When a company markets a product as a “dietary supplement”, rather than as a drug, the FDA has little input into the production or quality of the product, nor does the FDA assess the safety or effectiveness of the supplement. This has allowed the deceitful marketing in health food stores and supermarkets of products with unfounded claims and unproven safety. On March 4, 2008, I detailed in this GERMBlog the story of a product called “Airborne”, a fizzy drink marketed to kids and adults as a “miracle cold buster”. As a result of a class action lawsuit (prompted by an investigation by ABC News), the company paid a lot of money to deceived customers and pulled all reference to “miracle”, “cold”, and “buster” from their packaging. Yesterday, the company that manufacturers the zinc-containing “Zicam” product line pulled a number of its products from the marketplace because of more than 130 complaints, compiled by the FDA, of long-term or permanent loss of the sense of smell. The manufacturers, while withdrawing the products, insisted they were safe.
Herbal products (dietary supplements) that purport to “boost” your immunity and “prevent” or “treat” infections like the common cold are plentiful. In researching my book, Germ Proof Your Kids – The Complete Guide to Protecting (without Overprotecting) Your Family from Infections (ASM Press, Washington, D.C., 2008), I went to the health food stores and found more than 2 dozen such products! I discuss each, along with the scientific data (or lack therof) to support their claims in Chapter 10 of Germ Proof. Zinc products receive heavy scrutiny in Germ Proof Your Kids, and without wanting to say “I told you so”, I reported the complaints regarding loss of the sense of smell, as well as the even more concerning news (at least it’s news affecting many more than 130 users of Zicam) that zinc products have not been convincingly shown to work against the cold, especially in kids. Because FDA approval isn’t required for marketing dietary supplements, the studies showing effectiveness, if done at all, are often far less rigorous than studies for FDA-approved drugs.
To bring a dietary supplement to the shelves of your health food store, a company doesn’t have to prove the safety or effectiveness of the product, and doesn’t even have to prove that the product in the bottle is what’s shown on the label. The company doesn’t have to keep track of side effects. In lieu of all of that stringency that the FDA applies to registered drugs, the FDA only requires that dietary supplements bear a tepid disclaimer. When you see the words below, buyer beware – the product has not been rigorously proven to be safe or effective. Both “Airborne” and “Zicam” bore this disclaimer:
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”.