What supplements can and can’t claim
Today, I was reminded about the special regulations required for dietary supplements. It occurred when an Amazon representative called me to tell me that one word describing my sleep formula supplement implied it was for a disease.
That word was “aid,” as in the term “sleep aid,” which was on the description page. That wording implies it treats the disease of “insomnia.”
In the United States, supplements are not allowed to state such things. So, my product was removed from Amazon for several days until I reworded the description.
According to the Food and Drug Administration regulations and policies, food and dietary supplements are only allowed to make “structure or function” claims.
The FDA says, “Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, ‘calcium builds strong bones.’
“In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, ‘fiber maintains bowel regularity,’ or ‘antioxidants maintain cell integrity.’
Health-related claims, however, are no longer allowed, though they used to be. No one goes to jail for making such a claim, but they may get a warning letter, fined if they don’t oblige, or potentially shut down.
The FDA’s job is to approve a drug for a specific indication [by evaluating studies of the drug’s safety and effectiveness. Congress does not allow the FDA to evaluate the safety or effectiveness of supplements before they are sold].
From now on, consider how supplement makers have to talk to you. It’s only with structure/function claims. If they claim their product treats a disease, that tells you they don’t know what they’re doing, or that they’re intentionally trying to fluff up their product to make a sale.
Here are some examples of what supplements are not allowed to claim:
—These pills relieve the pain of osteoarthritis and tendonitis.
That statement is not allowed because arthritis is a disease name, and only drugs treat it. If a drug like Celebrex makes this claim, it’s totally okay because their medication is effective for those diseases, and the clinical trials prove it. But someone selling an herbal supplement cannot say it.
Instead, supplement sellers could say their product “supports healthy joints, cartilage and tendons.”
—Vitamin D can help with respiratory infections or Hashimoto’s thyroiditis.
Bad. Very bad, unless of course you are trying to sell a drug for those disorders. But sellers can say, “Vitamin D supports healthy immune function, as well as strong bones and teeth.”
—Such and such pills are for diabetes.
Nope! Diabetes is a disease, and as such only drugs like metformin or insulin can be marketed to help it. A supplement formula — no matter how good it is — could never make that claim under the law.
Instead, we’d state that our formula “supports a healthy pancreas,” hoping you’d understand it’s meant for those with diabetes.
See how it works now? Supplement makers are muzzled. It’s intended for your protection, but in my opinion, it can also confuse you and cause you to take supplements that won’t help (and might hurt) because you don’t know what they’re really intended for!
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This information is opinion only. It is not intended to treat, cure or diagnose your condition. Consult with your doctor before using any new drug or supplement.
Suzy Cohen is a registered pharmacist and author of The 24-Hour Pharmacist and Real Solutions from Head to Toe.