On February 11, 2019, the Federal Trade Commission announced that, in conjunction with the U.S. Food and Drug Administration, three warning letters were sent to dietary supplement companies based in Florida, South Carolina and New Mexico.
Recipients were advised that the FDA reviewed relevant websites whereupon orders are taken, and that claims establish that the products are drugs under section 20l(g)(l)(B) of the Federal Food, Drug, and Cosmetic Act (the “Act”) [21 U.S.C. § 321(g)(I)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. In addition, the Federal Trade Commission reviewed relevant websites for potential violations of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52.
Examples of some of the problematic claims observed that provide evidence that the products are intended for use as drugs include, without limitation, the following:
· “__________ has been shown to help eliminate allergies. ___________ is a powerful anti-inflammatory compound, which can significantly benefit arthritis sufferers.”
· “The ____________ included in the _____________ has been shown in some tests to help the human body’s immune system fight cancer.”
· “______________ supplements bought from ___________ also has benefits for patients suffering from Alzheimer’s disease. While there are ways to reduce the damages for Alzheimer’s by seeking its proper treatment, ___________ has in fact shown the benefits to help fight Alzheimer’s disease.”
· “[T]he number of diseases that ______________ cures has remained appropriately high. From chronic fatigue to dieabtes [sic] to lupus and hemorrhoids, __________ has been effectively accepted to be a major healer in the history of natural foods. This has been aided by its ability to satisfactorily provide treatments to various forms of complex diseases including other chronic and drug resistant diseases.”
· “_____________ pills are a popular natural treatment for insomnia.” · “____________ with ___________ for anxiety and insomnia is going to be all natural and the real deal when you order from ______________.”
The letters state that the products are not generally recognized as safe and effective for the referenced uses and, therefore, they are “new drugs” under section 201(p) of the Act [21 U.S.C. § 32l(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].
The FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. A drug is misbranded under section 502(f)(l) of the Act [21 U.S.C. § 352(f)(l)] if the drug fails to bear adequate directions for its intended use(s).
“Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(l)(A) of the Act (21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
The letters further states that the products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.
According to the letters, the products allegedly failed to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(l) of the Act (21 U.S.C. § 352(f)(l)]. The introduction or delivery for introduction into interstate commerce of the allegedly misbranded drugs violates section 301(a) of the Act (21 U.S.C. § 33l(a)].
The letters also set forth that the violations cited are not intended to be an all-inclusive statement of violations that exist in connection with the products. They reminded recipients of their responsibility for investigating and determining the causes of the alleged violations and for preventing their recurrence or the occurrence of other violations; and for ensuring that all products marketed comply with all requirements of federal law, including FDA regulations.
Unsubstantiated Advertising Claims
It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See POM Wonderful LLC v. FTC, 777 F.3d 478, 504-05 (D.C. Cir. 2015); FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008), affd, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat’) Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), affd, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75, 866, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007).
To make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See Daniel Chapter One, FTC Dkt. No. 9239, 2009 WL 516000 at *17-19 (F .T.C. Dec. 24, 2009), affd, 405 Fed. Appx. 505 (D.C. Cir. 20 I0).
The letters set forth concerns of FTC attorneys that one or more of the efficacy claims may not be substantiated by competent and reliable scientific evidence. The FTC strongly urged the recipients to review all claims and ensure that they are supported by competent and reliable scientific evidence.
The correspondence warned recipients to immediately provide information that supports the claims made, or to take prompt action to correct the alleged violations and to specifically outline the remedial actions taken.
The warnings are part of the FTC’s ongoing regulatory efforts to ensure that dietary supplements and other health-related products are advertised truthfully, and that efficacy claims made for such products are supported by competent and reliable scientific evidence.
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