Just a month after getting a cease and desist letter from New York State Attorney General Eric T. Schneiderman, GNC has become the first vitamin and supplement retailer to implement new standards in authenticating herbal supplements, ensuring their purity, and educating consumers about their chemical content. 

That isn't a perfect solution, the perfect solution would be to have labels such as 'this is unsubstantiated nonsense' but capitalism applies to all legal products, especially if they are legitimized by $120 million in federal spending by the NIH National Center for Complementary and Alternative Medicine.

Under the agreement, GNC will perform DNA barcoding on the “active” plant ingredients used in its products, implement testing for contamination with allergens, both before and after production, and post prominent signage advising consumers of the processed, chemical nature of extracts. GNC will be required to implement these new procedures in all of its more than 6,000 stores nationwide, making this agreement the first in the nation to require testing standards for herbal supplements that exceed current FDA requirements.

The cease-and-desist letters went out to GNC, Target, Walgreens and Walmart after a government study commissioned failed to detect identifiable genetic material for the plants depicted on the labels in most of the four retailers’ herbal supplement products. The study further detected DNA associated with plants not listed on the labels, as well as the presence of potential allergens. In launching his investigation, the Attorney General raised concerns about the measures put in place by manufacturers and retailers to ensure the authenticity and purity of herbal supplements – which are taken by more than half of all American adults – and the sufficiency of federal standards regulating this $60 billion worldwide industry. 

Josh Bloom, Ph.D., Director of Chemical and Pharmaceutical Science, American Council on Science and Health said, “Although this agreement is certainly an improvement from the standards that have been in place, and Attorney General Schneiderman should be applauded for his work in this area, this is only the first step. Congress has stripped the FDA of the ability to approve or reject these products, which are essentially unregulated drugs."

David S. Seres, M.D., Director of Medical Nutrition at Columbia University Medical Center said, “When federal law prohibits the kind of regulation that we demand on all other products used for health benefits, the Attorney General’s actions represent an important step in reining in the supplement industry and assuring that the consumer can trust what is in the bottle.”

Contamination in herbal supplements could pose a significant danger to those who have food allergies or take medication – and there have been a number of examples of supplements endangering consumer safety. A 2013 outbreak of hepatitis that struck at least 72 people in 16 states was traced to a tainted supplement. Last October, an infant at a Connecticut hospital died when doctors gave the child a popular probiotic supplement that was later found to be contaminated with yeast.

Within 18 months, GNC will begin utilizing DNA barcoding, a technique used to authenticate organic materials using unique reference sequences of DNA to confirm the authenticity of all plants used as sources for its herbal supplements products prior to processing. 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.
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.

Broad Testing For Contaminants: GNC will implement a sweeping, randomized testing protocol for the eight most common allergens – defined by the 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.

The broader investigation into the herbal supplements industry is being handled by Assistant Attorney General Dorothea Caldwell-Brown, Research Analyst John Ferrara, Research Director Lacey Keller, Chief of the Environmental Protection Bureau Lemuel Srolovic and Executive Deputy Attorney General for Economic Justice Karla Sanchez.