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Will a new, negative Department of Health and Human Services report follow the dietary supplements industry for years?
On October 2, Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services (HHS), issued two troubling reports regarding dietary supplements. The first report, considered to be the more serious of the two, is titled “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements.”
(The second HHS report, titled “Dietary Supplements: Companies May Be Difficult to Locate in an Emergency,” found that some companies do not list proper contact information on labels. While alarming, this report generated less response than the structure-function claims report, and so I will not discuss it in this article.)
The structure-function claims report sparked immediate public attention and could have lasting negative impact on the dietary supplements industry, some posit. But are the report’s allegations true-or fair?
In the report on structure-function claims, HHS purports to assess industry compliance with structure-function claim requirements. To do so, the report states, HHS’s Office of the Inspector General (OIG) purchased 127 dietary supplement products-specifically immune-support and weight-loss supplements-on the open market to examine their structure-function claims. In total, OIG purchased 67 immune-support supplements and 60 weight-loss supplements, 67 of which were from Internet sites and 60 of which were from retail stores. Aside from other putative problems, the HHS report says, 20% of the products carried prohibited disease claims.
As to what stimulated the HHS OIG to conduct the review, the report’s preamble only states that the investigation was a response to inquiries from both the Government Accountability Office (GAO) and “public interest groups.”
Some industry organizations and consumer advocates question whether such a small sampling of products could be considered representative of the dietary supplements industry at large.
As Natural Products Association (NPA; Washington, DC) executive director and CEO John Shaw, states, “The OIG only checked 127 supplements out of more than 29,000 on the market. The report itself says that the results cannot be generalized across the entire industry. Therefore, a small sampling of supplements should not be used as a smear against a legitimate industry that cares about the safety and health of consumers.”
Others question OIG’s sampling methods, expressing doubt that 20% of randomly chosen products would have had disease claims.
Justin J. Prochnow, an attorney with Greenberg Traurig (Denver, CO), comments on the sampling question specifically. “My inclination would be to believe that the majority of the products cited in the report said to be marketed with alleged disease claims were being marketed online from websites without an established reputation. It has been my experience that ‘brick and mortar’ stores, as well as reputable online stores, are putting products through a pretty comprehensive label and claims review process before allowing them to be sold.”
“I would be very surprised if many of the products used as the basis for the report were purchased at well-known stores or from reputable online retailers,” he adds.
Moreover, industry members criticize the report for intentionally not identifying the questionable products.
“They don’t identify the companies, so you don’t know which ones were in the 20% [of questionable products],” says Steve Mister, president and CEO of the association the Council for Responsible Nutrition (CRN; Washington DC). “You don’t know if they were all fringe companies on the edges of the Internet that maybe collectively had sales of a million dollars, and whether everybody else-the ones that got it right-were the NBTYs and the Pharmavites.”
And finally, some take issue with the fact that the OIG’s office asked companies to voluntarily send substantiation data, but then in the reports criticized the submissions for not also containing negative data-a criticism that Mister dismisses.
“If the OIG wrote to me in a voluntary survey and asked for my substantiation, why would I ever send them anything that was negative?” he says. “Even if I had [negative substantiation] and I gave it to FDA, why would I send it to the OIG? I wouldn’t. However, the OIG says, ‘Well, you didn’t meet all of [our] criteria because you didn’t disclose studies that went the other way.’ But did OIG ask those companies to do so? No. Instead, OIG said, ‘Send us your substantiation for your product,’ so naturally a company is only going to send OIG the substantiation that’s supportive.”
Despite these important flaws, as far as the lay consumer is concerned the HHS report paints the broader supplements industry in a bad light indeed-a point that the media quickly picked up. Among the alarmist headlines were Huffington Post’s “Dietary Supplements Illegally Labeled: Dozens Make False Claims, Report Says;” CBS News’ “Study: Some Dietary Supplement Labels Illegal;” and from that most balanced of news sources, the American Medical Association (AMedNews.com), “Dietary Supplements Often Lack Reliable Evidence to Support Health Claims.”
As insignificant as the report might seem, both industry and consumer groups see it as future ammunition that the dietary supplement industry’s foes in Congress could attempt to use in support of efforts to expand FDA’s authority over dietary supplements.
“I’m particularly concerned about [one] recommendation [in particular], because I think this is the most damning line in the report, which says, ‘FDA could seek legislation requiring approval for all structure-function claims in the labeling of dietary supplements,’” says Mister. He adds, “I don’t think FDA has a right to do that under the law, and certainly even if it had a right to do that under the Constitution, obviously [the dietary supplements industry] would fight that tooth and nail in Congress.”
Mister says he wonders how the FDA might use the report for a longer-term plan that might include the revocation of some, or many, structure-function claims, with the agency reasoning, “Well, you know what? These have really become de facto disease claims.”
As for this use of HHS power, “This dubious document, which we believe will serve as an advocacy [tool] for greater FDA regulation of free speech, is a far cry from the OIG’s stated mission, which is to audit and investigate HHS programs to prevent and detect fraud and abuse,” says Gretchen DuBeau from the Alliance for Natural Health (Washington, DC).
DuBeau sums it up this way: “FDA chooses not to provide or improve guidance for the industry. [When] a few bad apples exploit the regulatory uncertainty, those bad apples are then used by advocacy groups and members of Congress to reduce our access to all supplements.”
Editor’s Note: Nutritional Outlook submitted a Freedom of Information Act request to the OIG in the hopes of obtaining, 1) the product names and manufacturers of the 26 allegedly violative products, 2) the name of the website or store from which each product was purchased, and 3) the names of the public interest groups that asked HHS to conduct this review. We will keep readers apprised of any response received.