GNC Holdings has reached a deal with New York State Attorney General Eric Schneiderman to implement new testing standards for its herbal supplements that will make it the first in the country to go beyond current federal requirements.
The agreement (PDF) announced Monday will require the retailer to perform testing on all “active” plant ingredients listed on labels of its supplement products, as well as test for contamination with allergens before and after production. GNC will be required to implement the procedures for all its products at its more than 6,000 stores nationwide.
“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,” Schneiderman said in a statement released Monday. “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.”
The agreement comes in the wake of cease-and-desist notices Schneiderman's office sent to GNC, as well as fellow retail chains Target Corp., the Walgreen's holding company Walgreens Boots Alliance, and Wal-Mart Stores, in February for the sale of their store-brand supplements.
The action was taken following an investigation that found that genetic material for the plants depicted on the labels for most of the products sold at those stores were not detected in the actual products. The study further detected DNA associated with plants not listed on the labels, as well as the presence of potential allergens.
The attorney general found GNC supplements were produced in compliance with current regulations from the U.S. Food and Drug Administration, which raises questions as to whether federal standards were sufficient to ensure quality and safety of such products.
FDA rules governing herbal supplements are not held to the same standards as prescription drugs and do not undergo the same type of rigorous testing requirements before being sold.
Current FDA regulations do not mandate use of DNA-based technologies to authenticate supplement ingredients. Under the agreement, GNC will begin verifying the organic materials within its supplement using a technique called DNA bar coding over the next 18 months. The company will also conduct randomized testing for detection of the eight most common allergens—milk, eggs, peanuts, tree nuts, fish, shellfish, soy and wheat.
GNC will provide semiannual reports on safety to the New York attorney general's office, and indicate in language used on store signs whether a supplement is derived from whole herbs or extracts, and explain the difference between those processes.
In particular, such signs will highlight that extracts are chemicals derived from plants after applying solvents, such as liquid carbon dioxide. GNC will list all ingredients used in its products on its labels, per existing FDA rules.
In response to the announcement, GNC released a statement saying the agreement reached affirmed their products were “not only safe and pure, but are in full compliance with all regulatory requirements,” CEO Michael Archbold said.
“A robust testing regime, careful sourcing regimen and detailed manufacturing specifications have always been core elements to ensuring that we provide our customers with high-quality products,” Archbold said. “Our customers trust and value our products, and we are steadfastly committed to maintaining that trust and confidence—as an industry leader we have always gone above and beyond the minimum requirements in pursuing quality for our consumers, and we will continue to lead the efforts for higher standards.”
It was not clear whether Target, Walgreen Co. and Wal-Mart would begin conducting similar testing of their supplements.
The Council for Responsible Nutrition, a leading trade group for the dietary supplements manufacturing industry, blasted the deal.
“The agreement announced today between the New York Attorney General and GNC performs a real disservice to consumers because it wrongly perpetuates the misdirected notion that DNA barcode testing is appropriate for herbal supplements, when it is not.,” said Steve Mister, CEO of CRN in a released statement. “Today's 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. “