Whenever you market a healthcare product, beware of potential FDA and FTC enforcement as well as private plaintiffs who can sue for false advertising, unfair competition, deceptive and misleading business practices , or some variation.
Let’s talk about the FDA and FTC enforcement hammers–they come down simultaneously, like keys in a piano chord. How do you minimize the risk of catching an FDA or FTC enforcement bullet? Here are four broad suggestions:
- Have your website reviewed by legal counsel. Understand that all marketing materials – including the website – can be considered part of your labeling, and in any event, can easily be searched and tagged by regulatory authorities.
- Recognize that FDA and FTC have overlapping jurisdiction in the consumer healthcare product market. Both are concerned that your claims be accurate, although FTC is more concerned with deceptive advertising, and FDA with consumer safety.
- Substantiate all your claims. Both FDA and FTC require that all products claims be supported by competent and reliable scientific evidence.
- Limit the number of claims on your website. The more claims, the bigger a target you paint for FDA or FTC to find an unsupported statement regarding your consumer healthcare market.
HCG, weight loss, and other enforcement hot buttons
One of the areas of heavy FDA and FTC enforcement is HCG. Sometimes companies think they can dodge these rules by selling “homeopathic” HCG. However, HCG is a drug that is not approved by FDA for weight loss. While physicians can make off-label claims, and FDA typically stays “hands-off” with regard to the practice of medicine, marketing HCG for weight loss will bring enforcement scrutiny. Among other things, FDA states on its site that OTC HCG products marketed as weight loss aids are “unproven and illegal.” FDA and FTC also have acted to remove homeopathic HCG weight loss products from the market by sending seven warning letters.
FDA also advises consumers to stop using homeopathic HCG for weight loss,. Weight loss claims are an area of particular scrutiny. Any company marketing a weight loss dietary supplement should review FTC’s “red flag claims”–the kinds of claims that definitely trigger strong FTC scrutiny.
For example, a claim that the product causes substantial weight loss no matter what the consumers eats. Similarly, claims of “fat blocking” or “fat absorption” are red-flag areas for FTC.
But even companies that avoid enforcement hot buttons such as HCG and weight loss supplements, face the generic category of healthcare fraud.
Proving fraud typically requires intent, as a legal matter; or sometimes claims can get added such as reckless misrepresentation. There are many arrows in the legal quiver.
FTC does not tolerate false and misleading claims of any kind. By subscribing to FTC’s updates, one can see the wide range of companies and products that have been subject to FTC penalties for overstating, over-claiming, claiming without substantiation, or otherwise misleading the consumer.
Substantiating claims–the evidence
Remember that even if the claims are not overstated, there is still the issue of substantiation. FDA and FTC will want to see the evidence supporting the claim; lack of competent and reliable scientific evidence will spell trouble. Our FDA and FTC attorneys and healthcare lawyers track healthcare legal developments so we can counsel our healthcare clients on their compliance legal obligations. Contact our FDA and FTC legal team for laws and legal counsel relevant to your situation.