While standing firmly behind the quality, purity and potency of all ingredients listed on the labels of GNC private label products, including the GNC Herbal Plus® line of products, GNC Holdings Inc. (NYSE: GNC) announced that it will voluntarily comply with the New York State Attorney General's letter of Feb. 2 by temporarily removing from our stores in New York the product lots cited in the letter.
In making the announcement, the Company said it will provide the Attorney General's staff with a reasonable opportunity to review GNC's full and robust response to its questions on, among other things, the standards and procedures GNC follows in authenticating the content of the GNC Herbal Plus products cited in the letter, including finished products testing results based on validated testing protocols. GNC is confident that its response will demonstrate that the five products in question are fully compliant, safe and properly labeled. GNC is hopeful that the Attorney General's staff will promptly reach the same conclusion.
GNC expects to again make these products available to our customers in New York State after providing the State a reasonable time for review.
The Company also made these additional points:
- GNC tests all of its products using validated and widely used testing methods, including those approved by governing bodies like the United States Pharmacopeia and the British Pharmacopeia.
- GNC Herbal Plus products meet all federal regulatory standards as monitored by the Food and Drug Administration, our primary federal regulator. And there are no adverse event reports concerning these products.
- The DNA barcoding technology employed on behalf of the Attorney General's office in testing GNC Herbal Plus products has not been approved by the United States Pharmacopeia and may not be appropriate for the testing of these herbal products. The Attorney General's office has refused to provide the test data to GNC.
- In a discussion of DNA barcoding technology contained in its story of Feb. 3, the New York Times stated that Dr. Pieter Cohen, a consistent supplement industry critic andHarvard Medical School assistant professor, told the Times reporter that "the Attorney General's test results were so extreme that he found them hard to accept. He said it was possible that the tests had failed to detect some plants even when they were present because the manufacturing process had destroyed their DNA."
The Company also noted that all of the major supplement industry groups fully support its position on the doubtful validity of the testing methodology used by the Attorney General's office to come up with its findings:
- Natural Products Association: Natural Products Association Executive Director Daniel Fabricant, Ph.D., who headed the Food and Drug Administration's Division of Dietary Supplements until last spring, also notes that the testing processes that New York State Attorney General Schneiderman cites needs to be questioned. We don't know what was tested, or how it was tested, he says. Dr. Fabricant further notes that the products tested were extracts and the testing results were unsurprising, given the refining processes used. "You can't even start to draw any conclusions or learn anything from it," said Dr. Fabricant, who holds a Ph.D. in Pharmacognosy.
- Council for Responsible Nutrition: "These actions today by the New York StateAttorney General's (AG) office smack of a self-serving publicity stunt under the guise of protecting public health. Supposed concerns about the products in question are based on a novel testing method that has been roundly criticized by botanical scientists who question whether DNA barcoding technology is an appropriate or validated test for determining the presence of herbal ingredients in finished botanical products. Processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products."
- American Herbal Products Association: "The New York State Attorney General used an inadequate and unproven analytical method to test herbal supplement products at the core of the State's allegations that several retailers are selling adulterated and/or mislabeled herbal dietary supplements. The results of this analysis, therefore, cannot be considered valid...(the) Attorney General and the laboratory that conducted the analysis relied on an analytical technology that does not have the capacity to reach the degree of certainty represented by the State in its accusations."
- American Botanical Council: "The New York Times contacted the American Botanical Council (ABC) for comment regarding the AG's action. The following statement was submitted but not included in any of the Times' coverage of the issue thus far: The AG's study is not based on adequate science and its actions are thus premature. The use of DNA barcoding technology for testing of the identity of botanical dietary supplements is a useful but limited technology. DNA testing seldom is able to properly identify chemically complex herbal extracts as little or no DNA is extracted in many commercial extraction processes."