The line between dangerous and danger-free claims is thin and growing thinner every day. While your ad header or sell sheet may seem perfectly harmless, (after all, the competition seems to be saying practically the same thing), to grow a brand with longevity, you need to know how to stay off the FDA/FTC radar.

1. If using a claim other than a structure-function claim, have it reviewed by the FDA prior to use. Why do so many supplement companies use structure-function claims?

This is the only type of product claim that does not need to be reviewed by the FDA prior to use. A structure-function claim details how a product supports the natural function of a system or systems within the body. An example of a structure function claim would be: supports healthy digestive function. Other types of claims, which are fine for foods but not for supplements, need to be submitted for review and approval to the FDA prior to use. These include health claims (proven to reduce cholesterol levels) and nutrient content claims (high in fiber).

2.  Only use the term clinically proven if the placebo-controlled, peer-reviewed study was done using your product.

Lets say your ad agency uses the verbiage clinically proven in an ad to describe your product. Should you be worried? It depends. If you have the following to back up the claim, go ahead: 

      --You have conducted a placebo-controlled, randomized study

      --The study used your ingredient or finished product as the active agent in the study

      --The study is published in a peer-reviewed journal

To be published in a peer-reviewed journal requires that the results are statistically significant and that the study has taken other confounding variables into account. Steer clear of the term if:

       --Research exists, but it wasnt done on your product (consider the phrase research has shown)     

       --Research exists, but the results havent been published (consider the term clinically researched)

3.  Add a modifier to structure-function claims indicating a non-disease state. Lets say you are developing a product that helps manage inflammation.

 It used to be that you could use a structure-function claim that referenced normal ranges, For example, you might have said your product could help maintain inflammation within the normal range. This was fine a few years ago, but recently the FDA and FTC have started rejecting these claims.

To clean up your advertising and get back into the good graces of these institutions, include language that specifies an instance in which inflammation is normal. You could safely say, for example, that your product helps maintain inflammation within the normal range following strenuous exercise.  Exercise results in inflammation in healthy individuals, therefore, this is considered a normal instance of inflammation, not a disease state. If your product is designed to support joint health, you could also refer to muscle pain following exercise, or restricted range of motion following exercise. Again, you are making it clear that this claim is limited to non-disease states.

Normal instances (non-disease states) that can contextualize structure-function claims include:

      --After strenuous exercise 

      --During pregnancy

      --During menopause

      --Natural aging process

      --Biological processes used to maintain health (healthy immune function)

Summary

The FDA has over 33,000 articles on what supplement companies should and shouldnt do when marketing their products. While I would never recommend publishing an ad that hasnt been through legal review, I would also recommend using an ad agency that stays up-to-date on these continuously shifting requirements. After all, do you want to find out your ad wont pass legal muster before or after the concept is finalized?