The Natural Products Foundation (NPF) has called on regulators to take action against 13 dietary supplement firms making unauthorized disease and drug claims about dietary supplements.
The NPF met Richard Cleland, a director at the Federal Trade Commission’s (FTC’s) advertising division, along with the Food and Drug Administration’s (FDA’s) health fraud coordinator Gary Coody last Friday to present documentation regarding 13 firms that had failed to amend marketing materials after being contacted by NPF’s Truth in Advertising (TIA) program.
Some of the firms had ignored warning letters, while others had amended materials following initial contact from the NPF, but then reverted back to making non-compliant drug claims, said NPF executive director Deb Knowles.
Many still unaware that supplements cannot claim to prevent, treat or cure disease
Although the FTC had only taken action against a handful of the companies identified by TIA as non-compliant last year, this did not mean the initiative had been ineffective, stressed Knowles.
“While we want the FTC/FDA to take enforcement action against companies that break the law, the purpose of the TIA program is to educate advertisers and help the industry regulate itself, and it has been enormously successful.
“The vast majority of companies we contact do amend their adverts. In many cases, companies are simply not aware of the detail of the law and think they can run testimonials, regardless of what they say, or make any claim as long as they have clinical evidence to support it, when in fact the law says dietary supplements cannot claim to prevent, treat or cure disease.”
Both the FTC and the FDA had agreed to review the material provided by the NPF, said Marc Ullman, a partner at New York City-based legal firm Ullman, Shapiro & Ullman and chairman of the NPF legal advisory council.
He was joined at last Friday’s meeting by NPF president (and Natural Products Association chief executive) John Gay and NPF board member David Brown, boss of LifeVantage Corporation, which markets antioxidant supplement Protandim.
77 warning letters
The NPF has mailed 77 warning letters to dietary supplements companies making drug and disease claims in the past year under its TIA initiative.
The initiative works to educate publishers, manufacturers, suppliers, and retailers to ensure that the information presented to consumers concerning dietary supplements adheres to the law.
During the 2010 Truth in Advertising campaign, NPF notified the FTC of 12 companies which did not comply with the law and were unwilling to amend their practices, said Knowles.
Health claims and dietary supplements
Under the 1994 Dietary Supplement Health and Education Act, any claims to prevent, treat, or cure a specific disease are expressly prohibited unless they have been approved by the FDA (eg. ‘diets high in calcium may reduce the risk of osteoporosis’.)
However, manufacturers can make claims describing the supplement's effects on the structure and function or general well-being of the body (’calcium builds strong bones’), as long as they are truthful and bear the following statement, ‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.’
While the FDA is responsible for policing claims made on product labels, the FTC is responsible for policing claims made in advertising and other marketing materials.