood Marketing Institute, shall develop product specifications and standards for the use of the 'premium quality' seal on Alaska seafood products. The commissioner shall authorize a seafood processor to display a 'premium quality' seal on products that qualify for the seal if the processor meets the requirements of regulations adopted under this chapter and has been issued a permit to operate under AS 17.20.065 .
(e) A person may not display a seal under this section without authorization from the commissioner.
(a) Notwithstanding the provisions of AS 17.20.290 , 17.20.305, or 17.20.315, a food bank that receives and distributes food is not subject to civil or criminal liability arising from an injury or death attributable to the condition of the food if
(1) the food bank inspects the food received in a reasonable manner and finds it to be apparently fit for human consumption at the time of distribution;
(2) the food bank has no actual or constructive knowledge at the time the food is distributed that it is adulterated, tainted, contaminated, or would be harmful to the health or well-being of an individual consuming it; and
(3) the injury or death is not a direct result of the negligence, recklessness, or intentional misconduct of the food bank.
(b) Nothing in this section, AS 17.20.290 , 17.20.305, 17.20.315, or AS 45.50.471 - 45.50.561 prohibits the distribution by a food bank of food apparently fit for human consumption at the time of its distribution solely because
(1) the label on the food is missing or the food is otherwise misbranded; or
(2) the food, if sold commercially, would not be readily marketable because of appearance or grade, or because it is surplus.
(a) A drug or device is adulterated if
(1) it consists in whole or in part of a filthy, putrid, or decomposed substance;
(2) it has been produced, prepared, packed, or held under insanitary conditions in which it may have been contaminated with filth, or in which it may have been rendered injurious to health;
(3) it is a drug and its container is composed, in whole or in part, of poisonous or deleterious substance which may render the contents injurious to health; or
(4) it is a drug and it bears or contains, for purposes of coloring only, a coal tar other than one from a batch certified under the authority of the federal act.
(b) A drug is adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below the standard set forth in the compendium. The determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendium, or in the absence or inadequacy of tests or methods of assay, those prescribed under authority of the federal act. A drug defined in an official compendium is not adulterated under this subsection because it differs from the standard of strength, quality, or purity set forth in the compendium, if its difference in strength, quality, or purity is plainly stated on its label. When a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States it is subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homeopathic drug, in which case it is subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.
(c) A drug is adulterated if it is not subject to the provisions of (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
(d) A drug is adulterated if a substance has been
(1) mixed or packed with it to reduce its quality or strength; or
(2) substituted wholly or in part for it.
(a) Notwithstanding AS 17.20.048 , a retail food establishment shall state on the menu of prepared food products that it is selling whether the fish in a prepared food product is wild fish or farmed fish.
(b) In this section,
(1) 'farmed fish' means fish that is propagated, farmed, or cultivated in a facility that grows, farms, or cultivates the fish in captivity or under positive control but that is not a salmon hatchery that is owned by the state or that holds a salmon hatchery permit under AS 16.10.400 ; in this paragraph, 'positive control' has the meaning given in AS 16.40.199 ;
(2) 'fish' means finfish;
(3) 'prepared food product' means a food product that has been prepared by the retail food establishment selling the food product or by another person at the direction of the retail food establishment;
(4) 'retail food establishment' means a business that sells prepared food products to the general public for consumption on or off the premises, and includes a business that is, or contains on its premises, a restaurant, a delicatessen, a salad bar, or a bakery; 'retail food establishment' does not include an establishment that is provided by
(A) an employer primarily for the employees of the employer;
(B) a school primarily for the students and employees of the school; or
(C) a correctional facility primarily for persons held under official detention;
(5) 'wild fish' means a fish that
(A) is harvested from a river, a lake, or an ocean;
(B) has not been raised in captivity under control for its entire life; and
(C) is free from added colors and additives.
(a) Notwithstanding the provisions of AS 17.20.290 , 17.20.305, or 17.20.315, a donor of food for free distribution by a food bank is not subject to civil or criminal liability arising from an injury or death attributable to the condition of the donated food if the injury or death is not a result of the gross negligence, recklessness, or intentional misconduct of the donor.
(b) Nothing in this section, AS 17.20.290 , 17.20.305, 17.20.315, or AS 45.50.471 - 45.50.561 prohibits the donation by a donor of food apparently fit for human consumption at the time of its donation solely because
(1) the label on the food is missing or the food is otherwise misbranded; or
(2) the food, if offered for sale commercially, would not be readily marketable because of appearance or grade, or because it is surplus.
(c) A person who donates to a food bank salmon from a hatchery that operates under a permit issued under AS 16.10.400 - 16.10.470 is immune from liability as provided in this section if the salmon is apparently fit for human consumption at the time of its donation, even if the hatchery does not have a permit issued by the Department of Environmental Conservation under this chapter or other statute to process fisheries products for human consumption.
(a) Food is adulterated if
(1) it bears or contains a poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance the food is not considered adulterated under this paragraph if the quantity of the substance does not ordinarily render it injurious to health;
(2) it bears or contains added poisonous or added deleterious substance which is unsafe within the meaning of AS 17.20.030 ;
(3) it consists in whole or in part of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;
(4) it has been produced, prepared, packed, or held under insanitary conditions in which it may have become contaminated with filth, or in which it may have been rendered diseased, unwholesome, or injurious to health;
(5) it is, in whole or in part, the product of a diseased animal or an animal which has died otherwise than by slaughter, or that has been fed upon the uncooked offal from a slaughterhouse;
(6) its container is composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.
(b) Food is adulterated if
(1) a valuable constituent has been omitted or abstracted in whole or part;
(2) a substance has been substituted in whole or part for a valuable constituent;
(3) damage or inferiority has been concealed;
(4) a substance has been added or mixed or packed with it to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
(c) Confectionery is adulterated if it bears or contains an alcohol or nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one percent, harmless natural wax not in excess of four-tenths of one percent, harmless natural gum, and pectin. This subsection does not apply to confectionery containing less than one-half of one percent by volume of alcohol derived solely from the use of flavoring extracts, or to chewing gum containing harmless nonnutritive masticatory substances.
(d) Food is adulterated if it bears or contains a coal tar color other than one from a batch which has been certified under authority of the federal act.
To carry out the requirements of this chapter, the commissioner may issue orders, regulations, permits, quarantines, and embargoes relating to
(1) food offered to the public or sold, including
(A) inspection of meat, fish, poultry, and other food products;
(B) standards of sanitation and handling methods for all phases of slaughtering, processing, storing, transporting, displaying, and selling;
(C) labeling; and
(D) the training, testing, and certification requirements for individuals who handle or prepare food, their supervisors, and their employers to ensure their knowledge of food safety and sanitation principles and requirements;
(2) control and eradication of pests;
(3) enforcement of hazard analysis critical control point programs for seafood processing that are developed in cooperation with appropriate industry representatives or, to the extent not inconsistent with this chapter or regulations adopted under the authority of this chapter, that are established by regulations of the United States Food and Drug Administration as they may periodically be revised;
(4) labeling, subject to AS 17.20.013 , and grading of milk and milk products and standards of sanitation for dairies offering to the public or selling milk or milk products to at least the minimum of current recommendations of the United States Public Health Service pasteurized milk ordinance as it may periodically be revised;
(5) standards and conditions for the operation and siting of aquatic farms and related hatcheries, including
(A) restrictions on the use of chemicals; and
(B) requirements to protect the public from contaminated aquatic farm products that pose a risk to health;
(6) monitoring aquatic farms and aquatic farm products to ensure compliance with this chapter and, to the extent not inconsistent with this chapter or regulations adopted under the authority of this chapter, with the requirements of the national shellfish sanitation program manual of operations published by the United States Food and Drug Administration as it may periodically be revised;
(7) tests and analyses that may be made and hearings that may be held to determine whether the commissioner will issue a stop order or quarantine;
(8) transportation of, use of, disposal of, recalls of, or warnings concerning quarantined or embargoed items;
(9) cooperation with federal and other state agencies.
Article 02. FOOD AND AQUATIC FARM PRODUCTS
(a) The following acts and the causing thereof are prohibited:
(1) the manufacture, or sale, or delivery, holding, or offering of sale of food, drug, device, or cosmetic that is adulterated or misbranded;
(2) the adulteration or misbranding of food, drug, device, or cosmetic;
(3) the receipt in commerce of food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of them for pay or otherwise;
(4) the sale, delivery for sale, holding for sale, or offering for sale of an article in violation of AS 17.20.050 - 17.20.070 and 17.20.100;
(5) the dissemination of a false advertisement;
(6) the refusal to permit entry or inspection, or to permit the taking of a sample, as authorized by AS 17.20.200 ;
(7) the giving of a guaranty or undertaking which is false, except by a person who relied on a guaranty or undertaking to the same effect signed by and containing the name and address of the person residing in the state from whom the person who relied on the guarantee or undertaking received the food, drug, device, or cosmetic in good faith;
(8) the removal or disposal of a detained or embargoed article in violation of AS 17.20.230 - 17.20.270;
(9) the alteration, mutilation, destruction, obliteration, or removal of the whole or part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if the act is done while the article is held for sale and results in the article being misbranded;
(10) forging, counterfeiting, simulating, or falsely representing, or without proper authority using a mark, stamp, tag, label, or other identification device authorized or required by regulations adopted under AS 17.20.230 - 17.20.270;
(11) the using, on the labeling of a drug or in an advertisement relating to a drug, of a representation or suggestion that an application with respect to the drug is effective under AS 17.20.110 or that the drug complies with the provisions of that section;
(12) the sale or offering for sale of frozen fish as fresh fish;
(13) the improper labeling and drug substitution by pharmacists under AS 17.20.105 .
(b) The commissioner of environmental conservation or a designee of the commissioner is responsible for enforcing the provisions of (a)(1) - (10) of this section, if the subject of the prohibited act involves food or cosmetics, and the provisions of (a)(12) of this section. This subsection does not limit the authority of peace officers.
(c) The commissioner of health and social services or a designee of the commissioner is responsible for enforcing the provisions of (a)(1) - (10) of this section, if the subject of the prohibited act involves drugs or devices, and the provisions of (a)(11) and (13) of this section. This subsection does not limit the authority of peace officers.
In this chapter,
(1) 'advertisement' means a representation disseminated, other than by labeling, for the purpose of inducing, or which is likely to induce directly or indirectly the purchase of food, drugs, devices, or cosmetics;
(2) 'antiseptic', in the labeling or advertisement of a drug, is a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or other use involving prolonged contact with the body;
(3) 'aquatic farm' has the meaning given in AS 16.40.199 ;
(4) 'aquatic farm product' has the meaning given in AS 16.40.199 ;
(5) 'contaminated with filth' means food, drug, device, or cosmetic not securely protected from dust, dirt, and as far as necessary by all reasonable means, from foreign or injurious contamination;
(6) 'cosmetic' means an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, and an article intended for use as a component of an article enumerated in this paragraph; except that the term does not include soap intended for cleansing purposes only;
(7) 'device' except when used in AS 17.20.040 (a)(6), 17.20.090(3), 17.20.150(3), 17.20.290(a)(10) and 17.20.300 means an instrument, apparatus, and contrivance, including its components, parts, and accessories, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal; or to affect the structure or function of the body of man or animal;
(8) 'drug' means an article recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary; an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animal; an article other than food, intended to affect the structure or function of the body of man or animal; and an article intended for use as component of an article specified in this paragraph but does not include devices or their components, parts, or accessories;
(9) [Repealed, Sec. 4 ch 8 SLA 2002].
(10) 'federal act' means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 - 392; 52 Stat. 1040 - 1059;
(11) 'fish or fisheries products' means any aquatic animal, including amphibians, or aquatic plants or parts of those plants, animals, or amphibians that are usable as human food.
(12) 'food' means an article used for food or drink for man or animal, chewing gum, and articles used for components of either of them;
(13) 'immediate container' does not include a package liner;
(14) 'label' means a display of written, printed or graphic matter upon the immediate container of an article; however, a requirement made by or under authority of this chapter that a word, statement, or other information appear on the label is not complied with unless the word, statement, or other information also appears on the outside container or wrapper of the retail package, if there is one, or is easily legible through the outside container or wrapper;
(15) 'labeling' means the label and other written, printed, or graphic matter upon an article or its container or wrapper accompanying the article;
(16) 'new drug' means a drug the composition of which is such that it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use under the conditions prescribed, recommended, or suggested in the labeling of it; or a drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in these investigations, been used to a material extent or for a material time under those conditions;
(17) 'official compendium' means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or supplements to them.
A drug or device is misbranded
(1) if its labeling is false or misleading in any particular;
(2) if it is in package form unless it bears a label containing (A) the name and place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under (B) of this paragraph reasonable variations shall be permitted and exemptions for small packages shall be established by regulations adopted by the department;
(3) if a word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed with conspicuousness as compared with other words, statements, designs, or devices, in the labeling and in terms which render it likely to be read and understood by the ordinary individual under customary conditions of the purchase and use;
(4) if it is for use by man and contains a quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulphonmethane, or a chemical derivative of any of them, which has been by the commissioner after investigation found to be and by regulations under this chapter designated as habit forming; unless its label bears the name, and quantity or proportion of the substance or derivative and in juxtaposition with it the statement 'Warning - May be habit forming';
(5) if it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (A) the common or usual name of the drug; and (B) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of alcohol, and including, whether active or not, the name and quantity or proportion of bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis glucosines, mercury, quabain, strophanthin, strychnine, thyroid, or derivative or preparation of any of these substances contained in them; however, to the extent that compliance with the requirements of (B) of this paragraph is impracticable, exemptions shall be established by regulations adopted by the department;
(6) unless its labeling bears (A) adequate directions for use; and (B) adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in the manner and form necessary for the protection of users; however, where a requirement of (A) of this paragraph as applied to a drug or device is not necessary for the protection of the public health, the department shall adopt regulations exempting the drug or device from these requirements;
(7) if it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed in the compendium; however, the method of packing may be modified with the consent of the commissioner, and when a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it is subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States; and not to those of the United States Pharmacopoeia;
(8) if it has been found by the commissioner to be a drug liable to deterioration, unless it is packaged in the form and manner and its label bears a statement of the precautions the department by regulation requires as necessary for the protection of public health; and no regulation shall be established for a drug recognized in an official compendium until the commissioner has informed the appropriate body charged with the revision of the compendium of the need for packaging or labeling requirements and that body has failed within a reasonable time to prescribe the requirements;
(9) if it is a drug and its container is made, formed, or filled so as to be misleading or if it is an imitation of another drug; or if it is offered for sale under the name of another drug;
(10) if it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling;
(11) if (A) it is a drug sold at retail and contains any quantity of aminopyrine, barbituric acid, cincohophen, pituitary, thyroid, or their derivatives, or (B) it is a drug or device sold at retail and its label as originally packed bears a statement that it is to be dispensed or sold only by or on the prescription of a physician, dentist, or veterinarian, unless it is sold on a written prescription signed by a member of the medical, dental, or veterinary profession licensed by law to administer the drug or device, and its label as dispensed bears the name and place of business of the seller, the serial number and date of the prescription, and the name of the member of the medical, dental, or veterinary profession, and the prescription shall not be refilled except on the written authorization of the prescribing physician, dentist, or veterinarian.
(a) Food is misbranded if
(1) its labeling is false or misleading in any particular;
(2) it is offered for sale under the name of another food;
(3) it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word 'imitation' and, immediately thereafter, the name of the food imitated;
(4) its container is made, formed, or filled so as to be misleading;
(5) it is in package form unless it bears a label containing (A) the name and place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under (B) of this paragraph, reasonable variations are permitted, and exemptions for small packages shall be established by regulations prescribed by the department;
(6) a word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed with the conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in terms that make it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(7) it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by AS 17.20.010 , unless (A) it conforms to the definition and standard, and (B) its label bears the name of the food specified in the definition and standard and the common names of optional ingredients other than spices, flavoring, and coloring present in the food as required by regulation;
(8) it purports to be or is represented as (A) a food for which a standard of quality has been prescribed by regulations, and its quality falls below that standard, unless its label bears, in the manner and form the regulations specify, a statement that it falls below that standard; or (B) a food for which a standard of fill of container has been prescribed by regulation as provided by AS 17.20.010 and it falls below the applicable standard of fill of container, unless its label bears, in the manner and form as the regulations specify, a statement that it falls below that standard;
(9) it is not subject to the provisions of (7) of this subsection, unless it bears labeling clearly giving (A) the common or usual name of the food, if any, and (B) in case it is fabricated from two or more ingredients, the common or usual name of each ingredient; except that, however, spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings, without naming each; however, to the extent that compliance with the requirements of (B) of this paragraph is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations adopted by the department, but the requirements of (B) of this paragraph do not apply to food products that are packaged at the direction of purchasers at retail at the time of sale, the ingredients of which are disclosed to the purchasers by other means in accordance with regulations adopted by the department;
(10) it purports to be or is represented for special dietary uses, unless its label bears information concerning its vitamin, mineral, and other dietary properties the commissioner determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for those uses;
(11) it bears or contains artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact; however, to the extent that compliance with the requirements of this paragraph is impracticable, exemption shall be established by regulations adopted by the department;
(12) the food is a farmed halibut, salmon, or sablefish product, unless
(A) the product is labeled to identify the product as farmed fish raised outside the state, if the product is sold in a packaged form; or
(B) the product is conspicuously identified as farmed fish raised outside the state, if the product is sold in an unpackaged form;
(13) the labeling, advertisement, or identification of the food is inconsistent with the labeling, advertisement, or identification provisions of AS 17.20.048 or 17.20.049.
(b) In (a)(12) of this section, 'farmed halibut, salmon, or sablefish product' means a food product that contains halibut, salmon, or sablefish that is propagated, farmed, or cultivated in a facility that grows, farms, or cultivates finfish in captivity or under positive control but that is not a salmon hatchery that is owned by the state or that holds a salmon hatchery permit under AS 16.10.400 ; in this subsection, 'positive control' has the meaning given in AS 16.40.199 .
(a) Products offered for wholesale or retail sale in this state that contain milk, cream, or any product or byproduct of milk or cream and that have been processed and handled under the requirements of this section may be labeled 'Milk in this product is from cows not treated with rBGH' or 'Milk in this product is from cows not treated with rBST.' Labeling of milk products under this section may also include an indication that the milk used is 'farmer certified rBGH-free' or 'farmer certified rBST-free.' If a milk product label contains the rBGH or rBST language allowed under this subsection, the label must also state 'No significant difference has been shown between milk derived from rBST treated and non-rBST treated cows.' Milk products offered for wholesale or retail sale in this state are not required to contain any further label information related to the use of rBGH or rBST in milk products.
(b) The labeling described in (a) of this section may appear on the principal display panel of a packaged milk product, may be conspicuously attached to the container of a bulk product, or may appear in an advertisement for a milk product, including media advertising or displays or placards posted in retail stores. In this subsection,
(1) 'advertisement' means the representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of the milk product;
(2) 'principal display panel' means that part of a label that is most likely to be displayed, presented, shown, or examined under normal and customary conditions of display for sale.
(c) A dairy plant that purchases milk or cream to be used in milk products labeled under (a) of this section shall require an affidavit from producers supplying the milk. The producer or authorized representative of the producer shall sign the affidavit, and the affidavit must state that all cows used in the producer's dairy operations have not and will not be treated with rBGH without advance written notice to the dairy plant of at least 30 days.
(d) The affidavit required under (c) of this section must contain
(1) the name and address of the producer;
(2) the grade A milk permit number of the producer;
(3) the name of the producer's farm and its address if different from the address of the producer;
(4) the telephone number of the producer;
(5) the name of the dairy plant receiving the milk; and
(6) a statement in substantially the following form:
State of Alaska )
) ss:
________ Judicial District )
I, ________________________, as the owner or permit holder responsible
for the dairy farm operation identified above, hereby certify as
follows:
(A) that no animals on the above farm are currently being treated
with recombinant bovine somatotropin (rBST), also known as recombinant
bovine growth hormone (rBGH);
(B) that no animals on the above farm have received rBST treatments
within the past 30 days;
(C) that I will provide written notice to the buyer of my milk at
least thirty (30) days in advance if I intend to use rBST on my dairy
cattle; and
(D) that I will not sell milk from animals added to my herd if
those animals may have received rBST treatment within the previous 30
days.
I declare, under oath, that the above statement is true and correct to
the best of my knowledge.
Producer Signature ________________________
Subscribed and sworn to or affirmed before me at _________ on ______ .
(date)
______________________________ Notary Public
My Commission Expires ________
(e) A dairy plant shall keep the original affidavit provided under (c) of this section on file for a period of not less than two years. The affidavit and corresponding records shall be made available for inspection by the commissioner. If the milk product is to be labeled under (a) of this section, dairy plants supplying milk or cream to a processor or to a manufacturer of a milk product for use in the milk product shall supply the processor or manufacturer with a certificate stating that the producers of the supplied milk or cream have executed and delivered the affidavits as required by (c) of this section.
(f) All milk or cream from non-rBGH-treated cows used in the manufacturing or processing of milk products labeled under (a) of this section, and milk or cream supplied by a producer using an affidavit under (c) of this section, shall be kept completely separate from any other milk or cream throughout all stages of storage, transportation, and processing until the resulting milk products are in final packaged form in a properly labeled container. The dairy plant and the processor or manufacturer at each stage shall keep records of the separation and make them available to the commissioner for inspection.
(g) In this section,
(1) 'milk product' means any product that contains milk, cream, or any product or byproduct of milk or cream;
(2) 'recombinant bovine growth hormone' or 'rBGH' means a growth hormone that is intended for use in bovine animals and that has been produced through recombinant DNA techniques described as 'recombinant bovine somatotropin' or 'rBST.'
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