A Double Whammy – Joint FTC and FDA Warning Letter

February 25, 2013 By

Although rare the FTC and FDA have recently sent a joint warning letter to a company. An FDA warning letter can be scary enough, but a joint warning letter can cause undue hardship and financial ruin. It is wise for a company to practice due diligence and be sure to be in compliance before the FTC and FDA come knocking.

Be prepared for Joint FTC and FDA Warning Letter

You know your new year is not off to a good start when you receive a rare, but not unheard of, joint FTC and FDA Warning Letter from the Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”). On January 24, 2013, Flu and Cold Defense, LLC was given fifteen days to respond to both the FDA and FTC1. Failure to correct the cited violations may result in legal action without further notice, including, without limitation, seizure and injunctions by the FDA. But if you think that’s bad, FTC violations may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order, which could require that you pay back money to consumers.

While FDA and the FTC share jurisdiction for regulating the promotion of food and dietary supplement products, the FDA’s primary responsibility is for product labeling and the FTC’s primary responsibility is for advertising. “Labeling” is defined by the Food, Drug and Cosmetic Act to include “all labels and other written, printed or graphic matter (1) upon any article or any of its container or wrappers, or (2) accompanying such article.” FDA tends to interpret labeling broadly to include anything involved in the sales transaction, including written material sold with a product (or near a product in a store), and, in some cases, product websites. “Advertising” has been interpreted by the FTC to include all promotional materials other than the product label, such as print advertisements, commercials, and product websites.

Joint FTC and FDA Warning Letter Sent January 24, 2013

According to the FDA Warning Letter, the FDA and FTC reviewed the company’s websites and found that their product, GermBullet is a drug because it is intended to prevent, treat, or cure disease conditions. The FDA cited, among other claims, graphics on both the website and product label depicting a “germ” inside a target accompanied by the words, “COLD & FLU VIRUSES” and “BACTERIAL FUNGI” and the statement, “It is truly amazing. I wouldn’t be without it! Especially during this cold and flu season!” The FDA also contends that the company made false and misleading promotional statements on its website. Specifically, the company claimed, “An FDA recognized virology lab independently tested GermBullet® inhalation blend and confirmed that it has the potential capability to kill cold and flu viruses.” As it turns out, the FDA has not recognized any virology lab that has independently tested their product.

Last, but certainly not least, the FTC stated that under the FTC Act, it is unlawful to advertise that a product can prevent, treat or cure human disease unless you possess competent and reliable scientific evidence, “including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” The FTC further pointed out that it violates the FTC Act to make or exaggerate such claims, whether indirectly or indirectly, through the use of a product name, website name, metatags, consumers testimonials, or other means, which would include social media.

Don’t wait for the twin knocks on the door. Protect your company, and avoid a FDA Warning letter all together, by regularly review your labeling and advertising to be sure you are complying with all requirements of federal law, FDA regulations, and the FTC Act.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com