05.01.15
After results from third-party testing confirmed its herbal supplement products are safe, pure, properly labeled and in full compliance with regulatory requirements, GNC Holdings, Pittsburgh, PA, reached an agreement with New York Attorney General (NY AG) Eric Schneiderman’s office in late March whereby the retailer will begin utilizing DNA barcode testing within 18 months to confirm the authenticity of all plants used as sources for its herbal dietary supplements prior to processing.
Internal and independent third-party tests demonstrated that the company’s products contain all herbal extracts listed on their respective labels. In addition, a former senior FDA Good Manufacturing Practice (GMP) expert performed a comprehensive review of GNC’s manufacturing processes for the products at issue and found them to be in compliance with all applicable requirements. Accordingly, GNC has restored its full assortment of Herbal Plus products to all GNC stores in New York State.
GNC said it will expand its testing processes deeper into its supply chain by leading ongoing industry efforts to integrate source material traceability standards including DNA barcoding where appropriate (prior to extraction processes) and enhance other aspects of its operations to provide consumers greater confidence in its products. The company said it believes these measures will result in the adoption of stricter minimum standards across the broader industry.
“As our testing demonstrated, and this agreement affirms beyond any doubt, our products are not only safe and pure but are in full compliance with all regulatory requirements,” said Michael G. Archbold, CEO of GNC. “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. 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. This is good for consumers, good for the industry, and good for GNC.”
GNC has preserved the specific product lots of the five products that were the subject of this inquiry for use in defending the company against lawsuits that have been filed subsequent to the NY AG’s Feb. 2 cease-and-desist letter, despite the fact that there is no prohibition against the sale of such products. The company said it believes these lawsuits are completely without merit and will defend itself aggressively. Identical products to those that have been preserved remain available for sale to consumers at GNC stores in New York State.
What’s in the Agreement?
According to the NY AG office, in addition to authentication of plant source materials, the agreement includes the following measures:
Broad Testing For Contaminants: GNC will implement a sweeping, randomized testing protocol for the eight most common allergens—defined by 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 products. To do this, GNC will not only require its suppliers to implement this testing protocol, but will also perform testing itself on finished products, using scientifically validated methods. In addition, GNC will 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 AG’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 AG’s office to verify compliance with this agreement without the necessity for a subpoena.
GNC’s Reasoning
Many have questioned what GNC’s agreement means for the broader industry, and why the company committed to more extensive testing after it was determined its products were safe and compliant with regulatory requirements.
GNC’s Mr. Archbold issued a letter to industry defending the company’s actions. In that correspondence, he said the following language was critical to reaching an agreement: “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.”
In addition, he said “going above and beyond” cGMPs would reassure confidence among supplement users.
While DNA barcoding of finished extract product was not an appropriate test, he said the method may play a role in identifying source materials earlier in the production process. This added step, he said, will not change GNC’s products, but rather provide greater assurance to customers.
He added that random allergen testing not only assures the integrity of the supply chain, but also acts as additional validation of existing quality systems. Lastly, Mr. Archbold stressed that GNC and the NY AG “disagree on the sufficiency of federal rules and testing requirements and their relationship to state consumer protection laws.” Nonetheless, he said the company has chosen to work with the NY AG to continue to assure the highest quality products for consumers.
Mr. Archbold concluded the letter suggesting the industry should not fear more rigorous testing methods, but rather embrace them to ensure consumer trust.
Reactions & Implications
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), acknowledged the difficult position the NY AG investigation has put retailers in, as they face consumer confidence concerns and class-action lawsuits. However, he cautioned the industry against settling and making promises to the AG based on a flawed study that hasn’t been released publicly—and probably never will be.
The 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,” he said.
DNA barcode testing is an emerging analytical method, according to Mark Blumenthal, founder and executive director of the American Botanical Council (ABC). However, it is only one tool in a toolbox. One notable limitation of DNA barcode testing, for example, is that it won’t identify the plant part (i.e., root, stem, leaf, etc.)
“One of my main concerns is that science is being misapplied,” he said, adding that it would be extremely unfortunate if the NY AG’s misinformation and misuse of technology ultimately caused consumers to abandon legitimate health products.
While adulteration is still an issue for botanicals, Mr. Blumenthal has been spearheading an international program whose mission relates to education, scientific research, and quality of botanical dietary ingredients and related plant-derived materials. The ABC-AHP-NCNPR Botanical Adulterants Program is a consortium of independent non-profit organizations: the American Botanical Council, the American Herbal Pharmacopoeia (AHP) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi.
AGs Appeal to Congress
Meanwhile, 14 state attorneys general sent a letter to Congress on April 2 urging leadership to investigate the supplement industry and to consider “a more robust oversight role” for FDA. The letter claimed the safety and efficacy of dietary supplements is a matter of “deep public concern across the country,” and stated: “The FDA has long been aware of problems in the dietary and herbal supplement supply chain, from dubious ingredient sourcing to a failure to carry out proper testing on finished products.”
The coalition’s letter requested that Congress act in concert with FDA to explore and address the following:
1. The adequacy and effectiveness of existing quality assurance measures for verifying the source, identity, purity, potency, and quality of ingredients and fillers;
2. The adequacy and effectiveness of existing regimes for verifying the identity, composition, purity, potency, and quality of the finished products sold by domestic manufacturers and retailers;
3. The degree to which product labels and marketing, including use of the terms “natural,” “herbal,” and “extract,” mislead consumers about the contents of herbal and dietary supplements and whether the FDA should develop standards and restrictions governing their use;
4. The extent to which Congress should mandate, or direct FDA to develop, enhanced, uniform, industry-wide quality assurance and verification regimes to guarantee the source, identity, purity, and potency of materials incorporated into herbal and dietary supplements; and,
5. The extent to which Congress should mandate, or direct, FDA to develop enhanced manufacturing and supply chain management requirements for the industry to guarantee the safety and efficacy of the finished herbal and dietary supplements.
CRN’s Mr. Mister said it was noteworthy that only 15 AGs had signed the letter, as it was certainly presented to all 53. CRN has been actively meeting with state AGs to discuss the matters at hand. “We are gratified that the concerns go away once we’re given the opportunity to fully explain the issue,” he said. Additionally, the letter was addressed to the Senate Commerce committee, as opposed to the Health, Education, Labor and Pensions committee.
Still, in light of fallout from all the negative attention, Mr. Mister said, “This is a wake up call for industry. This is a paradigm-changing moment as far as how consumers view the industry.”
Mr. Blumenthal said this moment might serve as an opportunity for the herbal products industry to reexamine its supply chain and its commitment to consumers.
Internal and independent third-party tests demonstrated that the company’s products contain all herbal extracts listed on their respective labels. In addition, a former senior FDA Good Manufacturing Practice (GMP) expert performed a comprehensive review of GNC’s manufacturing processes for the products at issue and found them to be in compliance with all applicable requirements. Accordingly, GNC has restored its full assortment of Herbal Plus products to all GNC stores in New York State.
GNC said it will expand its testing processes deeper into its supply chain by leading ongoing industry efforts to integrate source material traceability standards including DNA barcoding where appropriate (prior to extraction processes) and enhance other aspects of its operations to provide consumers greater confidence in its products. The company said it believes these measures will result in the adoption of stricter minimum standards across the broader industry.
“As our testing demonstrated, and this agreement affirms beyond any doubt, our products are not only safe and pure but are in full compliance with all regulatory requirements,” said Michael G. Archbold, CEO of GNC. “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. 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. This is good for consumers, good for the industry, and good for GNC.”
GNC has preserved the specific product lots of the five products that were the subject of this inquiry for use in defending the company against lawsuits that have been filed subsequent to the NY AG’s Feb. 2 cease-and-desist letter, despite the fact that there is no prohibition against the sale of such products. The company said it believes these lawsuits are completely without merit and will defend itself aggressively. Identical products to those that have been preserved remain available for sale to consumers at GNC stores in New York State.
What’s in the Agreement?
According to the NY AG office, in addition to authentication of plant source materials, the agreement includes the following measures:
Broad Testing For Contaminants: GNC will implement a sweeping, randomized testing protocol for the eight most common allergens—defined by 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 products. To do this, GNC will not only require its suppliers to implement this testing protocol, but will also perform testing itself on finished products, using scientifically validated methods. In addition, GNC will 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 AG’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 AG’s office to verify compliance with this agreement without the necessity for a subpoena.
GNC’s Reasoning
Many have questioned what GNC’s agreement means for the broader industry, and why the company committed to more extensive testing after it was determined its products were safe and compliant with regulatory requirements.
GNC’s Mr. Archbold issued a letter to industry defending the company’s actions. In that correspondence, he said the following language was critical to reaching an agreement: “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.”
In addition, he said “going above and beyond” cGMPs would reassure confidence among supplement users.
While DNA barcoding of finished extract product was not an appropriate test, he said the method may play a role in identifying source materials earlier in the production process. This added step, he said, will not change GNC’s products, but rather provide greater assurance to customers.
He added that random allergen testing not only assures the integrity of the supply chain, but also acts as additional validation of existing quality systems. Lastly, Mr. Archbold stressed that GNC and the NY AG “disagree on the sufficiency of federal rules and testing requirements and their relationship to state consumer protection laws.” Nonetheless, he said the company has chosen to work with the NY AG to continue to assure the highest quality products for consumers.
Mr. Archbold concluded the letter suggesting the industry should not fear more rigorous testing methods, but rather embrace them to ensure consumer trust.
Reactions & Implications
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), acknowledged the difficult position the NY AG investigation has put retailers in, as they face consumer confidence concerns and class-action lawsuits. However, he cautioned the industry against settling and making promises to the AG based on a flawed study that hasn’t been released publicly—and probably never will be.
The 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,” he said.
DNA barcode testing is an emerging analytical method, according to Mark Blumenthal, founder and executive director of the American Botanical Council (ABC). However, it is only one tool in a toolbox. One notable limitation of DNA barcode testing, for example, is that it won’t identify the plant part (i.e., root, stem, leaf, etc.)
“One of my main concerns is that science is being misapplied,” he said, adding that it would be extremely unfortunate if the NY AG’s misinformation and misuse of technology ultimately caused consumers to abandon legitimate health products.
While adulteration is still an issue for botanicals, Mr. Blumenthal has been spearheading an international program whose mission relates to education, scientific research, and quality of botanical dietary ingredients and related plant-derived materials. The ABC-AHP-NCNPR Botanical Adulterants Program is a consortium of independent non-profit organizations: the American Botanical Council, the American Herbal Pharmacopoeia (AHP) and the National Center for Natural Products Research (NCNPR) at the University of Mississippi.
AGs Appeal to Congress
Meanwhile, 14 state attorneys general sent a letter to Congress on April 2 urging leadership to investigate the supplement industry and to consider “a more robust oversight role” for FDA. The letter claimed the safety and efficacy of dietary supplements is a matter of “deep public concern across the country,” and stated: “The FDA has long been aware of problems in the dietary and herbal supplement supply chain, from dubious ingredient sourcing to a failure to carry out proper testing on finished products.”
The coalition’s letter requested that Congress act in concert with FDA to explore and address the following:
1. The adequacy and effectiveness of existing quality assurance measures for verifying the source, identity, purity, potency, and quality of ingredients and fillers;
2. The adequacy and effectiveness of existing regimes for verifying the identity, composition, purity, potency, and quality of the finished products sold by domestic manufacturers and retailers;
3. The degree to which product labels and marketing, including use of the terms “natural,” “herbal,” and “extract,” mislead consumers about the contents of herbal and dietary supplements and whether the FDA should develop standards and restrictions governing their use;
4. The extent to which Congress should mandate, or direct FDA to develop, enhanced, uniform, industry-wide quality assurance and verification regimes to guarantee the source, identity, purity, and potency of materials incorporated into herbal and dietary supplements; and,
5. The extent to which Congress should mandate, or direct, FDA to develop enhanced manufacturing and supply chain management requirements for the industry to guarantee the safety and efficacy of the finished herbal and dietary supplements.
CRN’s Mr. Mister said it was noteworthy that only 15 AGs had signed the letter, as it was certainly presented to all 53. CRN has been actively meeting with state AGs to discuss the matters at hand. “We are gratified that the concerns go away once we’re given the opportunity to fully explain the issue,” he said. Additionally, the letter was addressed to the Senate Commerce committee, as opposed to the Health, Education, Labor and Pensions committee.
Still, in light of fallout from all the negative attention, Mr. Mister said, “This is a wake up call for industry. This is a paradigm-changing moment as far as how consumers view the industry.”
Mr. Blumenthal said this moment might serve as an opportunity for the herbal products industry to reexamine its supply chain and its commitment to consumers.
