The agreement, which can be read HERE, also includes a commitment from NBTY to test for allergens, to submit to third party certification, and to double on-site audits of its major suppliers.
“When consumers take an herbal supplement, they should be able to do so confident that the plant on the label is the plant in the bottle, and that every reasonable precaution was taken to ensure the product’s authenticity and purity,” said AG Schneiderman in a press release.
“Consumers can only have that confidence if the companies that sell herbal supplements employ the best and most reliable testing measures for combating fraud and ruling out dangerous allergens. I am pleased that NBTY has joined GNC and Nature’s way and agreed to increase transparency, improve quality control, and do more to protect consumers, and I urge the rest of the herbal supplements industry to do the same.”
NBTY: “Pleased to have reached an agreement”
“We are pleased that through cooperation and mutual understanding we have reached an agreement with the New York Attorney General,” NBTY General Counsel Stratis Philippis said in a statement.
“NYAG found no evidence that our Company deviated or failed to comply with FDA requirements or industry standards.
“While it is NBTY’s position that DNA testing of herbal dietary supplements is an emerging science in developmental stages, NBTY and the NYAG have a shared commitment to promote the development of the most accurate, reliable standards and testing methods for the authenticity of herbal dietary supplements. We hope this will help create reliable DNA testing that could be an additional tool for authenticity testing of herbal raw materials for our entire industry going forward,” added Philippis.
Under the terms of the agreement, NBTY will phase in DNA barcoding on herbal ingredients within two years. By the end of year one, NBTY will test all ingredients derived from no fewer than 12 distinct species. By the end of the second year, the company will extend testing to all herbal ingredients with a reliable and scientifically valid barcode.
In addition, NBTY will take concrete steps to partner with Cornell University and other major research institutions to further the transparency and traceability of herbal dietary supplements, including through DNA barcoding.
The agreement build on previous ones with GNC and Nature’s Way, said the AG’s office. The March 2015 agreement with GNC that required the Pittsburgh-based company to perform DNA barcoding on the “active” plant ingredients used in its products, and to implement a series of other measures to enhance the authenticity and purity of their products. In September, 2015, AG Schneiderman reached an accord with Nature’s Way, which agreed to improve the manufacturing and marketing of an herbal supplement derived from devil’s claw (Harpagophytum procumbens), and announced that it would employ DNA barcode testing across its major herbal products lines.
“The federal Food and Drug Administration (“FDA”) does not mandate the use of DNA-based technologies, like DNA barcoding, to authenticate herbal supplements. Instead, the agency permits companies to support their claims through the use of one or more scientifically valid methodologies, including chemical profiling methods of the types employed by NBTY,” states the agreement.
“NBTY cooperated with NYAG’s investigation, providing documentation of its manufacturing practice and testing regimes. NYAG found no evidence in the course of its investigation that NBTY deviated from, or failed to administer, the testing procedures mandated by the FDA’s “Current Good Manufacturing Practices” (“cGMPs”) rules or standard industry practice in the production of the NBTY manufactured herbal dietary supplements at issue in this investigation (“Tested Supplements”).”
DNA barcoding: “An emerging science”
The agreement notes that NBTY’s position in that DNA testing of herbal supplements is an emerging science and that there are no “scientifically verified standards and methodologies utilizing DNA testing that could be considered accurate and reliable […] for establishing the authenticity of finished herbal dietary supplements”.
On the flip side, the NY AG has maintained its position that DNA barcoding provides a “powerful and scientifically valid method for identifying potential fraud and contamination in the herbal supplement supply chain”.
As reported by NutraIngredients-USA in 2013, DNA barcoding offers a lot of potential for botanical testing, and is incredibly reliable, but only when performed on appropriate material. Industry experts claimed, however, that botanical extracts are problematic because, while some extracts may contain DNA, it is often of low quality or degraded to a point that makes it impossible to perform proper authentication.
In addition to questions about the technology’s appropriateness for botanical extracts, the two most cited limitations of DNA technology are that, i) it cannot differentiate between plant parts (leaf, stem, root – the DNA is the same), and ii) it’s not totally quantitative (ie. it doesn’t tell you how much is in there).
Scientists from the US Food and Drug Administration and an Australian research consortium both presented data at the prestigious 16th Annual Oxford International Conference on the Science of Botanicals at the University of Mississippi in April, 2016 that led to the conclusion that DNA barcoding by itself is not an adequate method for analyzing botanical dietary supplements.
This stance was supported by a review, authored by experts from the National Center for Natural Products Research at the University of Mississippi, the American Botanical Council, and the University of British Columbia, which stated: “[T]he manufacturing process of herbal products that involves extensive heat treatment, irradiation, distillation, filtration, UV light exposure, and/or supercritical fluid extraction leads to either complete removal of DNA or degradation of DNA into smaller fragments. Hence, DNA barcoding is not feasible for processed herbal products such as extracts and tinctures in which the DNA is not present at all or highly degraded.”
The full paper is available as an open access article in Planta Medica.
Despite this, the NY AG’s office has continued to maintain its position that DNA barcoding is a “critical” tool. A spokesperson for AG’s office emailed us the following statement in April: “We believe that DNA barcoding is a critical part of improving the industry’s approach to ensuring identity and avoiding contamination.
“We’re heartened by the responsible voices in the supplements industry who agree—and are beginning to incorporate DNA barcoding as part of their testing protocols.”