In fact, the court was quite clear that it was uncertain whether a contrast agent could meet the definition of a device, stating –We note that it is not immediately obvious to us how a contrast agent satisfies the device definition’s requirement that the regulated product be “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory….” 21 U.S.C. § 321(h)(1). [The “instrument clause”] Nor is it altogether settled that [the manufacturer’s product] satisfies the device definition’s mode-of-action clauses.. . Because neither question is part of the administrative decision now under review—the FDA found only that Genus’s products “appear to meet” the device definition .. . and both parties continue to agree that they do—we reserve the question whether [the product] satisfies the device definition’s instrument and mode-of-action clauses.Following the court decision, in an unusual turn of events, FDA initiated an “information request” process to gather feedback from the public at large regarding whether and how to shift the classification of products that have been uniformly regulated as drugs for decades to medical devices. Unlike most actions by FDA, this particular activity was not prompted by public health concerns, and the idea was not embraced by stakeholders—comments made by stakeholders in response to the request raised various legal an

FDA has 45 days to seek panel rehearing and/or rehearing en banc, so we should know more on that front soon. In the meantime, manufacturers who hold approved NDAs for affected products, and those considering submission of applications, may want to think carefully about which pathway might be in their best interest and how best to frame their submissions to the Agency.1 ___ F.3d ____ , 20221 WL 1437211 (D.C. Cir. 2021).2 Federal Food, Drug, and Cosmetic Act (“FD&C Act” or “FDCA”) § 201(g)(1), 21 U.S.C. § 321(g)(1) (defining “drug” in relevant part as including “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals”).3 FD&C Act § 201(h), 21 U.S.C. § 321(h) (defining “device” in relevant part as including “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals,... and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes”).4 FD&C Act § 201(g)(1), 21 U.S.C. § 321(g)(1).

[4] Treating transgenic salmon as a “new animal drug” appears to be an indirect—some would argue, a misdirected—way of regulating GE animals at first blush. That regulatory pathway flows from the statutory structure of the federal Food, Drug and Cosmetic Act of 1938 (FDCA), codified at 21 U.S.C. §321 et seq (as amended). “Food” itself is defined statutorily as articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.

When marketers ascribe curative “healing” powers to food and dietary supplements—i.e., statutorily defined as vitamins, minerals, herbs or other botanical substances, amino acids or combinations or concentrates of these forgoing substances—an unsubstantiated choice of words regarding curative health benefits can instantly transform a food or dietary supplement into a “drug” under the Food, Drug and Cosmetic Act of 1938, as amended.[5] The term “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals” per 21 U.S.C. §321(g)(1)(B). A “drug” generally must undergo expensive randomized, double-blind testing to demonstrate efficacy before the drug can be sold to the public.

21 U.S.C. § 321(g). Similarly, “device” is defined as “an instrument, apparatus, implement … or other similar or related article, including any component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals…” 21 U.S.C. § 321(h).In sum, FDA’s statutory authority to regulate a product as a “drug” or “device” is limited to products that are intended to be used to affect a structure or function of the body or that are intended for use in the cure, mitigation, treatment, or prevention of disease.FDA also has statutory authority to regulate traditional cigarettes and other tobacco products under the FDCA as a result of the Family Smoking Prevention and Tobacco Control Act of 2009 (the “Tobacco Act”), but that authority is more limited than that applicable to drugs and devices. Specifically, FDA may regulate “tobacco products,” which the FDCA defines as “any product made or derived from tobacco that is intended for human consumption.”

FDA explains its position about its regulation of CBD containing products in the letters which is also included on this webpage.FDA has stated that CBD-containing products cannot be sold as Dietary Supplements because they do“not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii).

For starters, Amarin alleges that distributors of the identified Synthetically Produced Omega-3 Products are making literally false statements about their products insofar as their labeling asserts that the products are “dietary supplements”:The definition of “dietary supplement” in the FDCA applies only to products that, among other things, bear or contain one or more of the following “dietary ingredients”: “(A) a vitamin, (B) a mineral, (C) an herb or other botanical, (D) an amino acid, (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).” 21 U.S.C. § 321(ff)(1). Products marketed with ingredients that do not fall within the categories of “dietary ingredients” listed in Section 201(ff)(1) of the FDCA, 21 U.S.C. § 321(ff)(1), cannot be marketed as, or for use in, “dietary supplements.”

Global Life Sciences: US-FDA UpdateOn September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics. Section 201(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 321(i)) defines cosmetics as “articles 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.” The Warning Letter alleges that marketing claims on the company’s website cause the products to be new drugs under section 201(p) (21 U.S.C. § 321(p)) and marketed without prior approval in violation of section 505(a) (21 U.S.C. § 355(a)).

This amendment required the FDA to conduct a retrospective evaluation of the effectiveness of the drug products the FDA had approved as safe between 1938 and 1962 through the new drug approval process. Under the 1938 grandfather clause (see 21 U.S.C. 321(p)(1)), a drug product that was on the market prior to passage of the 1938 Act and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application. Additionally, under the 1962 grandfather clause, the FD&C Act exempts a drug from the effectiveness requirements if its composition and labeling has not changed since 1962 and if, on the day before the 1962 Amendments became effective, it was a) used or sold commercially in the United States, b) not a new drug as defined by the FD&C Act at that time, and c) not covered by an effective application.

The court also contrasted the ’864 patent with, for example, the patents for Narcan (U.S. Patent No. 9,211,253) and the EpiPen (U.S. Patent No. 8,870,827), which “claim all the components of a combination drug product.” Id.Finally, the court rejected Sanofi’s argument that the drive mechanism claimed by the ’864 patent is itself a “drug” under 21 U.S.C. § 321(g)(1). Under this statute, the term “drug” includes, inter alia, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals,” and “articles intended for use as a component of any article specified” in the previous clause.