Ala. Admin. Code r. 80-1-22-.02

Current through Register Vol. 43, No. 1, October 31, 2024

Section 80-1-22-.02 - Labeling Of Foods, Drugs, And Cosmetics

(1) For purposes of this Chapter, the term label, as pertaining to foods, drugs and cosmetics that are sold or offered for sale, includes any legend and descriptive matter or design appearing upon the article or its container, and also includes circulars, pamphlets, and the like which are packed and go with the articles to the purchaser, and such letters, circulars and pamphlets to which reference is made either on the label attached to the package or the package itself.

(2) The label shall bear plainly and conspicuously, without any intervening descriptive matter all the information specifically required by the law and regulations thereunder.

(3) A label in a foreign language shall conform to these rules and shall bear in English, as well as in the foreign language used to describe the article, all the information required by the law.

(4) The label shall be free from any statement, design or device regarding the article or the ingredients or substances contained therein, or quality thereof, or place of origin, which is false or misleading in any particular. The terms design and device include abbreviations, characters, signs, and pictorial matter of any description.

(5) A food, drug or cosmetic product shall not be labeled or branded in such a manner as to deceive or mislead the purchaser. Direct misstatements and indirect misrepresentation regarding the article or its ingredients are prohibited, whether by means of designs, printed testimonials, devices, or artifices in the arrangement, style or dress of the package, or in the arrangement of the printed or pictorial matter in or upon the label or package.

(6) An article containing more than one food product or active medicinal agent is misbranded if named after a single constituent. In the case of drugs, the nomenclature of the United States Pharmacopoeia or National Formulary shall be followed.

(7) The statement of the formula is not required on the label except insofar as may be necessary to prevent adulteration or misbranding.

(8) An article of food or drugs which under the law or regulations requires special labeling must carry such label, not only on the original package, but also on all lots removed for display of the goods or for the convenience of handling.

(9) Retail cartons or other outside containers shall be labeled according to the same regulations as are applied to the bottle, can or other receptacle contained therein.

(10) A food product shall be deemed misbranded if the ingredients (where ingredient declaration is required) are not listed by their common or usual name in descending order of predominance by weight.

(11) A drug in package form shall be deemed misbranded if its label fails to bear the name of the product, together with the quantity of the contents in terms of weight, measure or numerical count, and the name and principal address of the manufacturer or other person responsible for placing the product on the market.

(12) If a food offered for sale purports to be or is represented for special dietary use for human consumption by reason of its use as regulating the intake of protein, fat, carbohydrate, or calories for the purpose of controlling body weight, or for the purpose of dietary management with respect to disease, the label shall bear a statement of:

(a) the percent by weight of protein, fat and available carbohydrate in such food; and

(b) the number of available calories supplied by a specified quantity of such food.

(13) The label of dietary foods shall bear the words FOR DIETARY PURPOSES, or DIETETIC, or words of like import, in letters of a height not less than that of the letters of any other word on the label except the brand, and such word or words shall be marked on the label in juxtaposition with or directly above or below the name of the food.

(14) The portion of the store, display counter, shelving, or other place where dietary foods are displayed or offered for sale shall be clearly and plainly identified by an appropriate sign reading FOR DIETARY PURPOSES or words of similar import.

Author: Charles H. Barnes

Ala. Admin. Code r. 80-1-22-.02

Filed April 19, 1982. Reformatted: Filed March 26, 1985; June 19, 1986.

Statutory Authority:Code of Ala. 1975, §§ 20-1-2, 20-1-57.