With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary Supplement

On March 31, 2020, the Food and Drug Administration issued a Warning Letter to a dietary supplement firm for making claims about its products that establish the products are unapproved new drugs, in violation of Federal Food, Drug, and Cosmetic Act (FD&C Act), because they are intended to cure, mitigate, treat, or prevent disease.¹ According to the Warning Letter, the products in question were labeled as dietary supplements; however, based on a review of information on the company’s websites, Amazon storefront, and social media, including labeling in the form of citations to scientific publications or references, and literature included with the sale of a product, FDA determined the intended use of the products to be drugs.  Notably, some of the information the agency used in its determination were on the company’s social media website in Spanish.

Highlights

In the Warning Letter, FDA outlined numerous claims that it observed on the company’s websites, Amazon storefront, and social media accounts for the products, which served as evidence of the products’ intended use.

Firm’s Website

FDA took exception with several claims present on the company’s website, which served as evidence of the products’ intended use.  Examples of disease claims found on the company’s website included:

“ANCIENT ORIGINS The medicinal qualities exhibited by the ancient remedy Shilajit are due to the presence of Humic acid (HA) and fulvic acid (FA) . . . Shilajit has been used in oriental medicine for centuries to treat . . . diabetes, skin diseases, rheumatic pain, kidney stones, heart ailments, leprosy . . .”

“A pure calcium bentonite green clay, such as KK Clean ClayTM . . . has strong ionic properties that bind (chelate) molecules such as heavy metals, toxins and pathogens and holds them till they are removed from the body.”

Citations to Publications

FDA also took exception with several of the citations to publications or references on the company’s website, which served as evidence of the products’ intended use.²  Examples of citations on the company’s website FDA relied on as evidence of the company’s intent to market the products for disease treatment or prevention as drugs include references to articles in medical journals about Alzheimer’s disease and diabetes.

Social Media Website

FDA noted in the warning letter that it confirmed that the company’s social media website directs consumers to the firm’s website to purchase products. The firm’s social media website included claims in Spanish.  Example of disease claims found on the firm’s social media website include references to depression, asthma, and anemia.

Amazon Storefront

The firm provided product purchase links from its website to its Amazon storefront.  FDA took exception with several of the product description and cited them as evidence of the firm’s intent to market an unapproved new drug. For example:

“Fulvic and Humic Acids are the best solution to . . .absorbing the minerals and electrolytes[.] . . . A Few Symptoms That May Indicate Mineral Deficiency: . . . Depression . . .Arthritis . . . Heart Palpitations . . .Allergies . . .Asthma[,] Glucose, Cholesterol, or Anemia Problems[.]”

“The latest Breakthrough in Vitamin D supplementation . . . A Few Symptoms That May Indicate Vitamin D Deficiency: . . .Diarrhea . . . Inflammation . . . Fibromyalgia, [and] Chronic Fatigue Syndrome[.]”

Labeling Included with Shipment of Product

According to FDA, literature that the firm enclosed with shipped customer products also contained evidence that the firm intended their products for use as drugs.  For example:

“KK EDTA with Selenium and Minerals . . . Helpful for ASD, Alzheimer’s, heart disease . . .”

“KK Humic/Fulvic Minerals & Electrolytes . . . Crosses the blood brain barrier to remove mercury, heavy metals, and pesticides from the brain and body . . . antiviral, and anti-tumor[,] Reverses arthritis . . .”

AGG Observations

• Including information in product labeling that an ingredient has a history of use as a treatment of a disease in a form of traditional medicine can be considered a disease claim.
• FDA will purchase samples of products to determine if labeling included with the purchase contain information that constitute disease claims. (When I worked at FDA, we did this frequently.)
• Information provided in a social media website or a publication that can be determined to be under the control of the company can constitute disease claims for that company’s products.
• Portions of labeling in languages other than English can be translated by FDA and used to establish the intended use of a company’s products.
• Companies should create internal review committees, consisting of regulatory, medical, and, if appropriate legal (depending on company policy), to review any promotional material distributed about dietary supplement products to ensure regulatory compliance and minimizing drug-like claims violations.

[1] See Warning Letter dated March 31, 2020, available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketokerri-llc-598163-03312020

[2] According to 21 C.F.R. 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.