Illegal claims: What your ad agency doesn’t know could hurt you

Denied? Read about new FDA policies on imgbranding.comOctober 3, 2012 the FDA announced the results of their review of 127 weight-loss and immune health dietary supplement brands. Over 20% were boasting illegal claims and others lacked the scientific evidence to back their legal claims. Companies marketing those brands receive 14 days to remove the offending and/or unsubstantiated claims or face shut down. What kind of claims did the FDA find?

Here’s a few:

  • “Eat all you want! Block the starch and lose weight!”
  • “This advanced dietary-fat inhibitor helps block the absorption of fat calories.”
  • “Say goodbye to sniffles. This herbal blend stops cold and flu symptoms before they can spread.”

Other brands purported to cure cancer and treat HIV, which is strictly prohibited. As for scientific backing? Some referred FDA agents to Wikipedia, press releases, and their own ads. The most distressing aspect of this crack down is not that the FDA is policing supplement companies (most companies welcome the regulation), it’s the effect such claims have on consumer perception of the dietary supplement industry as a whole. Another unfortunate effect is that well-meaning companies read these exaggerated claims and, uneducated as to the exact restrictions, end up making illegal claims themselves.

So, what can you say, and what science is needed to back it up? I highly recommend working with an ad agency that knows how to navigate the intricate maze of guidelines listed in the Dietary Supplement Health and Education Act of 1994 (DSHEA). As the senior copywriter for an agency that specializes in natural products, my greatest challenge is often how to communicate the real, proven health benefits of a product without breaking DSHEA law. Here’s a few common challenges and possible solutions.

What to say

Regardless of how amazing the product is, if you are marketing it as a dietary supplement, you must tone down your claims to fit DSHEA restrictions. To write FDA-approved claims:

  • First, remove any mention of cancer, colds, flus or diseases.
  • Second, make sure your claims don’t reference treating, curing, or diagnosing anything.
  • Third, make sure your claims don’t purport to improve, enhance or increase anything.
  • Fourth, write about the benefits of your product in structure/function claims.
  • Fifth, make sure all claims are couched in terms of supporting or maintaining the body’s natural processes.

Here are some examples of dietary supplement no nos and their legal work-arounds.

Illegal Wording Legal Claims
Anti-inflammatory Supports inflammation within the normal range
Lowers blood pressure Helps maintain healthy blood pressure levels
Infection Immune challenge
Depression Low mood
Weight loss Weight management

Legal structure/function claims also need an asterisk, which references the FDA disclaimer. The disclaimer must be included on every dietary supplement package, ad and piece of marketing collateral. It must be formatted correctly and the type must be a certain size (basically, your customers need to be able to read it).

How to back it up

To enforce DSHEA guidelines, the FDA monitors labels, marketing collateral, and packaging, and the Federal Trade Commission (FTC) monitors advertising and public relations activity. When you submit an ad for publication, or when your PR team pitches a story featuring your product, the magazine or journal contacts the agency placing your ad and requests the science behind your claims. And when they say science, they do not mean a url or a Wikipedia entry. They want clinical studies—the placebo-controlled randomized kind that are published in peer-reviewed journals.

What you say about your company’s research is a claim in and of itself and, as such, must follow certain rules. Watch out for terms such as “clinically proven to…” or “research has proved…” While these bold claims are not illegal, they do require extensive backup if called into question. Terms such as “scientifically studied,” and “research has indicated,” may be a better fit for companies who have not yet published their research findings or who reference studies conducted by third parties.


While increased crackdown from the FDA may be worrisome for only a few, growing consumer mistrust weakens the dietary supplement industry as a whole. When writing claims that will appear on labels, packaging, print or digital media, use an agency that knows how to meet FDA requirements so you can tell your story in a way that compelling—and legal.

Sharon Benedict
Senior Copywriter
Integrated Marketing Group

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One Response to Illegal claims: What your ad agency doesn’t know could hurt you

  1. Very well said Sharon. We are lucky here at Albion to have our own inhouse legal council, he constantly talks about keeping to structure/function claims.

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