04.09.15
GNC’s chief executive officer Mike Archbold issued a letter clarifying they company’s response to NY Attorney Eric Schneiderman’s investigation into its Herbal Plus line. Many have questioned what GNC’s agreement with the NYAG means for the larger industry, and why it committed to more extensive testing after it was determined its products were safe and compliant with regulatory requirements.
Mr. Archbold pointed to four key factors that led the company to its agreement with the NYAG:
“Establishing Ultimate Clarity. The following language was the lynchpin in reaching an agreement and demonstrates, beyond any doubt, the purity, safety and quality of our products:
'NYAG 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…'
Going Above and Beyond. Consumers can take great confidence in purchasing supplements — like those produced by GNC —which are manufactured in strict adherence to the federal cGMPs. That said, we have always gone above and beyond to assure compliance with FDA cGMPs in pursuing product quality for consumers. Over the years, GNC, along with the rest of the industry, has continued to evolve our testing. The new processes we are implementing are a natural part of this evolution consistent with FDA cGMPs which form the minimum requirements for our industry. Going beyond those requirements, as we agreed to do in this settlement, is in the best interests of our customers and will increase confidence in our industry.
New Standards in Testing. Even noted critics of our industry agree that the use of DNA barcode testing on finished extract products — as performed by the NYAG — is not appropriate. However, DNA barcode testing may someday play a role in the identity testing of some source materials earlier in the production process. This will not in any way affect product quality for GNC’s products, but will provide even greater assurance of plant identity prior to extraction, which may help avoid the rejection of extracts later in the testing process. GNC has agreed to devote resources to advance this new technology in a scientifically valid way.
To be clear, we have agreed to implement source material standards that utilize DNA barcode testing to confirm the authenticity of the “active” herbal/botanical ingredients prior to extraction, complementing existing validated testing performed at subsequent stages of the supply chain. And random testing for allergens not only assures the integrity of the supply chain but also acts as additional validation of existing quality systems.
DNA barcode testing is one appropriate test for identity, but it will not replace current testing. It will be duplicative of, and in addition to, the robust testing we already conduct on our herbal supplement products.
The Role of the NYAG. As stated in our agreement, GNC and the NYAG “disagree on the sufficiency of federal rules and testing requirements and their relationship to state consumer protection laws.” Nonetheless, GNC has chosen to work with the NYAG to continue to assure the highest quality products for consumers.“
Mr. Archbold concluded the letter suggesting that the industry should not fear more rigorous testing methods, but rather embraced them to ensure consumer trust.
Mr. Archbold pointed to four key factors that led the company to its agreement with the NYAG:
“Establishing Ultimate Clarity. The following language was the lynchpin in reaching an agreement and demonstrates, beyond any doubt, the purity, safety and quality of our products:
'NYAG 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…'
Going Above and Beyond. Consumers can take great confidence in purchasing supplements — like those produced by GNC —which are manufactured in strict adherence to the federal cGMPs. That said, we have always gone above and beyond to assure compliance with FDA cGMPs in pursuing product quality for consumers. Over the years, GNC, along with the rest of the industry, has continued to evolve our testing. The new processes we are implementing are a natural part of this evolution consistent with FDA cGMPs which form the minimum requirements for our industry. Going beyond those requirements, as we agreed to do in this settlement, is in the best interests of our customers and will increase confidence in our industry.
New Standards in Testing. Even noted critics of our industry agree that the use of DNA barcode testing on finished extract products — as performed by the NYAG — is not appropriate. However, DNA barcode testing may someday play a role in the identity testing of some source materials earlier in the production process. This will not in any way affect product quality for GNC’s products, but will provide even greater assurance of plant identity prior to extraction, which may help avoid the rejection of extracts later in the testing process. GNC has agreed to devote resources to advance this new technology in a scientifically valid way.
To be clear, we have agreed to implement source material standards that utilize DNA barcode testing to confirm the authenticity of the “active” herbal/botanical ingredients prior to extraction, complementing existing validated testing performed at subsequent stages of the supply chain. And random testing for allergens not only assures the integrity of the supply chain but also acts as additional validation of existing quality systems.
DNA barcode testing is one appropriate test for identity, but it will not replace current testing. It will be duplicative of, and in addition to, the robust testing we already conduct on our herbal supplement products.
The Role of the NYAG. As stated in our agreement, GNC and the NYAG “disagree on the sufficiency of federal rules and testing requirements and their relationship to state consumer protection laws.” Nonetheless, GNC has chosen to work with the NYAG to continue to assure the highest quality products for consumers.“
Mr. Archbold concluded the letter suggesting that the industry should not fear more rigorous testing methods, but rather embraced them to ensure consumer trust.