Does a product's ingredient list decide whether it is a supplement or a drug?

Ingredients can help show intended use, but they do not settle it. In the Nordic Clinical matter, the government argued that a product is a drug not because of its ingredients but because of what it is intended to be used for. It applied that reasoning to Neurocet, arguing that the ingredients were irrelevant to whether the product met the statutory definition of a "dietary supplement" because its objective intended uses included curing, mitigating, treating, or preventing disease.

Does a disclaimer on the label protect a product that is marketed as treating disease?

Not when the distributor's marketing shows the product is meant to treat disease. An ingestible product labeled a "dietary supplement" is a drug if its distributor intends it to cure, mitigate, treat, or prevent disease, even if the labeling also includes disclaimers about that intent.

Can the claims on my website be used to show what my product is intended for?

Yes, when the website is part of how the product is marketed or sold. Information on a company's website from which the product is marketed or sold can constitute "labeling" if it is provided as part of an integrated distribution program with respect to the drug.

Can a scientific article or other third-party publication I distribute count as evidence of my product's intended use?

It can, but the answer turns on facts about how the publication is sold and distributed. In a pretrial brief before the FTC, respondents argued that if a manufacturer's publication is considered labeling, the claims in it may be construed as evidence of the manufacturer's "intended use" of its supplement as an unapproved new drug. In Pearson v. Leavitt, the Fourth Circuit stressed that who sells the publication, how it is marketed, the purpose for which it is used, and how it is distributed are a necessary part of that analysis.

If a disease claim for a food or supplement is true and backed by evidence, is it safe to make?

Not as far as FDA is concerned. As described in a respondents' pretrial brief before the FTC, FDA deems claims that state or imply a food is intended for disease use to be drug claims not permitted for food, even if they are true and substantiated. The FTC asks a different question: whether claims are truthful, non-misleading, and substantiated. In the POM Juice matter, Complaint Counsel took the position that carefully qualified claims conveying a net impression other than that the product is effective for treating, preventing, or reducing the risk of disease need no FDA pre-approval.

Does intended use matter for products outside the drug context?

Yes, the Textile Fiber Products Identification Act regulations use it to set their scope. Textile fiber products intended for uses outside the Act, or intended for use in other textile fiber products that are exempted or excluded, are not subject to the labeling and invoicing requirements, provided an invoice or other document covering the marketing or handling of the products indicates that they are not intended for uses subject to the Act.

HealthLegal test

Intended use

Berkeley Robinson, Managing Attorney at Robinson Law Firm PLLC

Author

Berkeley Robinson, Esq.

Managing Attorney, Robinson Law Firm PLLC

Berkeley has served as the go-to counsel for many scaling businesses in a transactional and litigation management capacity. Before becoming an attorney, Berkeley grew sales teams, ran online marketing campaigns, and did everything else an entrepreneur does—and still does today as the founder of two online businesses.

Definition

"Intended use" is used in more than one setting, and its meaning depends on the context. Under the Federal Food, Drug, and Cosmetic Act, it means the objective intent of the persons legally responsible for the labeling of that article. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 That intent is determined by the responsible persons' own expressions, or it can be shown by the circumstances surrounding distribution, such as labeling claims, advertising, statements by those persons or their representatives, or use for a purpose for which the article was neither labeled nor advertised, when those persons knew of it. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128

Key legal rules

Intended use works less as a stand-alone rule than as a test that decides which regulatory rules apply to a product, so these rules turn on what a seller's marketing shows:

Under the Food, Drug, and Cosmetic Act, "drugs" include articles intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (Exhibit D to Petition To Stay Investigation and Quash Civil Investigative Demands) (discussing 21 U.S.C. §§ 321(g), 331) "Drugs" also include articles other than food that are intended to affect the structure or function of the body of man or other animals. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (Exhibit D to Petition To Stay Investigation and Quash Civil Investigative Demands) (discussing 21 U.S.C. §§ 321(g), 331)
A product that might otherwise meet the definition of a "dietary supplement" is a drug, and is regulated as a drug rather than a dietary supplement, if it meets the drug definition. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (Exhibit D to Petition To Stay Investigation and Quash Civil Investigative Demands) (discussing 21 U.S.C. §§ 321(g), 331) An ingestible product labeled a "dietary supplement" is a drug if its distributor intends it to cure, mitigate, treat, or prevent disease in man, even if the labeling also includes disclaimers about that intent. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128
Material that explains a drug's uses and is provided as part of an integrated distribution program is "labeling," even if it was not physically attached to the drug or shipped with it. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 Information on a company's website from which the product is marketed or sold can constitute "labeling" if it is provided as part of an integrated distribution program with respect to the drug. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128
FDA may look to claims made in advertising as evidence of a company's intended use for its food, because articles are defined by their intended use, as evidenced by marketing claims. Source: Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version] (FTC) Under FDA's approach, claims that state or imply that a food is intended for use in curing, mitigating, treating, or preventing disease are deemed drug claims not permitted for food, even if they are true and substantiated by evidence. Source: Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version] (FTC)
A determination of "intended use" must be grounded in a fact-based inquiry and cannot rest on speculative contentions. Source: Pearson v. Leavitt, 189 F. App'x 161 (4th Cir. 2006)
Once intended use makes a product a new drug, a manufacturer must obtain FDA approval of a new drug application or an abbreviated new drug application before the drug may legally be introduced into interstate commerce. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128

For the sake of space, this page lists only the primary rules related to this term that most businesses should follow. More may apply to your situation, and your unique facts affect how they apply.

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Why these rules exist

Intended use matters because it decides which regulatory category a product falls into. Under the Food, Drug, and Cosmetic Act, the "intended use" of a product is the ultimate key to determining which category it belongs to and how FDA regulates it. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 Because the category follows the seller's intent rather than the package, the test has to look past the package. If only the immediate label counted, a seller could print a modest label and promote the product as a cure everywhere else. In the Nordic Clinical matter, the government made this point about Blood Boost: it called the immediate label "benign enough" and then pointed to disease-treatment claims in the product's labeling and promotional material. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 The test also reaches speech. One pretrial brief argued that distributing a promotional publication as labeling would inevitably be evidence of the plaintiffs' intended use of their product as a drug, which could potentially render their underlying magnesium supplements "drugs." Source: Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version] (FTC), quoting a federal court opinion on a supplement maker's First Amendment challenge

The FTC works from a different premise than FDA. As described in a respondents' pretrial brief before the FTC, the FTC's mandate is not based on the rigid categories of "food" or "dietary supplement" versus "drug." It asks whether claims are truthful, non-misleading, and substantiated. Source: Respondents' Pretrial Brief (Corrected Copy) [Redacted Public Version] (FTC) The two approaches meet in the Commission's POM Juice matter, where Complaint Counsel argued that a proposed Notice Order should require respondents to obtain FDA approval of the intended use before advertising a product to treat, prevent, or reduce the risk of a disease condition. Source: D09344 - Complaint Counsel's Reply Brief to Respondents' Answering Brief (FTC) Complaint Counsel also took the position that no FDA pre-approval is necessary for carefully qualified claims that convey a net impression other than that the product is effective for treating, preventing, or reducing the risk of disease. Source: D09344 - Complaint Counsel's Reply Brief to Respondents' Answering Brief (FTC)

Enforcement examples

Pearson v. Leavitt (publication about SAMe dietary supplements)

Pearson v. Leavitt, 189 F. App'x 161 (4th Cir. 2006)

Two formulators of SAMe dietary supplements wrote a prologue to a government report that suggested SAMe supplements were a possible treatment for various diseases, and they intended to sell the bound volume to the general public through their licensees. Source: Pearson v. Leavitt, 189 F. App'x 161 (4th Cir. 2006) They held back because they feared FDA would use the publication as evidence of the "intended use" of their supplements and reclassify the supplements as "new drugs." Source: Pearson v. Leavitt, 189 F. App'x 161 (4th Cir. 2006)

Outcome. The Fourth Circuit found the record insufficient to show that the case was ripe for review. The record had no indication of who would sell the publication, how it would be marketed, the purpose for which it would be used, or how it would be distributed, and those factors are a necessary part of the intended-use analysis. Source: Pearson v. Leavitt, 189 F. App'x 161 (4th Cir. 2006) The court contrasted two earlier honey cases. In one, jars of honey were unapproved drugs because booklets about the honey's disease-treating capacity were sold adjacent to the jars. Source: Pearson v. Leavitt, 189 F. App'x 161 (4th Cir. 2006) In the other, booklets claiming the curative power of honey were not evidence of intended use because they were shelved with other publications and were not marketed with the honey in any way. Source: Pearson v. Leavitt, 189 F. App'x 161 (4th Cir. 2006)

In re Search of Specialty Fulfillment Center (Nordic Clinical supplements and topical pain cream)

Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017)

Nordic Clinical labeled its Neurocet product a "dietary supplement" and offered an ingredient list to support that label. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 The government pointed to Neurocet's website, which said the product "helps get rid of pain all over your body," including pain from rheumatoid arthritis and osteoarthritis. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 It also pointed to promotional flyers sent as part of what it called Nordic's integrated marketing for Neurocet. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 For Blood Boost, whose immediate label the government called benign, the website compared the product to erectile dysfunction drugs, and a twenty-seven page booklet carried claims such as "The Cure for Disease as We Know It!" Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 For the ActaFLEX4x topical cream, the government said the package label's indications fell within the OTC monograph, but the website added indications such as "bursitis" and "tendonitis" that the monograph did not include. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128

Outcome. The government argued that the ingredients were irrelevant because the objective intended uses of Neurocet included curing, mitigating, treating, or preventing disease, which made it a drug. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 On that basis it argued that Neurocet was an unapproved new drug, was misbranded because its labeling was false and misleading, and was made in an unregistered drug establishment. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 It asked the court to deny Nordic's motion for return of the seized products, arguing they were contraband. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017)

Exposure

When a seller's marketing shows an intended use that makes a product a new drug, the product cannot lawfully enter interstate commerce without FDA approval. The introduction of an unapproved new drug into interstate commerce is prohibited. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 The exposure does not stop there. Drugs are misbranded if their labeling is false or misleading in any particular, and in the Nordic Clinical matter the government argued that labeling a drug a "dietary supplement" is false and misleading. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 The government's brief described the introduction of misbranded drugs into interstate commerce as a crime, and it described a manufacturer's failure to register or list as a crime. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128 Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (Exhibit D to Petition To Stay Investigation and Quash Civil Investigative Demands) (discussing 21 U.S.C. §§ 321(g), 331)

The Nordic Clinical filing showed how that exposure can play out for a business that wants its stock back. The government argued that the seized Neurocet, Blood Boost, and ActaFLEX4x were unapproved new drugs and misbranded drugs shipped in interstate commerce in violation of the statute, and that property of that kind is contraband that should not be returned even to a rightful owner. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017) It added that under the doctrine of unclean hands the court should not give Nordic the equitable relief it sought. Source: Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017)

Before the FTC, the exposure takes a different form. In the POM Juice matter, Complaint Counsel urged a proposed Notice Order under which, if the respondents wanted to advertise the products to treat, prevent, or reduce the risk of a disease condition, they would first have to obtain FDA approval for that intended use. Source: D09344 - Complaint Counsel's Reply Brief to Respondents' Answering Brief (FTC)

FAQs

1.Petition To Stay Investigation and Quash Civil Investigative Demands Filed By Encore Plus Solutions, Inc. and Nordic Clinical, Inc.. Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128
2.Petition To Stay Investigation and Quash Civil Investigative Demands Filed By Encore Plus Solutions, Inc. and Nordic Clinical, Inc.. Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (D. Idaho Dec. 1, 2017), quoting 21 C.F.R. § 201.128
3.Petition To Stay Investigation and Quash Civil Investigative Demands Filed by Encore Plus Solutions, Inc. and Nordic Clinical Inc. [Redacted Public Version]. Government's Response to Nordic Clinical's Motion for Return of Property Pursuant to Fed. R. Crim. P. 41(g) (Exhibit D to Petition To Stay Investigation and Quash Civil Investigative Demands) (discussing 21 U.S.C. §§ 321(g), 331)