That fact was borne out recently with two warning letters to online marketers of dietary supplements. One letter was sent to an online retailer named Health Research Laboratories and the other to a marketing firm called Golden Pride, Inc. In both cases, the firms were marketers of a wide range of dietary supplements which the agency took to task for unauthorized disease claims.
That one letter came on the other’s heels in October doesn’t necessarily mean a change in FDA’s priorities or a ramp up in this area of enforcement, said Justin Prochnow, an attorney with the firm Greenberg Traurig. Rather, it is something that FDA has been focused on for a while, he said.
“Certainly the products sold online are the subject to the same requirements as those sold in stores. The products sold online might be even more reviewed that those that are sold in stores,” Prochnow told NutraIngredients-USA.
Disease claims, labeling issues
In the two letters FDA took the companies to task for both unapproved drug claims and labeling errors resulting in products being deemed as adulterated. In the letter to Golden Pride, FDA said the company’s products were classified as unapproved new drugs because they were being promoted for the cure or prevention of diseases. The claims included language such as “reduce the risk of heart disease and lower cholesterol levels,” “benefits include providing antibacterial, antiviral, and antifungal properties while aiding in the prevention of heart disease” and numerous others. Making claims for uses for which products are not considered generally safe and effective makes them unapproved drugs. FDA also took the company to task for not adhering to the approved language in making a heart health claim for one of its supplements that contained plant sterols.
Similarly, the website of Health Research Laboraties was liberally littered with unapproved disease treatment claims, according to the warning letter. Claims included “combats certain degenerative diseases such as Parkinson’s, Alzheimer’s and Huntington’s,” “can give relief from pancreatic conditions such as diabetes and hyperglycemia” and “days free from the pain of rheumatism, osteoarthritis and general joint aches.” FDA also cited the company for the inclusion on its website of a letter purportedly written by a medical doctor that promoted the company’s products for disease conditions.
A tool that cuts both ways
Prochnow said that while it’s easy to put up information on the Internet and rapidly alter it, it also makes it easier for FDA to find, too.
“It is much more common for FDA to be reviewing online information on websites that it is for them to be walking into your neighborhood GNC to check labels,” Prochnow said. “When I talk to companies about claims I talk about labels and websites, and not necessarily in that order.” The rapid turnover for companies is a challenge for FDA, Prochnow said. While it is vastly more efficient in terms of man hours to review websites from a central location, the low barrier to entry means there are that many more websites to review.
“FDA can just do a search such as ‘supplements and cancer’ and see what pops up. It certainly is easier for a company to pop up qauickly on the Internet. You can start doing business with less red tape and FDA knows that. You are always going to have peopel tryingi to take advantage o fthe system regardless of what the medium or the form is,” Prochnow said.