If you’re selling a dietary supplement and think your tweets and Facebook updates are outside the realm of FDA’s rule – think again! FDA just cracked down on one company for its misleading claims posted on its website, Facebook and Twitter accounts. Let’s break it down.

The FDA closes out 2011 with a warning letter to Nenningers Naturals for making misleading claims for its products, Triple Flu Defense. The website claims this product can ease flu vaccine side effects, relieve flu symptoms, is a unique homeopathic product and made in a US FDA laboratory, Let’s take a quick look at what happened:

• Triple Flu Defense makes claims to treat conditions and/or diseases. This then automatically takes the product out of the dietary supplements category and into the drug category. The product is then evaluated as a drug by the FDA.
• Testimonials on a company website are considered as health claims marketed by a company.
• There is only one ingredient in the formula that is recognized as a homeopathic ingredient. In order for the product to be a homeopathic medicine, all ingredients must be recognized homeopathic ingredients recognized by the HPUS (Homeopathic Pharmacopeia).
• Twitter and Facebook updates state: “Start your weekly prevention now”. In case you haven’t noticed, it is a labeling requirement for dietary supplements to state the following disclaimer “This product is not intended to diagnose, treat, cure or prevent any disease.”

Looks like Nenninger’s in some trouble. The good news is that none of this comes as a shocker and those that think FDA is unreasonable and has grandiose plans to shut every company down should think again. Nenninger’s got caught red handed for simply not following the regulations. Stick to the regulations and you won’t have this problem. It really is that simple.

• Don’t make disease prevention or treatment claims.
• If your product is supposed to be a homeopathic product, then following the guidelines and formulate it as such.
• Don’t post testimonials that reflect prevention or treatment claims.
• Don’t tweet or update your Facebook status with prevention or treatment claims.

If your product is supposed to be a dietary supplement, then market it as such and label it as such and by all means, follow the regulations for dietary supplements.

What’s next for Nenninger’s? they have to make some (costly) adjustments to their website, product labeling and marketing campaign. They have 15 days to respond to the FDA and the response better be good. The longer you hold out or if you provide an ambiguous response, the harder FDA will follow up their enforcement.

This type of situation is quite common. I’m not sure if it’s purely a lack of regulatory knowledge on Nenninger’s part (especially if it’s a small startup) or if they intended to turn a blind eye to the regulations. Either way, it doesn’t matter – they got caught.

If you’re selling supplements, make sure you’re in the loop and follow the regulations!

If you’re a regular consumer: whether this product works or not, Nenninger’s was quite misleading to you, branding their product as a homeopathic product when it isn’t. On top of that, they state their product is made in a FDA approved laboratory. That statement really means very little and the product should be made in a GMP compliant facility, not laboratory.

Bottom Line: If you’re a supplement manufacturer or distributor, learn from Nenninger’s mistake. Watch what you tweet, what you post on Facebook and what’s on your website!