If you’re a dietary supplement manufacturer or distributor, know that FDA and FTC now encourage the public to report dietary supplement labeling violations.
FDA and FTC Rolls Out of the Welcome Mat to Consumer Reporting
Ever bought a dietary supplement or other health-related product that didn’t work as promised? Maybe you had side effects, or the claims just seemed unbelievable. Know this: the government holds companies accountable for making baseless claims about products marketed as dietary supplements.
Dietary supplement manufacturers and distributors have always had to worry about FDA enforcement action, as well as FTC enforcement action, for making claims that violate the law. This includes:
- Disease claims – claims that a dietary supplement essentially will cure or treat a disease (such as, for example: arthritis, diabetes, cancer).
- Unsubstantiated claims – claims that cannot be proven by competent and reliable evidence.
- Claims that are otherwise deceptive, false, or misleading.
The new post urges consumers to tell Uncle FDA or Uncle FTC if:
- You bought a dietary supplement that didn’t work as advertised – or you had an adverse reaction or illness.
- You’re suspicious that a company is making false or overstated claims in its labeling or marketing. (Watch for claims about so-called “treatments” or “cures” for diseases like Alzheimer’s, cancer, heart disease, arthritis, and others. Dietary supplements cannot lawfully claim to diagnose, mitigate, treat, or prevent a disease.)
- You’re concerned about the content, purity, or safety of the product.
Consumers are also encouraged to report adverse events. While this of course promotes consumer safety, it also provides another doorway to enforcement scrutiny.
Dietary Supplement Companies Need to Take Legal Action to Mitigate Enforcement Risk
The new welcome mat for consumer reporting means dietary supplement companies need to take action now, more than ever, to mitigate enforcement risk.
One thing dietary supplement companies don’t realize is that every statement on their website that says something about the product, can be considered a claim.
Many clients come to us to ask for legal assistance in drafting their “label.” What they don’t realize is that FDA and FTC will take enforcement action if the “labeling” is false or misleading in any way, and that FDA will take enforcement action if the labeling makes disease claims.
So for example, if the dietary supplement company says that the product can not only support immunity, but also give you brighter skin, more hair, help you shed pounds … and the list goes on and on … each of these claims must be vetted by legal counsel to ensure that the claim does not run afoul of regulatory tripwires.
Labeling can include:
- The website
- Company approval of consumer testimonials that make disease claims (“after taking this supplement, I didn’t need another round of chemotherapy!”).
- Postings on social media
- Statements by company officials to the media (radio slots, TV interviews)
- And much more
The Bottom Line
FDA and FTC can be tough as nails when it comes to enforcement.
There’s no telling that FDA will simply issue a “warning letter” (which by the way is public anyway) and let any particular company off without further enforcement action.
We applaud efforts of law enforcement officials to enhance consumer safety. At the same time, as lawyers who represent dietary supplement manufacturers and distributors, we recognize the perils of unanticipated enforcement scrutiny. There are plenty of legal traps for the unwary out there.
As more evidence accumulates for the health and wellness benefits of a healthy lifestyle, including nutrition and judicious use of dietary supplements, more and more businesses are jumping into the dietary supplement industry – even if only through a “white label” approach to branding.
The truth is, if you’re going to put a dietary supplement out on the market, you need to fully understand the regulatory perils. Ask experienced dietary supplement counsel to review all of your marketing materials, to help you mitigate FDA and FTC enforcement risk by vetting your dietary supplement labels, labeling and claims.