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Disease claims rampant in supplement advertising

You must have substantiation, but you cannot cite it in your advertising and labeling.

Marketers today are confused about citing sources of their research. They want to provide the substantiation required. They want the reader to know there is solid science behind their product, and they mistakenly think the FDA will be impressed with their diligence.

This is a major sticking point in my discussions with companies. They just can't understand why I won't cite studies and references, even in keywords.

Here is a good example where studies and references can lead to trouble. This FDA Warning Letter contains multiple mistakes made by the advertiser. Within this five page latter, most of the errors are about disease claims. One recent example is an FDA letter that is five pages long. Most of the errors have to do with disease claims. As promising as it sounds, one just cannot say a product is a "must" for people who suffer from:

  • Back, Neck & Joint Pain
  • Arthris \{sic\}
  • Fibromyalgia
  • Psoriasis
  • Lupus, IBS or Alzheimer's Disease"

Rule Number 1. Do not mention a disease name anywhere, anytime, for any reason.
Additionally, the testimonials of this company break rules, too, including one testimonial by a doctor, talking about his patient's cholesterol numbers. Even if the testimonial is written by a qualified medical professional, disease conditions cannot be mentioned. It will taint the entire web site or brochure.

In their well-intentioned zeal, this company cited numerous publications about the use of omega-3 fatty acids for treatment of arthritis and Alzheimer's disease. And, in doing so, created "Implied claims." We just can't do that.

Here's how the FDA Warning Letter explained it to the company:

"When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease."

The reasoning of the FDA is that "citation of a publication" in commercial (advertising) writing, becomes a disease claim because the publication or source talks about use of a substance (in this case omega-3,) with a disease. This then becomes "evidence of the product's intended use."

In other words, the claim is created by association. Even if the seller didn't mention disease names, the source cited will mention disease names. This implies the suggested use of the product being sold.

Some marketers have a difficult time grasping this concept. It seems unfair to them, and perhaps it is, but it is the law as it's written today.

Additionally, links and meta tags are considered citations, so you can't sneak it in that way either.

The FDA also looks at these citations as an implied "endorsement" of your product. Again, this is by "association." If A and B are walking hand in hand, you assume an association between A and B.

In other words, if you research omega-3 on the Internet and find that the Mayo Clinic has done studies with favorable results. you cannot quote that research. The implication would be that the Mayo Clinic endorses your product containing omega-3.

It's important, even necessary, to do the research, however. You can't use it in your marketing copy, but you must have it if the FDA comes around asking questions about substantiation. You must have substantiation, but you cannot cite it in your advertising and labeling.

There is one caveat. Research done by a third party on a similar product, or an ingredient used in your product is not true substantiation. The research must be on your identical formula to be of true value. Studies your company has done, or that third-party labs may have done on your product are of genuine value.

Web sites with long lists of citations, and re-prints of studies done are flirting closely with danger. Those companies think it will be impressive to the reader and help sell the products. Perhaps it does, but are those extra sales worth big trouble with the FDA?

Granted, it seems like we should be able to provide "proof" to the people who read our web sites and brochures, but, we are subject to the law at this time. If you watch your language, and just leave all citations and studies off your web site, life will be so much happier.

Pam Magnuson writes a monthly column for Functional Ingredients magazine called Watch Your Language. She is the owner of Magnuson copywriting and can be reached at

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