New York State Attorney General Eric T. Schneiderman has announced a landmark agreement with vitamin and supplement retailer GNC to implement new standards in authenticating herbal supplements, ensuring their purity, and educating consumers about their chemical content.
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 agreement came after Schneiderman sent cease-and-desist letters to GNC, Target, Walgreens and Walmart after a study commissioned by his office 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.
“When consumers take an herbal supplement, they should be able to do so with full knowledge of what is in that product and confidence that every precaution was taken to ensure its authenticity and purity,” said Schneiderman. “When it comes to consumer health, we expect companies to reach a high safety bar. Without tests and safeguards, including those that rule out dangerous allergens, these supplements pose unacceptable risks to New York families. I urge all herbal supplements manufacturers and retailers to join GNC in working with my office to increase transparency and put the safety of their customers first.”
Josh Bloom, 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.”
While the Attorney General’s Office found that GNC’s herbal supplements were produced in compliance with FDA regulations requiring the use of current good manufacturing practices, the investigation raised questions regarding the sufficiency of those requirements in relation to state consumer protection laws. For instance, the FDA does not mandate the use of DNA-based technologies, like barcoding, to authenticate herbal supplements. Instead, the FDA allows companies to support their claims through other methodologies. Given the existence of chemically-similar natural or synthetic substitutes, the Attorney General’s Office remains concerned that these alternate methodologies do not provide adequate assurances of the authenticity of herbal supplements. Current FDA regulations allow for low levels of inadvertent contamination, including from allergens, and there is no federal testing required to confirm that contamination falls below relevant safety thresholds.
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.
DNA barcoding is a technique used to authenticate organic materials using unique reference sequences of DNA, which holds great promise as a scientific technique for the verification of plant species. GNC will commit to implementing this procedure during herbal supplement production, enhancing other aspects of its operations, and leading the industry to adopt the same standards, as follows:
Authentication: Within 18 months, GNC will begin utilizing DNA barcoding 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.