| We face a special challenge in the nutraceutical/functional foods industry. As Marketing Copywriters, we can’t simply say exactly what a product does. Even if all of the research indicates Product X is a weight loss aid, or relieves joint pain, or boosts the immune system—we can’t say that. The FTC and FDA have highly stringent guidelines about marketing and advertising dietary supplements.
So, how on earth can we sell our product to people who would benefit from it? How can we tell them our product will help sickle cell anemia? We can’t say it benefits people with anemia. The FDA would interpret that as a drug claim, and then the food supplement would be treated as a new drug and be subject to those regulations.
I’ve read some of the warning letters the FDA has sent to companies about their product advertising. Here’s a quote from one, “...The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment or prevention of disease. The marketing of this product with these claims violates the Act.”
Even customer testimonials are viewed as claims. If your customer writes you to say that he was obese, but after using Product X, he solved the problem, the statement will be viewed as a claim. Obesity is classified as a disease, so if product X cured his obesity, then product X is a drug under FDA regulations. Your customer can say he feels great and people are complimenting him on his appearance, but never say that it solved his obesity.
Here’s an FDA comment about a testimonial: “Your web site also contains disease claims in the form of personal testimonials, including: ‘Being extremely over weight and with a family history of obesity, I had to lose weight. So I began taking [Product X]...and lost 24 pounds in four months.’” It seems innocent and straight forward enough, the word “obesity” sounded the FDA alarms.
So, what can marketers do and say about Product X to safely (and legally) convey the benefits of the product?
- Retain an attorney who is FDA/FTC savvy to review all your print and digital copy before publishing. This includes your web site, trade show materials, direct mail, brochures, etc. His fee will be worth keeping you out of federal difficulties.
- Use a copywriter who is educated in FDA/FTC regulations to write the material.
- Substantiate every claim you make.
If you are writing copy in-house, make sure the person writing has a thorough knowledge of FDA regulations for advertising. But, still have an attorney review it. Sometimes the writer on your staff is so close to the product, knows so much about it, that he won’t see the little red warning flags go up.
You want to use selling language. That’s what it’s all about anyway -- selling the product. You need to write in a voice your reader will identify with. You need to explain the benefits of using your product, but you can’t say what it really does.
This becomes a “dance” of words. Although you can’t say it will help people with sickle cell anemia or obesity, you can talk around it until your reader gets the point. If you have stayed clear of certain kinds of words, the FDA can’t say you “made a claim.”
Even vague generalities don’t pass. Saying, “some people have found their red blood count returned to normal,” will be construed as a claim. But, you can say, “people who take our product experience greater energy, healthier skin tones, and an increased feeling of well-being.”
This language certainly doesn’t have the “punch” we would like it to have, but in this current climate, we have rely on painting word pictures, using emotional appeals, addressing the “broad spectrum” (“maintains good health!”) and writing to the intelligence of our reader.
Anecdotal or historical evidence carries no weight with the FDA, at this time. Even though generations of people used pomegranate for centuries to deal with a certain health issue, the FDA does not give credence to this fact. It’s not considered a valid, scientific clinical trial. Even the fact that we’re all alive is not considered valid evidence to the FDA.
- Retain an attorney specializing in FDA/FTC regulations;
- Hire a copywriter who is FDA/FTC savvy;
- Testimonials need to be edited to remove “claims”;
- Substantiate all claims.
The pressure is on the nutraceutical industry, and the situation is not likely to improve in the near future. There is a vast and growing public demand for healthy alternatives to prescription drugs, as evidenced by the rapid growth of the dietary supplements industry.
The major improvements will have to come from Congress, to curb the growing domination of FDA regulations. It may take time, but with the baby boomers reaching the age of power and influence, there is light at the end of the tunnel.
In the meantime, play by the rules and use carefully chosen words to safely and legally convey your product benefits.
© Copyright 2008 Pam Magnuson Copywriting
What Can You Say When You Can’t Say Anything?
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, the FDA will consider your new naturally derived supplement a drug. Why a drug? Because in their minds, only drugs can “…diagnose, treat, cure or prevent any disease.”If it’s as good as you say it is, then, it must be a drug.
You can never mention the name of a disease in your product labeling. Product labeling includes all of your written copy about your product: bottle labels, web sites, direct mail campaigns, brochures, and any other promotional literature.
How do you know if a “condition” is classified a “disease” by the FDA? Go to the FDA 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 an FDA disease. Or, think, “Are there prescription drugs available for this condition?” If your answer is “yes,” then you have an FDA disease.
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 does 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. Support and maintain normal healthy cartilage functions for a happier life style.
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 life style 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.
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, “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. 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 Free Speech 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.
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?
The FDA and the 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, the FDA will find those other companies.. They know companies are making “outrageous” claims, “Our product can cure cancer!!!” They just haven’t gotten to them, yet.
That’s why the 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.
© Copyright 2008 Pam Magnuson Copywriting
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