Warning Letter points to ‘blurring of the lines’ between FDA & FTC

Previously FTC and FDA have issued joint letters, as was seen for various swine flu products, but Warning Letter No. 2011-NOL-08 is believed to be the first issued by the US Food and Drug Administration (FDA) that tells the recipient to also respond to the Federal Trade Commission (FTC).

An unprecedented response​

Commenting independently on the warning letter, Ivan Wasserman, a FDA legal specialist and partner at Manatt Phelps & Phillips in Washington, DC, told NutraIngredients-USA.com: "While there are clearly problems with the claims cited in the letter, there is nothing to suggest that they are so unusual that they triggered this unprecedented response.​

“What this indicates is, following last year's FTC settlements with Nestle and Iovate which require the companies to have FDA approval prior to making certain claims in advertising, an increasing level of FDA-FTC cooperation and a blurring of the lines between the two agencies’ laws and jurisdictions,”​ said Wasserman.

Cara Welch, PhD, scientific and regulatory affairs manager for the Natural Products Association (NPA), told NutraIngredients-USA that NPA is interested to see where this apparent increased level of co-operation will lead. Dr Welch added that it is known that the bodies have worked together previously but this was the first time, as far as NPA is aware, that FDA has told the recipient to also respond to the FTC.

Sharing jurisdiction​

New York-based food attorney Marc Ullman from Ullman, Shapiro & Ullman LLP explained that jurisdiction over the internet has been commonly shared by FDA and FTC as it can easily constitute advertising (FTC) and labeling (FDA).

"Recent warning letters suggest that FDA has finally concluded that it is possible to police some of these claims without leaving your desk, whereas FTC has been focused on the web for some time,"​ added Ullman.

The letter​

The warning letter, dated February 1, 2011 and available to read here​, was sent to Tennessee Scientific, Inc./Scientific Formulations LLC regarding alleged drug claims for dietary supplements.

Signed by Patricia Schafer, acting district director, New Orleans District, FDA, the letter concludes: “In addition, FTC strongly urges you to review all claims for your products and ensure those claims are supported by competent and reliable scientific evidence. ​

“Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require you pay back money to consumers. ​

“Please notify FTC, via electronic mail at healthproducts@ftc.gov, within fifteen (15) working days of receipt of this letter of the specific actions you have taken to address FTC's concerns.”​

Wasserman said it would be difficult to predict if such letters will become common practice, since the letter came from the New Orleans District Office, not Rockville. “However, this shows that it is more important than ever for supplement companies to fully understand this evolving landscape and both agencies’ regulatory priorities,”​ he said.

"I do not believe that any other letter from FDA referencing the FTC has been generated by a district office like this one,"​ added Ullman. "The previous letters have come from FDA and FTC headquarters."​

The problems with the cited claims​

The warning letter deals with claims made by Tennessee Scientific, Inc./Scientific Formulations LLC on the company’s websites www.theformulation.com​ and www.scientificformulations.com​.

According to the letter, “FDA has determined the products NAC Supplement, Antioxidant Supplement, Anti-Angiogenesis Supplement, and Immune Enhancement Supplement are promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. ​

“The therapeutic claims on these websites establish the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act,” ​it states.