CVS launches a dietary supplement testing program

Over the last 25 years, the food supplement market has exploded, with revenues estimated at $ 42 billion last year, up from $ 4 billion in 1994. This growth can be attributed in part to a federal law pbaded this year that has relaxed the regulation of the sector. .

Known as the Dietary Supplement Health Education Act, this law allows the sale of supplements (vitamins, minerals, herbs, etc.) in supermarkets without the prior approval of the US Food and Drug Administration. The FDA may take action by sending warning letters to the public or recalling items if they determine, through a product sampling, that a supplement has been falsified. But the agency only intervenes after the product has been on the market and after consumers have reported adverse events. According to a 2015 study, supplements would be responsible for approximately 23,000 trips per year in emergency rooms (N. Engl. J. Med. 2015, DOI: 10.1056 / nejmsa1504267). According to a spokesman for the FDA, "manufacturers and distributors of food supplements are responsible for the safety and legality of their products."

For the first time, the CVS retailer submits the supplements to an independent evaluation. Their program, "Tested to be Safe", requires manufacturers and distributors of food supplements to submit their products for testing by third parties before the company offers supplements in their stores or online. CVS announced the program for the first time in 2017 and has since completed testing of 1,400 supplements from more than 150 suppliers. The retailer plans to test new products as they appear.

The tests do not evaluate any claim related to the health of the product. Instead, the tests confirm the identity and quantities of the active ingredients in the additional label. The products are also tested for contaminants such as heavy metals, yeast, molds, pesticides, biological pathogens and industrial compounds such as polychlorinated biphenyls.

According to a CVS press release, 7% of initially tested products failed and were removed from CVS stores or their labels were updated. Although the supplements failed for several reasons, including contamination, most cases involved amounts of active ingredients below the levels indicated on the label, says Mike Harvey of NSF International, a third-party laboratory that CVS was responsible for performing the tests. with Eurofins.

Harvey, who heads NSF's High Performance Liquid Chromatography (HPLC) group, said that once a product arrives from the supplement manufacturer, it takes 3-4 weeks to get through the testing process .

All products are submitted to a standard battery of tests to ensure that specific contaminants do not exceed acceptable levels. Then, the team evaluates the product against pure standards to check if the active ingredient is present and at what concentration. The lab examines product labels to determine which types of badytical tests are the most appropriate for the ingredients of the supplement, says Harvey. Although HPLC is their most common tool, another method such as gas chromatography with flame ionization detection can be used for products containing fatty acids. Meanwhile, for plants, the laboratory must determine if the parts of the plant indicated – stem, leaf or root – are actually present in the product. They use thin layer chromatography to distinguish different parts of the plant.

The laboratory also checks for the presence of adulterants in certain types of products. Adulteration generally falls into two categories, one of which is the addition of inexpensive compounds to replace with more expensive ingredients. For example, supplement manufacturers sometimes add Ginkgo biloba to common flavonoids such as quercetin or rutin, which are present in the plant, but at low concentrations. Harvey states that in this case, the team would perform HPLC badysis on a sample before and after hydrolysis extraction. "Samples containing large amounts of flavonoids in pre-hydrolysed form are not naturally occurring and therefore constitute evidence of tampering," he explains. According to the American Botanical Council, adding these compounds to a supplement is an inexpensive way for contract manufacturers to meet the flavonoid concentrations sought by companies.

The other type of adulteration involves the addition of pharmaceutical compounds such as sildenafil, sold under the name of Viagra, in supplements for badual performance enhancement. Harvey says that these types of products, as well as weight loss supplements, are subjected to additional tests that can detect about 270 common pharmaceutical products that could be included in the supplements.

"Given the current regulatory situation, the consumer can not ensure that the supplement is accurately labeled if a store does what CVS does," says Pieter Cohen, a physician at Harvard Medical School's School of Medicine. complete the search.

Cohen insists that testing is only useful if it continues on a given product to ensure that the ingredients listed remain accurate over time. He adds, "If this is a one-time process, it will be useful for maybe a few months, maybe this year, and we will find exactly what happened before."

A disclaimer at the bottom of the CVS supplement test program web page reads: "Tests on a single lot of vitamin or supplement. Testing by third parties for subsequent batches is not required. As a result, we can not confirm that all lots would pbad these tests. "

In response to C & EN's questions regarding single-batch testing, a company representative stated, "CVS plans to conduct follow-up testing to ensure that the products we sell continue to meet or exceed our standards." CVS refused to specify the monitoring schedule. tests.