FDA & FTC Legal Update: Dietary Supplements and Cosmetics (Part 2)
In today’s video, we help you further understand potential exposure to the legal and regulatory quagmire of FDA and FTC liability.
Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare entrepreneurs just like you, navigate healthcare and FDA legal issues so that you can launch, or continue to scale your health and wellness product or service.
In the last video, I gave the alternative link for this talk and the title is: How NOT to Get Slammed Against the Regulatory Mat by FDA, FTC, & Other Alphabet Soup-Letter Agencies, Federal & State, as well as Private Plaintiffs; Or, How I Learned to Stop Worrying & Love False Advertising Law.
I also said that false advertising law shows up everywhere. We talked before about regulatory exposure to FDA and FTC. Today, I’ll talk about how the prohibition against false advertising is repeated, one way or another, in the statutes of many states. For example, in California, Business and Professions Code Section 17500 prohibits false advertising in general.
Whether we’re talking federal law or California law or the law of another state, in general, the law prohibits “unfair or deceptive acts or practices in or affecting commerce.” Companies must be able to substantiate their claims, meaning they must have a “reasonable basis” for each claim. For healthcare products there is an even higher standard, which under federal law is that the claim must be supported by “competent and reliable scientific evidence.”
In California, Business and Professions Code 17200 prohibits unfair business competition. I won’t go into 17200 in depth, but plaintiff lawyers make good use of 17200 as a kind of add-on to the many other types of business dispute claims that they might bring.
So now you know, false advertising is BAD, don’t do it. And if you’re a business lawyer, don’t let your distributor and manufacturer clients do things that will likely result in them getting nailed for false advertising.
But here’s one thing you might not have considered –What happens, for example, if you buy a product from someone, and simply repeat their claims? What if no one bothers to go after the original manufacturer or distributor, the person who make the bad claim in the first place? Could they come after you as a reseller? Yes, they could. Anyone who makes claims exposes themselves to risk and it doesn’t matter whether they got the claims from someone else who has so far been under the radar.
There’s no antibody immunity to false claims.
We talked about FTC. The FDA imposes an additional set of regulatory concerns.
We deal a lot with dietary supplements and cosmetics. For example, there could be a dietary supplement that says boosts immunity, but the manufacturer or distributor CAN’T say cures or prevents viruses, because that’s a drug claim. You might pick up a supplement in the store that says, promotes brain health but it won’t say prevents Alzheimer’s. One might say supports healthy digestion but can’t say prevents IBS. Again, these rules are additional to and on top of FTC’s prohibitions against false and misleading claims.
So, what is the solution to all this madness?
We’ll give you 3 quick recommendations:
First, a Broad View of Exposure: Understand that the risk is broader than getting sued, because if the FTC gets involved, FTC can take the company apart brick by brick.
Second, get Legal Review of Claims before you put them out on the Internet. Again, watch out for that FTC liability.
Third, think in terms of Risk Mitigation: An ounce of prevention is worth a pound of cure, so the best thing you can do is to get one step ahead of the regulatory agencies by thinking through your marketing with an eye toward possible FTC exposure.
Thanks for watching. If you still have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.
Testimonials
-
I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.
-
Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.
Contact Us
