After results from third-party testing confirmed its herbal supplement products are safe, pure, properly labeled and in full compliance with regulatory requirements, GNC Holdings, Pittsburgh, PA, reached an agreement with New York Attorney General (NY AG) Eric Schneiderman’s office whereby the retailer will begin utilizing DNA barcode testing within 18 months to confirm the authenticity of all plants used as sources for its herbal dietary supplements prior to processing.
 
According to the NY AG’s office, “This will ensure the presence of a biological connection between the source plant and the extract that is eventually included in GNC’s supplements. In cases where no DNA barcode is yet available for the relevant species, GNC has committed to perform its own sample collection—DNA isolation and sequencing—to create a DNA barcode for that plant ingredient. GNC will contribute any new barcodes, and the scientific methods used to identify them, to a publicly accessible database within 24 months.”
 
To assure authentication, GNC will also require that all herbal ingredients used in its products are manufactured in facilities that are certified as good manufacturing compliant by a third-party accreditation body, such as ISO, USP or NSF.
 
Other points of the agreement include, according to the NY AG:
 
Broad Testing For Contaminants: GNC will implement a sweeping, randomized testing protocol for the eight most common allergens—defined by FDA as milk, eggs, peanuts, tree nuts, fish, shellfish, soy and wheat. This will include testing certain raw ingredients for contamination and, after production, ensuring that those allergens are not present in its products. In order to do this, GNC will not only require its suppliers to implement this testing protocol, but will also perform testing themselves on finished products, using a scientifically-validated technique. In addition, GNC will also conduct testing to confirm any affirmative representations on its labels that particular ingredients are absent from certain products (e.g., “No sugar.”)
 
Consumer Transparency: GNC will prominently display signs in stores across the country and include language on its website indicating whether a supplement product is derived from whole herbs or extracts and explaining the difference between those two processes. In particular, these signs will highlight that extracts are chemicals derived from plants after applying solvents, like liquid carbon dioxide. GNC will list all ingredients used in its products on its labels, per existing FDA rules.
 
Reporting: GNC will provide semiannual reports to the Attorney General’s Office, detailing all plant species sourced after authentication using DNA barcoding; the name and address of all facilities in which DNA barcode authentication was performed; a list of materials rejected as a consequence of the results of the barcoding and the results of the randomized testing for common allergens. GNC will provide additional documentation and information necessary for the Attorney General’s Office to verify compliance with this agreement without the necessity for a subpoena. 
 
In response to the Attorney General’s cease-and-desist letter, GNC removed from its shelves all products that the office’s testing found to contain contaminants not identified on their labels. As described in the agreement, those products remain off of store shelves, according to the NY AG.
 
ABC & AHPA React
American Botanical Council (ABC) Founder and Executive Director Mark Blumenthal, who was quoted in a New York Times article published on March 30, noted the appearance of a false presumption that GNC had agreed to what are most likely the AG’s stipulated terms because the retailer had been seen as selling substandard herbal dietary supplements. However, in the agreement there is reportedly no admission of wrongdoing on behalf of GNC, and analytical experts have raised serious doubts about conclusions that have been drawn from the faulty application of DNA barcode technology to GNC’s products, which were all botanical extracts.
 
American Herbal Products Association (AHPA) President Michael McGuffin said GNC’s agreement provides “clear evidence that current federal regulation of dietary supplement manufacturing is effective,” noting the NY AG’s testing didn’t reach a final determination that tested supplements were fraudulent, and the AG found no evidence that GNC deviated from FDA’s cGMPs.
 
“In response to the AG's initial accusations, GNC had the complained-about products tested by an independent third-party using scientifically valid methods to demonstrate the products contain what they claim to contain," Mr. McGuffin said.
 
AHPA shares the NY AG’s goal of ensuring consumer access to high-quality herbal products, he added. “However, DNA testing will add no additional assurance of the correct identification of any herbal ingredient that has already been verified by one or more of the other long-established analytical tools now used by responsible herbal manufacturers. Regulations, requirements and best practices for botanical identification and supplement manufacturing should be based on valid science coupled with qualified expertise and experience. AHPA will continue to support the use of these well-established methods and evaluate new methods as they are developed and determined to be valid."
 
CRN: ‘Disservice to Consumers’
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), called the agreement a disservice to consumers, “because it wrongly perpetuates the misdirected notion that DNA barcode testing is appropriate for herbal supplements, when it is not.”
 
“Moreover, the agreement gives credence to the New York AG’s misguided allegations based on its own DNA barcode testing that legitimate quality concerns existed about the products marketed by four retailers, when there were none,” Mr. Mister continued. “DNA barcode testing remains a flawed method for across-the-board testing for analyzing the quality of botanical ingredients and finished products.”
 
The announcement “substitutes reasoned judgment of scientists and federal experts with a politically-motivated mandate that does not advance the conversation around the quality of dietary supplements,” he added.
 
Mr. Mister went on to acknowledge the difficult position the NY AG’s investigation has put retailers in; as they face consumer confidence concerns, retailers have pulled products in question from store shelves, and several class-action lawsuits have been filed in the wake of the testing controversy.
 
However, ultimately, “federal law already requires dietary supplement manufacturers to adhere to good manufacturing practices (GMPs), including meeting product specifications for identity, purity, strength and composition, and to perform ‘at least one appropriate test’ for the identification of raw materials. FDA, the federal agency charged with enforcing these requirements, does not require DNA barcode testing for plant identification of dietary supplements, nor does it use DNA sequencing by itself for identification of herbal extracts.”
 
Mr. Mister further noted the NY AG has refused to release details about its testing despite calls for transparency and significant doubts about the validity of applying DNA barcode testing for botanical extracts. “The announcement further entrenches a state attorney general’s office in a regulatory matter in which it has no expertise and substitutes face-saving requirements for meaningful advancement of the industry.”
 
NPA: ‘Giant Charade’ & ‘A Dangerous Precedent’  
Natural Products Association (NPA) CEO and Executive Director Daniel Fabricant, PhD, welcomed the return of safe products back to store shelves. “We still want to see the attorney general’s research, however, because the more we learn, the more this action looks like a giant charade. At this point, the only result of this unfounded witch-hunt was to pull safe products off the shelves and inconvenience thousands of customers in New York. Meanwhile, the Food and Drug Administration has been incredibly silent during the whole affair, which should tell us a lot about the merits of this incursion.”
 
The dietary supplement cGMPs are adequate to demonstrate identity, purity, strength, composition, and limits on contaminants for ingredients in dietary supplement products, Dr. Fabricant stated, and GNC has provided evidence that appeared to satisfy the New York attorney general.
 
“It’s important to note here,” he added, “that dietary supplements containing botanical ingredients must list the part of the plant used in the final product. DNA barcoding will not provide useful information as to whether roots, stems, leaves or flowers are used in the supply of the raw material; however, chemical fingerprinting can distinguish the difference and provides a useful comprehensive tool for dietary supplement manufacturers to meet label claim for their listed botanical ingredient.”
 
NPA does not support the use of DNA barcoding alone to verify and authenticate botanical ingredients, Dr. Fabricant said. “DNA barcoding may be used in conjunction with a chemical chromatographic method, which compares the actual phytochemical profile against that of a known voucher specimen.”
 
While NPA recognizes the value of DNA barcoding for raw botanical materials in the supply chain, it should not be used on botanical extracts and highly processed finished products for botanical authentication. “DNA barcoding is one tool, and if a firm meets 100 percent identity testing using a chemical fingerprinting method (i.e., chromatographic), then the firm is in full compliance with the federal statute. The FDA also does not mandate the use of DNA-based technologies to authenticate botanicals.”
 
Aside from the testing method controversy, FDA has full regulatory authority over the dietary supplement industry, Dr. Fabricant noted, and when it finds an issue with a product, it takes action to protect the public health and remove the product from commerce.
 
“The actions by the New York attorney general set a dangerous precedent of state officials stepping on the toes of the federal government, and removing products from store shelves without having the adequate regulatory authority and proper scientific understanding to do so. What’s more, NPA is concerned that these actions could lead to each state instituting its own identity testing standards, preempting federal authorities already in place. It may also set a precedent for class action lawsuits over a state requirement, which has neither federal support nor scientific merit when applied to botanical extracts and finished dietary supplement products.”
 
Although it has been established that the methodology used by the attorney general was not fit for purpose, NPA said it will continue to request that Mr. Schneiderman release the full details of his report. “Additionally, NPA welcomes the opportunity to sit down with the attorney general and his researchers to discuss the findings and appropriate next steps for all parties.”