New York Attorney General Signs Agreement with GNC Requiring Use of DNA Barcoding as a Quality Control Method for Botanical Dietary Supplements

As noted in the previous issue of the “Botanical Adulterants Monitor,” on February 3, 2015, New York Attorney General Eric T. Schneiderman announced that his office had sent letters to four major retailers – GNC, Walgreens, Walmart, and Target – with cease-and-desist orders regarding the sale of store-brand herbal supplement products in the state of New York. The AG-sponsored DNA barcoding technique applied was unable to verify that the products contained the labeled substance, or found ingredients not listed on the labels. On March 27, 2015, the NY AG’s office and GNC signed an agreement allowing GNC to resume retail sales in the state of New York of the same house-brand botanical dietary supplements. In the agreement, the NY AG explicitly stated that “NY AG found no evidence in the course of its investigation that GNC deviated from the federal Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs) rules or standard industry practice in the production of the tested supplements.”

The agreement contains a number of requirements that will likely affect ingredient suppliers, manufacturers of dietary supplements, and contract analytical laboratories who are currently supplying, or in the future will be supplying, botanical ingredients to GNC. (GNC has 18 months to comply with the terms of the agreement.) The requirements include, among others, the following:

-        the implementation of DNA-based authentication of crude raw materials prior to extraction for all herbal ingredients used in the GNC Herbal Plus^® brands

-        the contribution of any DNA barcodes, and the scientific methods GNC used to identify such DNA barcodes, to a publicly accessible database

-        GNC will require that all "active" herbal/botanical ingredients used in the GNC Herbal Plus brand product line manufactured and sold in the US be manufactured in cGMP-compliant facilities that are certified through a third-party accreditation body, such as International Organization for Standardization (ISO), US Pharmacopeia (USP), or NSF International.

-        GNC will require that its suppliers implement a randomized allergen testing protocol. The allergen testing will employ the Polymerase Chain Reaction (PCR) or Enzyme-Linked Immunosorbent Assay (ELISA) to detect the eight most common allergens, as defined by FDA.

-        GNC will test finished products from the GNC Herbal Plus brand product line on an annual basis, using a scientifically validated technique, for the eight most common allergens.

Comment: There are two important issues regarding this agreement between GNC and the NY AG. The first is that the NY AG allowed resumption of retail sales of the products previously described as “mislabeled, contaminated” and “posing an unacceptable risk to New York families.” The return of these products to the shelves suggests that there is nothing objectionable or illegal about the products and (without admitting so publicly) suggests that the NY AG has come to the conclusion that the DNA barcoding tests were severely flawed and provided erroneous results. The second issue, with potential broad-reaching consequences for the industry, is GNC’s agreement to employ DNA barcoding as part of their ingredient identification testing. This may be seen by legislators, regulators, plaintiffs’ attorneys, and others as the gold standard for botanical ingredient testing. While DNA barcoding holds a lot of promise, and has been shown to be a very useful tool in the authentication of crude raw materials, it takes a lot of time and effort to develop a scientifically valid DNA authentication method that has effectively been shown to distinguish the raw material in question from its close relatives and from the plant’s known adulterants. General barcoding methods, such as the approach used by Newmaster et al. in the evaluation of herbal products published in 2013,¹ cannot be regarded as scientifically valid according to cGMPs. This is particularly relevant in cases where extracts are to be analyzed, and/or when two or more parts of the same plant have to be distinguished.

In the agreement with GNC, the NY AG makes the following comment to push for DNA-based authentication of crude herbal materials: “[T]he FDA allows companies to support their claims through other [than DNA] methodologies, including chemical analysis methods, like those employed by GNC. Given the existence of chemically-similar natural or synthetic substitutes, NYAG is concerned that standard chemical approaches provide inadequate assurance of the authenticity of herbal supplements.”² It is unclear, however, how DNA technology would allow the assurance of the authenticity of an herbal supplement in the presence of “chemically-similar natural or synthetic substitutes.” Ironically, the presence of synthetic substitutes can only be detected by chemical means. The suggestion that DNA barcoding as applied today supersedes other analytical techniques, including botanical, macro/morphological, and chemical assessment, is problematic and – if accepted as such – would establish an ill-suited precedent for identity and quality assessment of botanicals.

Reference

1.     Newmaster SG, Grguric M, Shanmughanandhan D, Ramalingam S, Ragupathy S. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013;11:222. doi: 10.1186/1741-7015-11-222. Available at: http://www.biomedcentral.com/1741-7015/11/222. Accessed May 27, 2015.

2.     Schneiderman ET letter to Archbold MG. Re: GNC-Brand Herbal Supplements. March 27, 2015. Available at: http://www.ahpa.org/Portals/0/pdfs/New_York_Attorney_General_GNC_Herbal_Supplement_Agreement.pdf. Accessed May 27, 2015.