A recent warning letter issued by the Food and Drug Administration to a company known Northern Health Products lays bare an Achilles heel of the dietary supplement industry. Some marketers use the industry as a platform to sell noncompliant products with apparently little in the way of risk.
In the warning letter FDA takes the company to task for selling several products that amount to an unapproved new drugs. The most prominent of these is called DCA Cancer Kit, which contains a bottle of sodium dichloroacetate (DCA) tablets and another of a thiamine supplement. The products are sold with a supplements facts panel but no DSHEA disclaimer. The company was not plucking an indication out of the air; DCA has been studied as a potential cancer treatment since at least 2007. Recent studies have looked into the compound’s effects in cases of colon cancer and leukemia. But even with a halo of clinical evidence surrounding the compound, Northern Health Products’ marketing of it matches no regulatory category.
“The easy answer is that this does not comply with DSHEA. Saying ‘Cancer treatment’ is about as blatant a violation as I can imagine,” said attorney Ivan Wasserman, who manages the Washington DC office of the firm Amin Talati Upadhye.
“On the label of these products it does say ‘for professional use only.’ They may be intending for the product to be used under medical supervision, but that does not in any way impact the claims that can by made on a dietary supplement,” Wasserman told NutraIngredients-USA.
Among the claims that the company made for the product are: “DCA can be an effective tool in shrinking tumor size and mass, reversing illness, and increasing health and vitality of patients.” According to FDA, the company has also made noncompliant claims on products containing alpha lipoic acid and N-acetyl L-cysteine.
Durable feature of market
Wasserman said that while cancer claims have abated somewhat. But with the ease of market entry that the Internet has afforded—something that is only likely to increase—they are unlikely to go away any time soon.
“Certainly over the years the number of companies being cited in FDA warning letters for making cancer treatment claims does appear to have diminished, but they are still there,” Wasserman said.
Critics of the industry cite the market structure created by DSHEA as making this kind of violation all too easy. But Wasserman said he’s unsure whether a different setup, such as requiring pre-market approval, would make much difference in cases like this.
“Is is the way DSHEA is set up? Or is it the lack of enforcement resources combined with the ease of entry to the market created by the Internet? If DSHEA were set up to require premarket approval for products like this who’s to say that companies would still comply?” Wasserman asked.
Wasserman said that one usual aspect dietary supplement industry as compared to other market sectors is that it continues to attract neophytes who are either unsophisticated or willfully ignorant.
“There is part of the dietary supplement industry that understands the law and follows the law and seeks appropriate council. Then there is a part that understand the law and chooses to not follow the law. And there is part of the industry that still does not understand the law. I still to this day receive calls from companies that do not understand many of DSHEA’s basic provisions,” Wasserman said.
Northern Health Products declined to comment for this report.