Posted with permission from Fairwarning.org:

When the federal government examines widely sold dietary supplements and finds that they are falsely labeled, shouldn’t consumers be warned?

That’s an issue some critics are raising following a recent evaluation by the Government Accountability Office of three leading dietary supplements marketed as memory boosters.

In its report released last month, the GAO said two of the three products were mislabeled but wouldn’t name them or their manufacturers. The watchdog agency said a testing lab it hired found that one of the products contained none of its promised ginkgo biloba, and the second had less of the substance than the label indicated. In both cases, the GAO reported, the products were adulterated with unknown substitute ingredients used instead of ginkgo biloba, a relatively expensive herbal extract from the leaves of the ginkgo tree.
 

Although ginkgo biloba is advertised as increasing mental sharpness and aimed at elderly consumers who want to stave off memory loss and dementia, a large federally funded study in 2009 discovered no such benefits. Nonetheless, dietary supplement companies keep promoting it to pump up sales. The recent GAO evaluation checked only for ingredients and didn’t try to gauge effectiveness. The third product in the GAO study, a fish oil supplement, was found to actually exceed the ingredient amounts stated on the label.

The agency said it referred its findings on the two adulterated products to the

U.S. Food and Drug Administration “for review and a possible investigation.”

But the failure to name the products — which were chosen because they are among the nation’s most widely advertised supplements and sold by major retailers – was criticized as a missed opportunity to alert millions of people.

“Consumers should be informed so that they know that they’re being defrauded,” said Laura MacCleery, policy director for the Center for Science in the Public Interest, a nonprofit watchdog group.

Or, as Dr. Pieter Cohen, an associate professor at the Harvard Medical School who has studied supplements, put it: “Taxpayers should know what was found … We’re paying for it.”

An executive for a leading dietary supplement trade group, the Council for Responsible Nutrition, also expressed support for disclosing the information – arguing, in part, that the industry should have a chance to review, and possibly challenge, the government’s research. Duffy MacKay, the council’s senior vice president for scientific and regulatory affairs, said his industry has “punched back” in the past against flawed scientific research. “Our organization has really embraced the concept of transparency,” he said.

Holly Johnson, the chief science officer of another trade group, the American Herbal Products Association, also raised questions about the GAO research. “No test methods or data were released, so it is impossible to ascertain if the test methods used were scientifically valid and fit for purpose for those 2 finished products,” Johnson said in an email.

Johnson added that even if ”the work is credible … testing only 3 products does not provide evidence of anything from a market perspective.”
 

The lack of disclosure about the tested products is a particular sore spot among consumer advocates because dietary supplements get less regulatory scrutiny than prescription drugs or medical devices. Under the 1994 federal law regulating supplements, the substances don’t need approval before being marketed.

Meanwhile, sales have ballooned to an estimated $45.8 billion this year, and the number of supplement products has surged from 4,000 in 1994 to 80,000 as of the most recent federal estimate. The FDA, which regulates supplement manufacturing and labeling and teams with the Federal Trade Commission on marketing issues, handles those duties through its 26-employee Office of Dietary Supplement Programs. Critics call it a passive regulator, pursuing potential problems only after complaints are lodged.

The FDA said it took 145 enforcement actions involving dietary supplements in fiscal 2017, including issuing 70 warning letters and putting on hold 69 shipments of imported products.

“The market is flooded with bad actors,” said Dr. Michael Carome, who heads the health research group of Public Citizen, a consumer advocacy group. There are so many products on the market, he said, regulators “just can’t keep up.”

MacCleery, of the Center for Science in the Public Interest, agreed. She said FDA officials sometimes don’t go after the makers of supplements “that are just fraudulent,” because they want to focus on sellers of supplements that are illegally laced with amphetamines or other potentially dangerous drugs. “So this is a missed opportunity because the GAO could have told consumers what it found,” MacCleery said.

When asked why the GAO isn’t naming the supplements it recently tested, Chuck Young, the agency’s managing director for public affairs, said via email: “The bottom line is we don’t have enforcement powers so we do the responsible thing and turn the information over to those who do have such authority. “

“We’re focused on government performance so when we find issues in the private sector, it’s general policy and practice not to name specific products, companies, locations, etc. in public reports,” Young said. “That can compromise the efforts of those agencies who do have enforcement power.”

The FDA, which has begun reviewing the GAO report, also refused to name the products. “As a policy, the agency doesn’t comment on ongoing investigations,” the FDA said.

Apart from the issue of mislabeling, consumer advocates sharply disagree with industry officials on the merits of ginkgo biloba as a memory booster. In May, the Center for Science in the Public Interest urged consumers to avoid supplements made with ginkgo biloba, saying they often are adulterated and “have largely been shown to be ineffective in improving memory and circulation.”
 

Cohen, of the Harvard medical school, expressed frustration about companies that spend heavily to advertise such products even though they lack proven benefits. “There’s no known ingredient supplement that I know about that can improve your memory, but that doesn’t stop companies from legally advertising their supplements as if they work for improving brain function, for improving your memory,” he said. “That’s one of the problems with the law, is that claims are completely separated from the evidence … and manufacturers are protected for making these statements even when there’s no evidence to support them in human trials.”

But MacKay from the Council for Responsible Nutrition brushed aside the criticism. “These are dietary supplements, these are not drugs,” he said. “They’re not intended to treat or cure diseases. Ginkgo’s been traditionally used for thousands of years as a product to enhance circulation, and American consumers want to continue those botanical traditions.”

“I think,” he added, “these are quality botanical products that have a place.”

About FairWarning

This story was reported by FairWarning (www.fairwarning.org), a nonprofit news organization based in Pasadena, Calif., that focuses on public health, safety and environmental issues.