The Natural Products Foundation (NPF) recently met with officials from both U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) to turn over the names of 10 companies that have continued to make drug or disease claims in their advertising and other promotional materials. These meetings were part of an ongoing effort through the foundation’s Truth in Advertising (TIA) program, which aims to first educate advertisers to help them bring their advertising into compliance.
“There is no excuse for companies to be making drug and disease claims given the many ways they can find out how to make their materials compliant,” said Marc Ullman, veteran industry regulatory attorney of Ullman, Shapiro & Ullman, and chair of the NPF Legal Advisory Council. “When we notify a company about non-compliant ads and they continue to make illegal claims, they need to know that isn’t the end of the matter — there are repercussions.”
Ullman attended the meetings with NPF Executive Director Tracy Taylor. According to Taylor, both agencies were “very receptive and offered encouragement for our self-regulatory efforts.”
“The good news, which we reported during our meetings, is that out of the 21 companies that have received letters as part of the Truth In Advertising program, several have already undertaken substantial efforts to bring their advertising into compliance — including taking down a website, ” Taylor said. “In addition to the TIA material we turned over to the FDA and FTC, we have also provided those agencies with information concerning seven other websites making serious disease treatment claims — including H1N1 cures — as we believe that this type of claim requires an immediate regulatory response.”
Under the TIA program, a first of its kind self-regulatory program, the foundation embraces the basic principles that any advertisement or marketing materials must be truthful, not misleading, and substantiated under the requirements of both the Federal Food Drug and Cosmetic Act (FDCA) as amended by Dietary Supplement Health and Education Act (DSHEA) and the Federal Trade Commission Act:
•Not making claims, either expressly or implied, that are not accurate and fail to adequately disclose qualifying information
•Verifying that there is adequate substantiation for claims being made, including the level of support, type and quality of evidence presented, and relevance of the evidence to the claim.
•Not making claims through testimonials or expert endorsements that cannot be substantiated.
•Ensuring that claims based on traditional use have the appropriate substantiation or clearly communicate that the sole basis for the claim is its history of use for a particular purpose.
•Ensuring that claims are appropriate for dietary supplements and do not cause the product advertised to be a "drug" under the FDCA.
•Using the two-part disclaimer as stipulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994 when appropriate.
•Strictly adhering to the use of "third party literature" as defined by DSHEA.
The program, which is funded by industry companies, includes extensive educational information on the foundation’s website to assist companies in need of guidance: Truth in Advertising Resources.
“While enforcement is vital, our first goal remains to educate and assist advertisers in becoming compliant,” said Randy Dennin, chairperson of the Natural Products Foundation. “I am gratified that a number of companies that received our TIA letters are working hard to come into compliance. We are committed to leveling the playing field for ethical, trust-worthy supplement manufacturers.”
Companies that want to proactively become members of the Truth in Advertising program can take the foundation’s pledge: Truth in Advertising Pledge (PDF).