2023 District of Columbia Code › Title 48 - Foods and Drugs › Chapter 1 - Adulteration › § 48–103. Definitions — “Adulterated article” defined

§ 48–103. Definitions — “Adulterated article” defined.
An article shall be deemed to be adulterated within the meaning of this chapter:
(1) In the case of drugs: (A) if, when sold under or by a name recognized in the United States Pharmacopoeia, it differs from the standard of strength, quality, or purity laid down in the edition thereof at the time official; (B) if, when sold under or by a name not recognized in the United States Pharmacopoeia, but which is found in the German, French, or English Pharmacopoeia, it differs from the strength, quality, or purity laid down therein; (C) if, when sold as a patented medicine, compounded drug, or mixture, it is not composed of all of the ingredients advertised or printed or written on the bottles, wrappers, or labels of or on or with the patented medicine, compounded drug, or mixture; provided, that if the defendant in any prosecution under this chapter, in respect to the sale of any such patented medicine, compounded drug, or mixture, shall prove to the satisfaction of the court that he had purchased the article in question as the same in nature, substance, and quality as that demanded of him by the purchaser, and with a written warranty to that effect, that he had no reason to believe at the time when he sold it that the article was otherwise, and that he sold it in the same state as when he purchased it, he shall be discharged from the prosecution; provided, further, that an offense shall not be deemed to be committed under this section in the following cases:
(A) Where the order calls for an drug inferior to such standard, or where such difference is made known by being plainly written or printed on the package;
(B) Where the drug is mixed with any matter or ingredient not injurious to health and not intended fraudulently to increase its bulk, weight, or measure or conceal its inferior quality, if at the time such drug is delivered to the purchaser it is made known to him that such drug is so mixed;
(2) In the case of food, if:
(A) It bears or contains any poisonous or deleterious substance which may render it injurious to health; except that, if the poisonous or deleterious substance is not an added substance and the quantity of the poisonous or deleterious substance in the food does not ordinarily render it injurious to health, the food is not adulterated for the purpose of this chapter;
(B) It bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406 of the Federal Food, Drug, and Cosmetic Act, approved June 25, 1938 (52 Stat. 1049; 21 U.S.C. § 346);
(C) It bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408 of the Federal Food, Drug, and Cosmetic Act;
(D) It bears or contains any food additive that is unsafe within the meaning of section 409 of the Federal Food, Drug and Cosmetic Act, or a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512 of the Federal Food, Drug, and Cosmetic Act;
(E) It consists, in whole or in part, of any filthy, putrid, or decomposed substance, or is otherwise unfit for food;
(F) It has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health;
(G) It, in whole or in part, is the product of a diseased animal or of an animal which has died otherwise than by slaughter;
(H) It is in a container that is composed, in whole or in part, of any poisonous or deleterious substance, which may render the contents injurious to health;
(I) It intentionally has been subjected to radiation, unless the radiation was used in conformity with a rule or exemption in effect pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act;
(J) Any valuable constituent has been omitted or abstracted, in whole or in part;
(K) Any substance has been substituted, in whole or in part;
(L) Damage or inferiority has been concealed in any manner;
(M) Any substance has been added, mixed, or packed to increase the food’s bulk or weight, reduce the food’s quality or strength, or make the food appear better or of greater value;
(N) It is, bears, or contains a color additive that is unsafe within the meaning of section 721 of the Federal Food, Drug, and Cosmetic Act;
(O) It is a confectionery:
(i) Within which any nonnutritive object is partially or completely imbedded, except that the confectionery shall not be adulterated for purposes of this chapter if the Secretary of the US Department of Health and Human Services determines, by rule, that the nonnutritive object that is partially or completely imbedded in the confectionery has a practical, functional value to the confectionery that does not render the confectionery injurious or hazardous to health;
(ii) That bears or contains more than 0.5% of alcohol by volume, which is derived solely from flavoring extracts, except that the confectionery shall not be adulterated for purposes of this chapter if the confectionery is introduced, delivered for introduction, received, or held for sale;
(iii) That bears or contains any nonnutritive substance, except that the confectionery shall not be adulterated for purposes of this chapter if the nonnutritive substance is a safe substance that is in or on a confectionery product because the nonnutritive substance serves a practical, functional purpose in the manufacture, packaging, or storage of the confectionery product and use of the nonnutritive substance does not promote deception of the consumer or violate any other provision of this chapter;
(P) It is oleomargarine, margarine, butter, or any of the raw material in oleomargarine, margarine, or butter, which contains or consists, in whole or in part, of any filthy, putrid, or decomposed substance, or if the oleomargarine, margarine, or butter is otherwise unfit for food; or
(Q) It is a dietary supplement or contains a dietary ingredient:
(i) That presents a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling or, if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;
(ii) That is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury;
(iii) That is or contains a dietary ingredient that renders the food adulterated under paragraph (1) of this subsection under the conditions of use recommended or suggested in the labeling of the dietary supplement; or
(iv) That has been prepared, packed, or held under conditions that do not comply with current, good manufacturing practice rules, including rules that require expiration date labeling.
(Feb. 17, 1898, 30 Stat. 246, ch. 25, § 3; June 30, 1906, 34 Stat. 768, ch. 3915; Feb. 27, 1925, 43 Stat. 1006, ch. 358, § 13; May 2, 2002, D.C. Law 14-116, § 2(b), 49 DCR 1945; Mar. 13, 2004, D.C. Law 15-105, § 87, 51 DCR 881.)
Prior Codifications
1981 Ed., § 33-103.
1973 Ed., § 33-103.
Effect of Amendments
D.C. Law 14-116, in par. (1), added “provided, further, than an offense shall not be deemed to be committed under this section in the following cases:” at the end of the paragraph; added pars. (1)(A) and (1)B); and rewrote par. (2).
D.C. Law 15-105, in pars. (1) and (2), validated previously made technical corrections.
Emergency Legislation
For temporary (90 day) amendment of section, see § 2(b) of Food Regulation Emergency Amendment Act of 2001 (D.C. Act 14-128, August 3, 2001, 48 DCR 7939).
For temporary (90 day) amendment of section, see § 2(b) of Food Regulation Legislative Review Emergency Amendment Act of 2001 (D.C. Act 14-147, October 23, 2001, 48 DCR 10183).
Temporary Legislation
For temporary (225 day) amendment of section, see § 2(b) of Food Regulation Temporary Amendment Act of 2001 (D.C. Law 14-55, December 6, 2001, law notification 49 DCR 356).
References in Text
Section 408 of the Federal Food, Drug, and Cosmetic Act, referred to in par. (2)(B), is Act June 25, 1938, 52 Stat. 1040, ch. 675, § 408, which is classified to 21 U.S.C. § 346a.
Section 409 of the Federal Food, Drug, and Cosmetic Act, referred to in pars. (2)(D) and (2)(I), is Act June 25, 1938, 52 Stat. 1040, ch. 675, § 409, which is classified to 21 U.S.C. § 348.
Section 512 of the Federal Food, Drug, and Cosmetic Act, referred to in par. (2)(D), is Act June 25, 1938, 52 Stat. 1040, ch. 675, § 512, which is classified to 21 U.S.C. § 360b.
Section 721 of the Federal Food, Drug, and Cosmetic Act, referred to in subsec. (b)(14), is Act June 25, 1938, 52 Stat. 1040, ch. 675, § 721, which is classified to 21 U.S.C. § 379e.