Economic Adulteration Underscored In GAO Memory Supplements Study

Audit finds two of three memory supplements tested contain none or lower levels of active supplement than stated on labeling. In a report for current and previous  ranking minority members of Senate Special Committee on Aging, GAO points to continuing issues with economic adulteration for gingko biloba.

A Government Accountability Office report that found two of three memory supplements tested did not contain ginkgo biloba or other ingredients listed on labels is likely to bring fresh scrutiny to the booming segment already in the Federal Trade Commission's crosshairs.

The auditing and investigative arm of Congress on Nov. 14 published the findings it stated in a report to Sens. Claire McCaskill, D-MO, ranking member of the Senate Committee on Homeland Security and Governmental Affairs and Bob Casey, D-PA, ranking member of the Special Committee on Aging. Copies also submitted to FTC and FDA.

GAO contracted with a lab to determine whether three unidentified but “highly advertised” memory supplements contained the stated ingredients in quantities identified on labels and whether they contained certain contaminants.

Tests of the multi-ingredient memory supplement identified about half the amount of ginkgo flavanol glycosides as stated on the label and phosphatidylserine was a lower amount. The formula contained no ashwagandha, contrary to the label claim. – GAO

The report does not identify the manufacturers or marketers of the tested products and offered few details on the amounts or identities of substances in the products that rendered them adulterated.

Natural Products Association CEO Daniel Fabricant urged GAO to release the names of any contaminated or mislabeled products and for FDA “take all appropriate legal action” to protect consumers. “The FDA and the FTC have strong enforcement authority to protect consumers from dangerous products,” Fabricant said in a statement.

A single-ingredient gingko biloba product was found to contain none of the ingredient but to be adulterated with one or more substitute ingredients, according to a report GAO submitted to the senators on Oct. 18. A supplement labeled as a cognitive benefit product contained less of at least two of three ingredients claimed on is label and was adulterated with ingredients substituted for ginkgo biloba.

A third product – a fish oil – contained all stated ingredients at quantities above the label amounts.

“We will refer these products and the results of our testing to FDA for review and possible investigation, in coordination with FTC as appropriate,” the GAO report said.  FDA and FTC did not submit comments about the findings to GAO.

Misleading cognitive benefit claims, especially targeting the elderly, have been and will continue to be a top priority for FTC enforcement, a commission advertising practices official said at a consumer health industry conference in 2017. (Also see "Supplement Claims Targeting Elderly, Weight Conscious Top FTC Priorities" - HBW Insight, 24 May, 2017.)

McCaskill, who lost her seat in the Nov. 8 mid-term elections to Republican Josh Hawley, made a priority of enforcement against supplement companies that allegedly exploit the elderly when she previously served as ranking member of the Special Committee on Aging. In 2015, she asked retailers to stop selling supplements containing picamilon, an ingredient frequently promoted to improve cognitive function. FDA sent warning letters to marketers of products containing the ingredient. (Also see "Sports Nutrition Products Mark Start Of FDA’s Picamilon Enforcement" - Pink Sheet, 7 Dec, 2015.)

Ginkgo, Ashwagandha Missing

GAO says the senators asked for the tests due to sales growth of the category, which nearly doubled from 2006 to $643m in 2015, and a trend of consumers seeking natural treatments for memory issues related to aging or neurological conditions, such as Alzheimer’s disease.

A reported 500 memory supplements were available in the US in 2016; the segment accounted for nearly 2% of the entire supplement market in 2015, with fish oil sales of $250m and ginkgo biloba sales of $78m, according to GAO's report.

The internet is further compounding concerns about memory supplements and claims, the agency office said. In a 2017 review on memory supplement marketing, GAO found 96% of advertising was online and suggested FDA and the FTC provide further guidance related to their oversight of online supplement marketing. GAO also said FDA faces “oversight challenges” with memory supplements due to a lack of understanding on ingredients and products currently for sale. (Also see "GAO Report Casts Shade On Sunscreen Ingredients' Chances With FDA" - HBW Insight, 20 Nov, 2017.)

The latest report aimed to shed light on the accuracy of product labels. The entire GAO audit included the 2017 and latest reports and ran from May 2017 through October 2018. GAO contracted with a “qualified and vetted” lab to test three supplement products, which it described as “nong-eneralizable sample selected from a list of highly advertised” supplements identified in its 2017 report.

GAO picked three of the 10 most-advertised items based on the popularity of their main ingredient, the number of ingredients and availability in major retailers; products were purchased online and in retail stores; a different firm produced each of the supplements.

The lab tested two samples each of the ginkgo biloba and the specialty memory supplements and three samples of the fish oil product. The tests included ingredient identity and quantity testing for selected ingredients on labels.

Testing found the ginkgo biloba product, which claimed to contain 120mg in each serving, did not identify as ginkgo but was intentionally adulterated with one or more substitute ingredients.

Tests of the multi-ingredient memory supplement identified about half the amount of ginkgo flavanol glycosides as stated on the label and phosphatidylserine was a lower amount. The formula contained no ashwagandha, contrary to the label claim.

The fish oil product contained 8% to 13% higher levels of omega-3 fatty acid than stated on the label because manufacturers account for potency deterioration over a product’s shelf life, GAO noted.

The investigation also looked for “dangerous” contaminants arsenic, cadmium, chromium, lead and mercury, the report says. Trace amounts of contaminants were found in the supplements, “but at levels considered safe.".

Remnants Of Economic Adulteration's Heyday?

The small number of products tested diminishes the audit's impact, says Duffy MacKay, senior vice president, scientific and regulatory affairs for the Council for Responsible Nutrition. In an interview, he said he “hesitates to make too much” of the findings.

However, he said the gingko biloba product containing different substances than labeled is a serious issue and likely can be attributed to economic adulteration, which is “unacceptable and is something our industry is actively trying to address.”

Economic adulteration occurs when a supplier of an expensive ingredients such as ginkgo biloba decides, without informing its manufacturing customers, to substitute a cheaper substance. Manufacturers’ lab tests often cannot differentiate between ginkgo and a cheaper substitute, MacKay said.

Ginkgo biloba in particular has been switched for substitutes in the supply chain, but the industry has made progress in the past three to four years in weeding out bad products and, said MacKay. The ginkgo supplement investigated in the study could have been among the “flurry of fake material floating around” during the worst of adulteration, he said.

However, ginkgo was the subject of controversy earlier this year. Nutrition and food safety watchdog group The Center for Science in the Public Interest in May suggested FDA enforce against marketers of ginkgo biloba supplements after ConsumerLab.com found six of 10 supplements it tested contained either less of the herb than advertised or different and cheaper plant material. CSPI said FDA “should act” on ginkgo supplements “since the evidence of intentional adulteration in US-sold products is clear. (Also see "Gingko Supplement Adulteration Points To Broader Problem For FDA – CSPI" - HBW Insight, 15 May, 2018.)

GAO also acknowledges ginkgo adulteration, but says it is a difficult problem to fix “because of the complicated supply chain and lack of expertise in methods that effectively detect the adulteration.” For example, "supply chains for supplements can be complex, with ingredients sold and resold by multiple suppliers before making it to the final product and it can be difficult to track the source of an adulterated ingredient.”

It adds that even though FDA’s current good manufacturing practice regulations require firms to conduct ingredient identity and purity testing, “in practice, testing is sometimes conducted in such a way that it would not catch the adulteration.”