In an agreement reached with the New York Attorney General, a nutraceutical manufacturer says it will use DNA barcoding to confirm the authenticity of herbal or botanical ingredients prior to extraction that are used in its six herbal supplements.
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GNC, the nutraceutical company, was one of four retailers, including Walgreen, Walmart, and Target, that removed their supplements from retailers’ shelves in New York earlier this year in response to subpoenas requiring that they provide support for health claims printed on the labels. DNA barcoding showed that only 21 percent of the tested supplements contained plants listed on the labels and that many products did not contain any DNA from a botanical source.
The agreement states that the attorney general found no evidence that GNC had deviated from the FDA’s Good Manufacturing Practices or standard industry practices in its production of herbal supplements. According to the agreement, the attorney general is “concerned that standard chemical approaches provide inadequate assurance of the authenticity of herbal supplements” and that FDA regulations “allow for low levels of inadvertent contamination.” As part of the agreement, GNC will contribute any DNA barcodes and the scientific methods used to identify the barcodes to a publicly accessible database for all of the active herbal or botanical ingredients used in its supplements.
Daniel Fabricant, CEO and executive director of the Natural Products Association (NPA), issued a statement after the agreement was announced, saying that his organization “does not support the use of DNA barcoding alone to verify and authenticate botanical ingredients,” and noted that the FDA does not mandate the use of DNA-based technologies to authenticate botanicals.
U.S. Pharmacopeia has also said that DNA barcoding is not the best test for supplements that contain extracts because the DNA can be destroyed or degraded by solvents and heat used in the extraction process.
Ben Pascal, chief business officer at Invisible Sentinel, a Philadelphia-based company that develops and manufactures microbial detection tools, says his company has seen a “significant uptick in testing” by nutraceutical manufacturers. “These companies are becoming more proactive, recognizing that their products contain very exotic ingredients from countries that may not have the same food safety standards as the U.S.”
Nutraceuticals are often more difficult products to test than food, Pascal says. “You are talking about 50, 60, 100 ingredients in one product.” Manufacturers working with Invisible Sentinel want to test not only their finished products but also want to test the raw ingredients, he says. “Many want molecular methods that can handle these challenging matrices, and they are starting to expand their testing scope to cover multiple pathogens not traditionally associated with these products. It’s a nice trend to see.”