Thursday, November 01, 2012

What's the real take-home message of a new, negative Department of Health and Human Services report regarding dietary supplements?

By James J. Gormley

On October 2nd, 2012, Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS), issued two reports regarding dietary supplements.

The first report, regarded as the more serious of the two, entitled “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” captured immediate public attention and could have, say some, lasting negative impact on the dietary supplement industry. But are the report’s allegations true ... or fair?

The Report: What Does It Say Its Says?
With its first report on structure-function claims, HHS purported to assess industry compliance with structure-function claim requirements. As such, 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 alleged problems, the HHS report said that 20 percent of the products displayed prohibited disease claims.

As to what stimulated the HHS OIG to conduct the review, the structure-function report’s preamble only states that the investigation was a response to inquiries from both the Government Accountability Office (GAO) and “public interest groups.”

A Cherry-Picked Sample?
A number of industry organizations and consumer advocates challenged whether such a small sampling of products could be regarded as representative of the dietary supplement industry at large, including the industry’s many responsible companies.

As Washington, D.C.-based Natural Products Association (NPA) executive director and CEO John Shaw, said in an an interview with me for Nutritional Outlook magazine, “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 expressed concern regarding the OIG’s sampling methods, expressing doubt that 20 percent of randomly chosen products would have had disease claims.

Justin J. Prochnow, a Denver-based attorney with Greenberg Traurig, discussed the sampling question. “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 noted. In addition, industry members criticized the HHS 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 percent [of questionable products],” said Steve Mister, president and CEO of the Washington, DC-based Council for Responsible Nutrition in an interview with me for Nutritional Outlook. “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.”

In an attempt to tackle this question, on behalf of Nutritional Outlook magazine I submitted a Freedom of Information Act (FOIA) request to the IG’s office asking them to reveal the names and manufacturers of the products with questionable claims, in addition to information on what websites the products were purchased from.

In addition, 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?” Mister said. “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.”

What Does It Really Say
Since Inspectors General (regardless of department of agency) are almost always charged with primarily investigating internal fraud, waste, abuse and mis-management, what did the IG find regarding how the FDA manages dietary supplements?

When the FDA was asked by the IG to produce substantiation documents that had been previously submitted by companies, the FDA had no idea where to find them and, indeed, had no system in place to record, archive, track and retrieve submission documents that its own regulations require!

Here’s what the IG wrote:
“FDA could retrieve notification letters for only 21 of 127 supplements in our sample. FDA’s failure to locate notification letters raises questions about its ability to adequately monitor and enforce manufacturers’ compliance with structure/function claim requirements” [emphasis mine].
In addition, as mentioned above, the IG wrote that the FDA “lacks a reliable tracking system for notification letters.” The report said:
“FDA saves letters in a PDF format that cannot be searched by keyword. As a result, FDA could not locate letters for our sampled supplements using the product name or the manufacturer’s name. As of December 2011, FDA staff told us the agency had letters waiting to be scanned that dated back almost a year. FDA files the paper copies of notification letters chronologically. Therefore, FDA would have had to search thousands of files by hand to locate letters for our sample of supplements” [emphasis mine].
So, as the saying goes, the elephant in the room was the obviously horrible mismanagement and disorganization (perhaps incompetence) of an agency, in this case the FDA, an agency that the IG is suggesting be given even more power and responsibility over supplements despite the fact that the agency has proven that it cannot even handle the most basic of its existing responsibilities. This serious indictment of the FDA was half-buried in the report itself and completely ignored by the mainstream media.

Future Effects?
Despite the serious flaws in the report, to the average consumer the HHS reports have the potential to paint the broad supplements industry in a bad light, indeed. The media was quick to gravitate to this. Among the alarmist headlines following the reports’ release: 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 (, “Dietary supplements often lack reliable evidence to support health claims.”

As largely unimportant as the report might seem since it is a small study with limited applicability and potentially flawed, both industry and consumer groups view it as likely ammo the dietary supplement industry’s foes in Congress could try to use in support of efforts to expand FDA’s authority over dietary supplements, which we’ve shown would be disastrous for several reasons.

“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,’” added Mister. He noted, “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 speculated how the FDA might use the first 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,” he said.

“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,” added Gretchen DuBeau from the Washington, DC-based Alliance for Natural Health.

DuBeau summed it up in 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: The Gormley Files is very grateful to Nutritional Outlook magazine for permitting some text from the upcoming November 2012 "Global Regulations" story to be adapted for use here.
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