What Can You Say When You Can’t Say Anything?

September 7, 2008

You're excited, and elated. Clinical trials have proven conclusively that your new product works . It's like being in love-you want to shout it from the rooftops! You've developed a dietary supplement that will really help people with anemia, or arthritis, or obesity, or macular degeneration.

You're excited, and elated. Clinical trials have proven conclusively that your new product works . It's like being in love-you want to shout it from the rooftops! You've developed a dietary supplement that will really help people with anemia, or arthritis, or obesity, or macular degeneration.

Then your elation dims, as you remember the strictures of FDA/FTC regulations for dietary supplements. You may be in love, but you can't tell the world about how wonderful your new product is. You can't cite your clinical trials, and list all your references that prove the efficacy and safety of your new product. You can't publish all those glowing testimonials.

Why? Because, if you do, FDA will consider your new naturally derived supplement a drug. Why a drug? Because in their minds, only drugs can “di agnose, treat, cure, or prevent any disease.” If it's as good as you say it is, then, it must be a drug.

What You Can't Say

You can never mention the name of a disease in your product labeling. Product labeling includes all of your written copy about your product: labels, Web sites, direct mail campaigns, brochures, and any other promotional literature.

How do you know if a “condition” is classified a “disease” by FDA? Go to FDA's Web site and search. Start by searching FDA warning letters about a certain condition or disease. Then search the condition itself.

Ask your self, “Is this condition something people go to the doctor about?” If your answer is “yes,” then you have a disease. Or, think, “Are there prescription drugs available for this condition?” If your answer is “yes,” then you have a disease.

What You Can Say

There are a lot of things you can say. You simply have to be very, very careful. You can't say your product will cure sickle cell anemia. But, you can say your product will help support and maintain normal healthy blood. No, it's certainly not quite the same thing, but you can say it.

The key words are: support and maintain normal healthy blood levels. You can use the words mild and occasional. You know your product involves things that are more than mild and occasional, but those are the words we must market with.

But you're not completely gagged. If you don't have one, get a good thesaurus. Because you can talk about symptoms (mild and occasional.)

Let's think about anemia. You can say, “Are you occasionally cold when others are warm?” “Do you sometimes feel tired and lack energy?” “Our product can help put the spring back in your step, and help warm your hands and feet. Our product can boost energy levels for those occasional times when you feel listless.” Use the qualifiers.

A tricky one is any form of arthritis. You can't mention the disease and you can't use the word pain. But you can talk about supporting and maintaining normal joint health. You can talk about being able to move freely, having your joints work as if they'd been oiled.

It all comes down to benefits. Your product can't cure the disease, so find other benefits of using your product. Focus on how much better the customer will feel, how their lifestyle will improve, how happy their family will be when they feel better. Your product can't cure acne, but it can help promote smooth, beautiful skin.

Implied Claims

You can talk about what your product contains and why it's good for the customer. But be careful here. Implied claims can get you in trouble. You have to be very careful when you talk about people being deficient in a vitamin, mineral, or other important substance. If you mention deficiency, you have to be able to state the percentage of people who are, but you can't reference your source.

If you reference your source, e.g., “The Mayo Clinic stated in a report dated February 17, 2004, that 70% of Americans are deficient in folic acid,” you could be in trouble. This statement implies the authority (the Mayo Clinic) agrees with and supports your claim. Just make sure you have the research on file. You'd be safer to say, “Many people need more folic acid in their diet.”

Testimonials are also implied claims. If a person writes to you and says, “I have sickle cell anemia. Three months after taking your products, the doctor said my blood counts were better than he'd ever seen them,” this is an implied claim, and you can't use it.

Even a book (covered under the First Amendment) can become an implied claim. If the book is on a shelf with other books, several feet or aisles away from your product, it's all right. But, if the book is on the same shelf, or in close proximity to your product, it becomes an implied claim. This includes books for sale on your Web site.

Footnotes, links to other sites, and lists of references are implied claims. By giving that information, you're implying those citations support your product.

You can say, “In clinical studies (your product) was shown to help support and maintain normal functions. ” Just be certain you have those studies on file, if you are ever questioned.

Other Companies Are Saying it. Why Can't I?

If you're a gambler, you can. You can take the risk of getting away with all kinds of claims. You'll sell some products that way. But, is it worth the hassle and expense of responding to an FDA lawsuit? Is it worth the loss of your reputation and the possible loss of your business?

FDA and FTC have the authority to fine companies millions of dollars, to enter your business with armed force and seize and destroy your inventory, destroy your manufacturing equipment, and burn your literature. They're authorized to use whatever assistance they want-the local police, swat teams, BATF personnel, even the National Guard, if they choose. And they do.

Eventually, FDA will find those other companies. They know companies are making “outrageous” claims. They just haven't gotten to them, yet.

That's one of the reasons why FDA asked for a budget increase this year. They want a larger staff to review dietary supplements.

Just remember, if your product can truly ease symptoms of disease, it must be a drug. Our government has restricted curing a disease to only pharmaceutical drugs. Play by the rules and be creative.

The best way to be safe is to send your written material to an attorney who specializes in FDA/FTC regulations. They're expensive, but cost less than a tussle with government authority.

Pam Magnuson is a freelance direct response copywriter. She is a member of the Consultants Association for the Natural Products Industry (CANI; Clovis, CA). For more information, visit www.cani-consultants.org or www.PamMagnusonCopywriting.com.