Under the final rule, FDA may assert that an article is subject to regulation as a drug or medical device even if no medical or therapeutic claims are made for it. The final rule abandons the general principle that intended use means “objective intent” as “determined by” the manufacturer’s “expressions.” Under the revised provision, objective intent “may be shown” by such expressions. As a result, the promotional claims of the manufacturer are no longer the linchpin of intended use determinations. As FDA itself explains in the final rule, promotional claims are not required, and the agency “may look to any relevant source of evidence, including a variety of direct and circumstantial evidence,” to determine a product’s intended use.1 According to FDA, these sources may include the following:
- “expressions,” such as “labeling claims, advertising matter, or oral or written statements”
- product “design or composition”
- “the circumstances surrounding ... distribution”
- the circumstance that a manufacturer knew that its product was being “offered or used for a purpose for which it is neither labeled nor advertised”
- “evidence of a manufacturer’s marketing plans”
- “evidence of a manufacturer’s ... directions to its sales force”
- “evidence of the well-known uses and abuses” of the manufacturer’s product
- “circumstantial evidence relating to the sale and distribution of the product”
- evidence that a product “contain[s] a pharmacological ingredient”
- “internal firm documents and circumstances surrounding the sale of products”
- “consumer intent”
- “evidence of claims that were never communicated to the public”
- the “overall circumstances”
The final rule expands the FDCA drug and device definitions by adding “design or composition” to the regulatory definitions of intended use. Under the amended regulations, the words “intended uses” refer to objective intent, which “may be shown by ... the design or composition of the article ....” The preamble states:
The design and composition of an article are examples of the types of evidence that may be relevant when determining the article’s intended use. For example, FDA may consider the design or composition of a product, which includes product characteristics, when determining whether the product is “intended to affect the structure or any function of the body” and therefore meets the device definition in section 201(h) of the FD&C Act (21 U.S.C. 321(h)). The addition of the phrase “design or composition” to the codified [text] reflects FDA’s longstanding and current policy that these are relevant to intended use.2
FDA explains that this language is necessary to align the codified regulations with the agency’s “current practices.”3 In the past, however, FDA efforts to define “intended use” with reference to product characteristics have been met with resistance, and comments submitted to FDA have also objected to the addition of that language.4
Products containing ingredients that FDA regards as “pharmacological” are subject to regulation as drugs under the amended regulations. FDA explains in the final rule that the agency “may look to any relevant source of evidence, including a variety of direct and circumstantial evidence” to determine an article’s intended use.5 According to FDA, these sources may also include evidence that a product contains an ingredient to which druglike properties could be attributed (e.g., antimicrobial ingredients, other drug active ingredients, or analogues).6 From the agency’s perspective, the presence of such an ingredient is a “design feature” that can support an assertion of intended use under the regulations.
Wearable or wellness products with particular physical features suggestive of a medical use could be regulated as medical devices even if not marketed with medical or therapeutic claims. In the preamble, FDA asserts that an article could be regulated as a medical device based solely on physical features.7 As examples, FDA cites three situations in which the size of the product is evidence of the manufacturer’s intent.8 This kind of analysis could jeopardize the status of consumer products over which FDA has long disclaimed jurisdiction. Many unregulated products share design features with regulated medical devices, such as pulse oximeters used for fitness purposes. Such products traditionally have been regulated only if they make medical claims but now appear to be open to regulation based on their technological features.
FDA reaffirms that clinical trials of conventional foods, dietary supplements, and cosmetics may require an IND. The FDCA definition of intended use is significant because it determines whether an article is within the scope of the drug and medical device definitions of the statute. Typically, a determination that a product has an intended use as a drug or device triggers premarket approval or clearance requirements under the FDCA. In the preamble accompanying the proposed rule, however, FDA “note[s] that intended use is relevant in contexts other than premarket approval and clearance.”9 In particular, “FDA evaluates intended use in determining whether research studies involving human subjects involve the administration of a drug and must be conducted under an investigational new drug application (see 21 CFR part 312).”10 This question was addressed by FDA in a guidance document in 2013 and has remained a source of controversy.11
The final rule has potentially far-reaching effects for many types of products. Consumer products that are positioned as wholly beyond the scope of FDA’s regulatory authority under the FDCA may nevertheless be subject to regulation if they are “intended” for drug or device use as defined in the statutory drug or medical device provisions — and FDA has asserted broad authority to find the requisite intent even in the absence of medical or therapeutic claims. An article that is positioned as a consumer product may be subject to medical product regulation if it contains an ingredient or has a characteristic that FDA believes brings it within the scope of the drug and device provisions, for example. Because FDA can consider a wide range of evidence in making intended use determinations under the final rule, product developers and entities involved in the research or manufacture of products having attributes with potential medical application should reconsider their degree of exposure to FDA regulation.
1 86 Fed. Reg. at 41,386, 41,388 (emphasis added).
2 86 Fed. Reg. at 41,390-91 (emphasis added).
3 Id. at 41,390.
4 FDA, Draft Guidance for Industry and FDA Staff: Regulatory Considerations for Microneedling Devices, 82 Fed. Reg. 43,383 (Sept. 15, 2017) (interpreting intended use to include product design and technological characteristics and features); FDA, Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments, 83 Fed. Reg. 58,574 (Nov. 20, 2018) (stating that whether software is a medical device “may depend upon the software’s functions”). For industry comments objecting to this interpretation, see, e.g., MIWG, Comments on Proposed Partial Delay of Effective Date of “Intended Use” Final Rule, Docket No.
FDA-2015-N-2002-2014 (Feb. 5, 2018); MIWG, Comments on Microneedling Draft Guidance, Docket No.
FDA-2017-D-4792-0006 (Nov. 14, 2017); MIWG, Comments on “Intended Use” Final Rule, Docket No.
FDA-2015-N-2002-2001 (July 18, 2017); MIWG, PhRMA & BIO, Petition to Stay and for Reconsideration, Docket
No. FDA-2015-N-2002-1977 (Feb. 8, 2017).
5 86 Fed. Reg. at 41,388 (emphasis added).
6 The preamble also cites a 1994 case involving a product marketed as “an animal food additive intended to reduce pet odor when ingested.” 86 Fed. Reg. at 41,391 (citing United States v. Undetermined Quantities ... “Pets Smellfree,” 22 F.3d 235 (10th Cir. 1994)). According to FDA, the court relied on expert testimony about the antibacterial effects of a particular ingredient in concluding that the product was a drug under the FDCA. 86 Fed. Reg. at 41,391. FDA also cites prior enforcement actions with respect to products containing ingredients that the agency considered to be drug active ingredients, as examples of “situation[s] where design features have been found relevant to intended use.”
7 See April K. Marrone, et al., US Food and Drug Administration and Off-Label Use of Metal Expandable Biliary Stents within the Peripheral Vasculature — Update, 31 J. Vasc. & Interventional Radiology 4 (Feb. 21, 2020); United States v. Caputo, 517 F.3d 935 (7th Cir. 2008) (sterilizer); United States v. Facteau and Fabian, No. 15-CR-10076-ADB, 2020 WL 5517573 (D. Mass. Sept. 14, 2020), appeal docketed, No. 21-1080 USCA and No. 21-1082 USCA (1st Cir. Feb 3, 2021).
8 The preamble discussion thus recalls FDA’s 2009 position on classifying liquid products as either conventional foods or dietary supplements based merely on product size or packaging. Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-distinguishing-liquid-dietary-supplements-beverages (“Liquid products that suggest through their labeled serving size and/or recommended daily intake (e.g., “Drink up to three 16-ounce bottles per day”) that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States are effectively being represented as conventional foods”).
9 85 Fed. Reg. 59,718, 59,723 n.9 (Sept. 23, 2020) (emphasis added).
11 CDER, CBER & CFSAN, Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND (Sept. 2013). FDA received comments asking for further opportunity to comment on parts of the final guidance addressing IND requirements applicable to studies involving products marketed as cosmetics or foods (including dietary supplements). On February 6, 2014, FDA reopened the comment period on those sections See 79 Fed. Reg. 7,204. FDA thereafter received additional comments and in 2015 granted a partial stay of the guidance document. See 80 Fed. Reg. 66,907 (Oct. 30, 2015).