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Laura Bush is a former managing editor of Pharmaceutical Technology. She is currently the Editor-in-Chief of BioPharm International, a sister publication of Pharmaceutical Technology. 485 Route One South, Building F, First Floor, Iselin, NJ 08830, firstname.lastname@example.org, tel. 732.346.3020
In response to recent accusations levied by the New York State Attorney General’s office that herbal supplements sold by four major retailers contained little or no primary ingredient, the supplements industry is planning further testing of the affected products.
In response to recent accusations levied by the New York State Attorney General’s office that herbal supplements sold by four major retailers contained little or no primary ingredient, the supplements industry is planning further testing of the affected products. The industry’s action is prompted by the belief that the original testing was conducted using an inappropriate analytical method.
Shortly after the news broke on February 2, the United Natural Products Alliance (UNPA, Salt Lake City, Utah) put out a call to its members asking them to purchase samples of the products. The association has sent the sealed samples, including those from the product lots affected by the actions of state attorney general’s office, to five independent laboratories for testing to determine if the botanicals listed on the product labels are indeed in the product at what levels. An independent expert panel will then review the results. The identities of the laboratories and panel members will be made available when the review is complete, which may be as soon as early March.
Loren Israelsen, the president of UNPA, said his group is following careful steps to secure the chain of custody of the products. “We are photographing and documenting every step, as we receive boxes of products and organize them for shipment to the labs,” he said. “The laboratories will receive unopened products, with the tamper-evident packaging intact.”
The state attorney general’s office sent cease-and-desist letters on February 2 to GNC, Target, Walmart, and Walgreens after DNA testing found little to no DNA of the primary ingredient of a range of house-brand herbal supplements, such as gingko biloba, ginseng, echinacea, and St. John’s wort. Experts have said that DNA barcoding is an inappropriate method for testing botanicals products, particularly those in the form of extracts, because the DNA of botanical ingredients is often destroyed during processing and purification. Instead, they say, the testing should have been conducted using primarily high-performance liquid chromatography (HPLC) and high-performance thin layer chromatography (HPTLC) methods, according to the corresponding United States Pharmacopeia monographs.
Although he expects that the HPLC and HPTLC tests will show different results from the DNA testing, Israelsen says the results will be made public regardless of the outcome. “If the study finds problems that needs to be resolved, I am confident that the manufacturers and retailers will respond appropriately,” he said.
Israelsen said he also believes the situation can have an upside for the industry. “Our intent is to try to take this highly unfortunate event as an opportunity to educate and explain the differences between different analytical methods and what reference materials are, and to raise the general understanding of this subject,” he said.