In today’s video, we discuss the dangers of marketing products without proper legal review—in this case, not just FDA enforcement, but even more significantly, FTC (Federal Trade Commission) action.  We talk also about ways to manage FTC enforcement risk when you have your FDA and FTC attorneys review your Web, your online and digital marketing copy.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand healthcare industry clients on health and wellness, FDA legal issues.

Today, I’m going to walk you through what happened when the FTC did something, and you’re about to find out why the manufacturer of these three pills got slapped with a 38 million dollar fine.

In a nutshell, the targets of FTC’s enforcement here were marketing dietary supplements to older Americans, falsely claiming, according to the FDA, that the pills could “stop pain and treat age-related ailments.”  The claims included promises that the healthcare product could treat join, back, arthritis and headache pain, inflammation, stiffness, and provide stronger and longer-lasting pain relief than pain drugs.

FTC said here that the defendants made claims that were not supported by scientific evidence.  Instead, they were promising “miracle cures to people who needed real medical help.”  FTC emphasized that anyone who markets a dietary supplement must have scientific evidence to back up their health claims.

Notice here that the penalty was 38 Million Dollars.  That’s a hefty price tag for not having your healthcare products reviewed by FDA/FTC legal counsel.  One false slip and FTC can find evidence that your products, are being marketed without enough evidence.  Remember that FTC can find all your marketing online, including your website and social media sites. It’s so simple, you know, type right in and google will find it.

Every once in a while, we hear from a client who thinks that enforcement is a joke.  “What are they going to do, slap me with a warning letter?”  Well, a 38 million-dollar penalty is going to do some more than damage to your wrist.  When FDA puts a company in its crosshairs, the consequences can be severe. It’s tough to get out of.

And, FTC is looking at your claims, which means that language matters.  So if you market your product, for example, to treat pain, then FDA can simply do something like a search for something like “pain” and “dietary supplement” and find your product.  Then, game over.

So be wise and have your dietary supplement, cosmetics, and medical device, and consumer products claims—reviewed by FDA and FTC lawyers.

Thanks for watching. Sincerely, here’s to the success of your healthcare venture, and we look forward to connecting with you soon.