Following are excerpts from a recent Warning Letter from the FDA to an overly conscientious dietary supplement company. This company was called on the carpet for a number of reasons, but all of them could have been avoided by careful use of language.
The consequences of an FDA Warning Letter are:
- Hiring an FDA trained attorney to respond to the FDA
- Taking down and re-writing your web site and other marketing materials
- Re-doing your labels
- Bad press and loss of reputation
- Loss of your market standing and loss of customers
All of them are very expensive. Let's analyze this letter to see why the FDA was so upset.
"This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address ____ and has determined that the products "_____\[6 products\]" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act(the Act) \[21 U.S.C, § 321(g)(1)(B)\]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act."
Let's stop right here and look at what the FDA is saying. "…they \[the products\] are intended for use in the cure, mitigation, treatment, or prevention of disease."
Here is Rule Number 1.
Under the FDCA, (Federal Food, Drug and Cosmetic Act), passed in 1938, only a drug can be used to prevent, diagnose, treat or cure disease in animals and humans.
Dietary supplements were not included in that description. As tempted as you might be, to proclaim the health benefits of your dietary supplement, you're breaking the law if you do it. There are other ways to point out the benefits of your products.
Now, back to the FDA letter. The letter continues, quoting passages from this company's web site:
"\[Product name\] supplementation has also been shown to be an effective adjunct treatment to conjunctive heart failure, angina pectoris, high blood pressure, arteriosclerosis, mitral valve prolapse and periodontal disease, as well as helpful in the treatment of muscular dystrophy, chronic fatigue, diabetes, allergies … AIDS …."
Let's look at how their language stirred up the FDA hornet's nest. The company listed a string of medical conditions and diseases. That's an elementary "No, No" in writing dietary supplement copy.
Don't ever put a disease name in your copy. Nope. You just don't dare do it. Don't even imply your product can help with a disease.
Your product may "Help, support a normal healthy heart, or a healthy pancreas," but no dietary supplement can "treat conjunctive heart failure, or diabetes. (And especially, never mention AIDS or flu of any type!)
Remember Rule Number 1: A dietary supplement cannot "prevent, diagnose, treat or cure disease in animals and humans."
And now, back to the complaints in the FDA letter. They continue quoting the errors on the company web site.
Rule Number 2
"… \[product name\] has been proven to be of significant value in alleviating the effects of the following: heart disease, high blood pressure, cancer … muscular dystrophy, multiple sclerosis, Parkinson's disease and periodontal disease."
"A new approach to Parkinson's disease was reported at the 2002 annual meeting of the American Neurological Association … and simultaneously published in the journal Annual \[sic\] of Neurology, Dr. Clifford Shultz and colleagues at the University of California, San Diego, showed that oral (product type) can actually slow the progression of Parkinson's disease."
Oh my gosh! Here they've broken Rule Number 1 again, and they're breaking Rule Number 2 in full force.
Rule Number 2: Quoting, citing, or even linking to an outside authority to support your claims becomes an FDA "Implied Claim."
You just can't do it. The implication above is that Dr. Clifford Shultz and colleagues endorse their product.
I'm sure that's not what the original writer intended, but that's the FDA logic. The FDA contends that the average Joe and Jane reading this web site will conclude that Dr. Shultz endorses the company product.
Please note that I listed links as an "Implied Claim." They seem so innocent, don't they? It's only a link for heaven's sake. But, the FDA sees it as an Implied Claim.
Keep your research in a file, but don't mention it on your web site. The FDA hornets will sting you for sure.
Let's read on. Now the FDA is quoting more of the web site violations.
"The message was clear: 15mg capsules of tomato lycopene helped reduce the size and severity of prostate tumors in men who took the capsules twice daily. As Omer Kucuk, M.D., delivered the message before the American Association of Cancer Research."
Here, the company is doing it again. I can see how hard a copywriter worked to gather research supporting the products. I did it myself until an FDA attorney slapped my hands for it. You want to supply third-party proof, but with dietary supplements you just can't break Rule Number 1 or Rule Number 2.
Rule Number 3
"This powerful anti-oxidant combination acts as … protection against certain types of cancer and decrease in the incidence of blood clotting and balancing the good and bad cholesterol."
And here, they're back to violating Rule Number 1. The "powerful anti-oxidant" is O.K., but "cancer" is a No-No. And, a dietary supplement cannot legally decrease blood clotting. Even if their supplement does help stabilize the blood, you can't talk about that. "Balancing the good and bad cholesterol" is dangerous territory because the FDA thinks only drug companies can help with cholesterol.
Rule Number 3: Don't try to compete with or take business away from the pharmaceutical companies.
Finally, this Warning Letter concludes with the boilerplate paragraph. Every Warning Letter from the FDA ends with this paragraph. What they're saying is that the language used to market the questionable dietary supplement, makes the product, de facto, a drug. If your product can do what you're claiming it can, then by definition it must be a drug. Since you're saying it's a drug, here's what you have to do to get it approved as a drug.
"Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act \[21 U.S.C. § 321(p)\]. New drugs may riot \[sic\] be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act \[21 U.S.C. § 355(a)\]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your (6 products listed) are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails to bear adequate directions for use \[21 U.S.C. § 352(f)(1)\]."
What Can You Say?
First, leave out any and all references to specific diseases. This is crucial in protecting yourself. The government uses keyword-checking software that just roams the Internet looking for disease references. That is the first way they find your site. That's how they found all those companies advertising prevention and cure for swine flu.
Second, no matter how tempting or true, don't include references to doctors, speeches, University research, or any other research. The FDA doesn't like that at all. Yes, it's true and scientific, but you can't do it.
You can say vague things like, "Recent studies have shown ______ to be helpful in supporting a healthy heart." (Be sure you have those studies in your files in case you're ever questioned about substantiation.)
You can say, "_____ will help you find new energy and zest for life. Or, saying, "______ helps support healthy blood circulation," is generally safe. Or, it's safe to say, "Lycopene, along with a healthy diet, contributes to the support of a normal, healthy prostate."
This language is not as dramatic as the original claims, but it won't get you an expensive Warning Letter.
The wisest marketing move any natural product company can make is to hire an FDA attorney to review all marketing materials before publication (and before the Warning Letter arrives.)
So, watch your language! Words can really hurt you when they're used carelessly.
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Pam Magnuson is a freelance copywriter specializing in nutraceuticals and dietary supplements. She is a member of CANI (Consultant's Association for the Natural Products Industry), American Marketing Association, American Botanical Council, and United Plant Savers. She is the author of "What Can You Say When You Can't Say Anything?" Her web site is: http://www.pammagnusoncopywriting.com. Learn about her new book at: http://www.avoidfdaredflags.com.
© 2009 Pam Magnuson Copywriting