In today’s video, we talk about legal risks and risk mitigation related to provision (once again) of IV therapies—and we focus on Federal Trade Commission (FTC) enforcement around false advertising charges.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you, navigate healthcare and FDA legal issues so you can grow, launch, scale, your healthcare business.

An FTC enforcement page on IV therapies is titled: “’A wise guy walks into a bar’ – but the punchline isn’t what you think.”

One recent enforcement action that’s featured in this press release targeted the manufacturers and an IV Bar promoting IV cocktails—“bags containing mixtures of water, vitamins, minerals, and amino acids administered through an IV drip.” Good for FTC, they got the definition.

Here, the business model involved having the customer fill out a questionnaire, which according to the FTC, “gets a quick online once-over by a doctor,” who receives a flat fee from the IV Bar company. Now you might think “flat fee, no kickback issues, no problem,” right?

But according to FTC, the company’s website overstated the claims of benefit, and included statements that the IV cocktail is effective as a treatment for “cancer, angina, congestive heart failure, multiple sclerosis, diabetes, fibromyalgia, neurodegenerative disorders, and other serious medical conditions.” So, you’ve got this litany of diseases and you don’t have the evidence.

Humorously, FTC noted that the benefits were said to include a remedy for “wedding disasters.”

FTC basically said the research touted by the company about the benefits of the well-known Myers Cocktail, was unsupported by the medical evidence; that the images on the company website (doctors, pills) falsely misled customers into assuming that there was scientific evidence where there was none or insufficient evidence for the claims.  Ultimately, the FTC said, there was no substantiation.

Claims that the products were “safe,” caused “no side effects,” or had been “clinically or scientifically proven,” according to the FTC, were false and misleading. So, watch out for those claims.

FTC’s enforcement order will now require “randomized, double-blind, and placebo-controlled human clinical testing to support any claim that its cocktails cure, mitigate, or treat any disease. The order also bans misrepresentations about the kind of medical professionals the company assembles to formulate, test, or approve its products.”

FTC (again, with a bit of humor) described its order as a “compliance cocktail.”

Yes, they have great writers.  They can also take your company down if you haven’t pre-reviewed your marketing claims and FTC decides you’re going overboard.

FTC goes on to describe some of the well-known legal requirements for non-misleading advertising.  The study (most importantly) got to constitute “competent and reliable scientific evidence” supporting the claim.  The study must actually involve the claim, and not involve different doses, formulations, routes of administration, or different species (that means animals instead of humans).

FTC noted that the IV therapy, “sometimes referred to as “Intravenous Micro-Nutrient Therapy,” “Intravenous Vitamin Therapy,” and “Hydration Therapy,” has recently seen an increase in popularity throughout the country.”

We are seeing an uptick as well in our client base, and we counsel our clients on compliance parameters, including reviewing all of their marketing material ahead of time for enforcement risk relevant to false advertising. An ounce of prevention worth tons of cure.

Following a public comment period, the Federal Trade Commission has approved a final order settling charges against a Texas-based marketer and seller of intravenously injected therapy products (iV Cocktails) who allegedly made the range of deceptive and unsupported health claims about their ability to treat serious diseases such as cancer, multiple sclerosis, and congestive heart failure. Those were things that were named on the website, or in other marketing materials by the company.

Thanks for watching. If you have other questions, please don’t hesitate to contact us. We look forward to hearing from you and hopefully to working with you soon!