What Dietary Supplement Companies Need To Know About Claims Substantiation And FDA/FTC Compliance: Important Information for Supplement Companies from Alan Feldstein’s Presentation at Supply Side West
On November 14th, Alan Feldstein, Of Counsel to Collins, McDonald & Gann, spoke about claim substantiation for dietary supplements at Supply Side West in Las Vegas. Here are some of the highlights from Alan’s speech:
- To be successful, supplement companies must advertise the effects of their products by making claims. Stronger claims may require more substantiation
- The net impression of the claim is what must be substantiated, not necessarily the claim’s literal language. For instance, say a company makes the claim that its product is “doctor-approved.” Imagine that the company substantiated this claim by having five theologians with PhDs endorse the product. The claim is literally true—“doctors,” though not medical doctors, approved the product. However, the net impression is misleading. The claim makes it appear that medical doctors, not theology PhDs, support the product’s use; that is the assertion that must be supported.
- Unsubstantiated claims invite enforcement by the Federal Trade Commission, the Food and Drug Administration, state District Attorney Offices, groups like the Better Business Bureau and plaintiff’s lawyers who file class action lawsuits.
- FTC has typically applied a substantiation standard of “competent and reliable scientific evidence” to claims about the benefits and safety of dietary supplements. FTC case law defines “competent and reliable scientific evidence” as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
- While the FTC standard doesn’t say much about what will satisfy FTC, it makes one clear point: There is no magic document that will substantiate a claim, like a cross to a vampire. A lone in vitro study, animal study, or even double-blind placebo-controlled peer-reviewed study—the gold standard of claim substantiation—likely will not placate FTC. Instead, a combination of all of the support that a company can gather is best.
- Compiling a comprehensive claim substantiation package may not only satisfy FTC, FDA, and other regulators, minimizing a supplement company’s legal exposure, but may also assist a company in determining what claims are appropriate. Research may weed out some claims, but allow the company to make others based on the product’s observed effects.
Legal counsel who are experienced in dealing with FTC/ FDA enforcement actions and compliance measures, District Attorney Offices, and other regulators can make all the difference if one of those agencies demands that you provide substantiation for your claims. As experienced leaders in FDA law, the attorneys at Collins, McDonald & Gann work closely with supplement companies, scientists, and experts to try to build a substantiation package as bulletproof as possible, offering important legal counsel when it comes to all phases of FDA compliance and regulatory guidance. And if a regulator comes knocking at your company’s door, we can help you respond to attempt to minimize the legal repercussions that come with regulatory enforcement.
As always, if you would like any more information about claim substantiation or dietary supplement regulatory law, call us at 516-294-0300.
If you have a legal matter or question surrounding dietary supplement law/FDA Law, or are faced with an FDA Warning Letter, possible supplement recall or criminal charges surrounding dietary supplements, you need experienced counsel, straight answers and prompt attention. Call the dietary supplement lawyers of Collins, McDonald & Gann, P.C., at 516-294-0300 today to discuss how we can help in all aspects of dietary supplement law. We may be reached via facsimile at 516-294-0477 or by email email@example.com.