FDA Accuses Supplement Manufacturers of…Selling Drugs?

Misleading claims vs. legitimate science—getting to the truth can be a minefield! Which is why the Free Speech about Science Act is so important.


The US Food and Drug Administration recently sent warning letters to manufacturers of a number of products—MedaVir, Herpaflor, Viruxo Anti-Viral Support, C-Cure, and Never an Outbreak—for making health claims about treating or preventing sexually transmitted diseases, including herpes.

According to the FDA press release, “While some of the companies market these products as dietary supplements, these products are all drug products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are offered for the treatment of disease. These drug products, which are offered for the treatment of STDs, may not be introduced into interstate commerce without an FDA-approved new drug application (NDA).”

On their websites, the supplement manufacturers make a wide variety of claims. Some of the claims are supported by varying degrees of science; some seem wildly overreaching. But all health- or disease-related claims are currently illegal. And that is precisely the problem: there is no mechanism in place for citing the legitimate science behind a food or supplement’s effectiveness. Many Americans are trying to take charge of their health, and they are desperate for information, so some supplement manufacturers are filling that void by violating current law and making health claims—which makes it even more difficult for consumers to judge a misleading claim from a scientifically valid one.

MedaVir’s website says that research about the product’s ingredients effectiveness has been published in national medical journals, though they don’t link to that research. The website also says MedaVir has been proven effective by an official FDA phase 2 double-blind clinical trial, as well as research at Proctor and Gamble’s laboratories for medical testing and the Cincinnati Children’s Hospital Infectious Diseases Division. Why would FDA warn a manufacturer over health claims when a FDA clinical trial has proven that the product is effective?

Here’s why. The sad truth is, whether the products are effective or not, or whether they have good science to back up their claims or not, is utterly irrelevant to the FDA. Dietary supplements cannot treat or prevent STDs like herpes—only FDA-approved, prescription-only medications can do that. That’s because, as you’ll note above in the FDA’s own words, any product that is offered as a treatment for disease is by definition a “drug product,” and without an NDA, said drug product cannot be sold.

Sadder still, natural substances can be powerful healers, but most of the public will never hear about them. As we have reported in previous newsletters, there are excellent natural treatments for diseases like herpes: vitamin C, selenium, lysine, and especially the powerhouse of the vitamin world, vitamin D. But the FDA says that making a health or disease claim for a supplement instantly and magically transforms it into a drug. It must therefore go through the FDA drug approval process or it cannot be sold. Alternatively, it can be sold, but you can’t tell anyone about its health benefits!

The difficulty, as we have noted many times, is that naturally occurring substances cannot be patented, and without patent protection, few manufacturers will pay the millions—and occasionally billions—of dollars to do the double-blind studies necessary to bring a new product through the FDA new drug approval process.

The long and short of it is this: the current health claim regulation system is broken, and the FDA is exploiting it.

This is why we so desperately need the Free Speech about Science Act of 2011 (FSAS). Passing this bill into law would make a food’s or product’s scientific studies and their implications more transparent and understandable to consumers.

Under FSAS, dietary supplement manufacturers will be able to make well-substantiated disease or health-related claims, based on legitimate scientific research. Because food and supplement manufacturers cannot legally make health claims, it becomes even harder for consumers to make informed and healthy decisions—and consumers are missing out on valuable information. FSAS creates a standard that would weed out junk science and misleading claims, and would provide health-conscious consumers with access to much-needed credible scientific information behind natural products.

We mentioned MedaVir earlier, but some of the other companies targeted by the FDA warning letter also cite scientific evidence to support their claims. The Herpaflor website, for example, cited science behind each of the product’s seventeen different ingredients (or did, before the FDA warning letter made them remove the citations, though we have a PDF of the page in question), supporting the claim that Herpaflor’s ingredients help prevent and treat herpes outbreaks as well as help alleviate some of the side effects such as pain and discomfort. They listed twenty reputable scientific sources for their claims, ranging from NIH studies, The Journal of Dermatology Treatment, The Journal of Medical Sciences Research, and The Journal of Antimicrobial Chemotherapy—though they also listed a number of sources that are not peer-reviewed, like BBC News and Answers.com.

ANH-USA does not, of course, support manufacturers’ misleading or fraudulent claims! We do support, however, the right of consumers to have access to credible, peer-reviewed scientific information about food and dietary supplements. It is difficult for consumers to differentiate what is credible information and what isn’t—because there is no standard in place for citing science for natural products. FSAS would help correct this.

The great irony here is that FDA and FTC absolutely allow egregiously misleading claims—with impunity—so long as they’re made by the major pharmaceutical manufacturers! For example, a full page ad for Astrazenica’s acid blocker drug Prilosec OTC in People magazine says in large type, ZERO HEARTBURN**. If you follow the asterisks down to the bottom of the page, it says in tiny type, “It’s possible while taking Prilosec OTC.” So the actual message is that zero heartburn is possible while taking this drug. Of course, zero heartburn is possible for any other product under the sun! Manufacturers of acid blockers are very careful to avoid saying that their product cures heartburn—because there is no evidence it does. There is abundant evidence, however, that it leads to more infection, pneumonia, bone problems, and a failure to absorb minerals. There is also evidence that it actually makes heartburn worse over time. Yet the FDA and FTC have no trouble with these claims.

Consumers have the right to access this information, and the FDA’s method of barring access to this information in untenable. There must be a system that allows consumers access to credible scientific data, through legislation like FSAS. If you have not already done so, please see our Action Alert and ask Congress to support the Free Speech about Science Act!