Product Claims: Considerations Based on What NOT to Do

A question often asked by clients in FDA-regulated industries is, “What claims can I make?” Unfortunately, this is a difficult question to answer.

There are many variables involved in accurately responding to this seemingly simple question; including the type of product, what the claims are implying, whether the claims are within the scope of the product category, and a whole host of other considerations. To truly know what claims you can make would necessitate a full review of your products and marketing materials. However, in a far more straightforward manner, we can guide companies on what not to claim. You see, warning letters, guidance documents, and compliance policy guides allow for industry to learn from the mistakes of others and hopefully not repeat them.

These documents offer good insights into what cannot be claimed.

So, it’s wise to pay attention to them, as we do.

To avoid enforcement actions against you or your company, let’s go over some general guidelines on what to consider when determining what NOT to say in product claims.

1. Stay away from claims regarding diseases or conditions unless expressly allowed.  There are categories where certain diseases and/or conditions can be called out in marketing.

   These include medical devices and drugs. But, outside of these, the allowable disease claims are more limited. A disease or condition claim on a food, supplement, or cosmetic is generally not allowed. Examples include “lowers your chance of heart disease” on a food product; “Prevents cold and flu” on supplements, or “treats eczema and acne” on cosmetics. Keep your claims within the bounds of the category to ensure that they are not violative.

2. The FDA looks at your marketing from the perspective of a “reasonable consumer” When reviewing your marketing, the FDA uses the perspective of a “reasonable consumer” and what they would think the product is sold for. I.e., its purpose.

   If the intended use of the product is not clearly understood by the consumer, then it may be a good idea to go back to the drawing board.

   Make sure that you are looking at the product and its marketing as a whole and not in a segmented way.

   Try to put yourself in the consumer’s shoes to ensure the purpose of your product is clear. This will help in determining what the FDA’s review will see as well.

3. Implied claims are just as dangerous as express ones Just because you are implying something doesn’t mean the FDA will not consider it a claim. An example is the difference between “treats cold and flu” which is expressed and “supports the body’s immune system when suffering from a cold or the flu” which is implied. Implications can also come from the product’s packaging graphics and product name which FDA will take into consideration when determining an intended use. Keeping these considerations in mind will help when crafting claims and marketing materials while ensuring that your company is limiting the risk of enforcement action against it. You can stay informed with more detailed information on claims in the coming briefs where we will take a deeper dive into each product category. If you are in doubt about any of your claims, have your marketing messaging, website, and or labels reviewed by an FDA Compliance attorney. For review or personalized guidance, contact Bustos Law Group today for a free, 30-minute consultation. We’ll discuss all concerns you may have about your FDA-regulated products. Call 1-832-592-7851 or book an appointment online, HERE