Sean Moloughney, Editor02.25.15
Expanding his investigation into the herbal dietary supplement industry, New York Attorney General Eric Schneiderman has formally requested ingredient and quality control information from four product manufacturers: Pharmavite LLC (Mission Hills, CA), NBTY Inc. (Ronkonkoma, NY), Nature’s Way Products Inc. (Lehi, UT) and Nutraceutical Corp. (Park City, UT).
Letters sent to each company Feb. 23, stated: “The scientific community, public health officials, and others have raised serious doubt about the steps taken to ensure the safety and efficacy of the herbal dietary supplements taken daily by millions of Americans. As part of a broader investigation, NY AG is reviewing the sufficiency of the measures manufacturers and retailers are taking to independently assess the validity of their representations and advertising in connection with the sale of herbal supplements. We seek your company’s cooperation as an herbal dietary supplement manufacturer to address these issues and, ultimately, to resolve any deficiencies.”
The letters went on to request information and documents related to the supply and manufacture of herbal ingredients and finished dietary supplements sold in New York since 2013, including standard operating procedures, quality control measures, analytical testing, label claims substantiation, and adverse event reporting. The letter requested delivery of documentation by Friday, March 13.
Gone Fishing?
Calling the request “a massive fishing expedition,” Loren Israelsen, president of the United Natural Products Alliance (UNPA), Salt Lake City, UT, said he was “mystified” by the AG’s investigation.
“The expansion of the NY AG’s botanical products investigation now includes four highly respected industry companies—all stalwarts in the industry—for no apparent reason. There are no indications of any quality problems and no allegations. It is a gross injustice that simply by virtue of these companies being named, suggesting that they are noncompliant, this latest action places a pall of suspicion over these companies.”
He continued: “This is a massive fishing expedition and highly disruptive to these companies’ daily operations that are all part of the clearly defined federal regulatory structure for dietary supplements. We continue to be mystified as to why the NY AG has chosen to do FDA’s job. We regret to see this misplaced use of the AG’s time and taxpayer money and the red tape created for reputable supplement companies that are simply trying to do the right thing.”
‘Perplexing’
All of the information requested from manufacturers can be accessed by FDA, according to Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), Washington, D.C., who previously served as director of the Division of Dietary Supplement Programs at FDA.
“The federal government is fully equipped to regulate dietary supplements, and goes to great lengths to ensure consumer and public health is protected. If the FDA finds issues with manufacturers, it swiftly and resolutely takes action against those firms. In my time at the agency, we were not shy about going after those who put consumers at risk.”
Dr. Fabricant said it’s “perplexing” as to why Mr. Schneiderman continues to pursue dietary supplement regulatory matters, “which do not fall within his authority and are already handled by the regulators within the federal government. The attorney general seems more motivated by generating headlines and plaintiff’s cases than by protecting the public health.”
On Feb. 2 the attorney general sent cease-and-desist letters to major retailers (GNC, Target, Walmart and Walgreens), asking them to remove products from their shelves, alleging herbal supplement products either could not be verified to contain the labeled substance through DNA barcoding tests, or were found to contain ingredients not listed on the labels.
“The Natural Products Association has serious concerns over the scientific basis for that recall,” said Dr. Fabricant.
On Feb. 16 the AG then shifted attention away from DNA testing, issuing subpoenas that requested substantiation of structure/function claims for the herbal products in question.
“These actions set a dangerous precedent not just for dietary supplement retailers but for the entire retail market, including manufacturers and ingredient suppliers,” said Dr. Fabricant. “If actions such as this are permitted, they will surely branch out to other commodities and industries. As the attorney general’s actions evolve, it’s imperative that we continue demanding transparency and requesting his office release the study data. NPA continues with our efforts to hold the attorney general accountable via our grassroots outreach, and we encourage all retailers and manufacturers in all industries to speak up with resolve on this issue.”
Dr. Fabricant reiterated that NPA is “committed to quality, and when that quality comes into question, we take that very seriously. That is why the organization boasts former FDA personnel on staff and partners with trusted brands such as UL to ensure industry members are fully educated on Good Manufacturing Practices and other quality control measures to make sure only the best products are reaching consumers. If Attorney General Schneiderman has questions on quality and what the industry is doing to guarantee safe and effective supplements, we welcome the opportunity to discuss this with him.”
Senators Request FDA Response
Senators Orrin Hatch (R-UT) and Martin Heinrich (D-NM) sent a letter to FDA on Feb. 18 to ask if DNA testing is an appropriate method to identify botanical ingredients in supplements.
"Attorney General Schneiderman has refused to make the test results and the details of the study methodology public, and questions about the appropriateness of DNA testing for herbal extracts have been raised that merit consideration," the letter stated.
"The question at the heart of this matter is whether DNA barcoding methodology is fit for the purpose of identifying DNA in botanical extracts found in dietary supplements,” the letter continued. “It is our understanding that the process of extracting an herb's phytochemicals used for finished products can either damage, destroy or simply leave behind the DNA.”
Letters sent to each company Feb. 23, stated: “The scientific community, public health officials, and others have raised serious doubt about the steps taken to ensure the safety and efficacy of the herbal dietary supplements taken daily by millions of Americans. As part of a broader investigation, NY AG is reviewing the sufficiency of the measures manufacturers and retailers are taking to independently assess the validity of their representations and advertising in connection with the sale of herbal supplements. We seek your company’s cooperation as an herbal dietary supplement manufacturer to address these issues and, ultimately, to resolve any deficiencies.”
The letters went on to request information and documents related to the supply and manufacture of herbal ingredients and finished dietary supplements sold in New York since 2013, including standard operating procedures, quality control measures, analytical testing, label claims substantiation, and adverse event reporting. The letter requested delivery of documentation by Friday, March 13.
Gone Fishing?
Calling the request “a massive fishing expedition,” Loren Israelsen, president of the United Natural Products Alliance (UNPA), Salt Lake City, UT, said he was “mystified” by the AG’s investigation.
“The expansion of the NY AG’s botanical products investigation now includes four highly respected industry companies—all stalwarts in the industry—for no apparent reason. There are no indications of any quality problems and no allegations. It is a gross injustice that simply by virtue of these companies being named, suggesting that they are noncompliant, this latest action places a pall of suspicion over these companies.”
He continued: “This is a massive fishing expedition and highly disruptive to these companies’ daily operations that are all part of the clearly defined federal regulatory structure for dietary supplements. We continue to be mystified as to why the NY AG has chosen to do FDA’s job. We regret to see this misplaced use of the AG’s time and taxpayer money and the red tape created for reputable supplement companies that are simply trying to do the right thing.”
‘Perplexing’
All of the information requested from manufacturers can be accessed by FDA, according to Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association (NPA), Washington, D.C., who previously served as director of the Division of Dietary Supplement Programs at FDA.
“The federal government is fully equipped to regulate dietary supplements, and goes to great lengths to ensure consumer and public health is protected. If the FDA finds issues with manufacturers, it swiftly and resolutely takes action against those firms. In my time at the agency, we were not shy about going after those who put consumers at risk.”
Dr. Fabricant said it’s “perplexing” as to why Mr. Schneiderman continues to pursue dietary supplement regulatory matters, “which do not fall within his authority and are already handled by the regulators within the federal government. The attorney general seems more motivated by generating headlines and plaintiff’s cases than by protecting the public health.”
On Feb. 2 the attorney general sent cease-and-desist letters to major retailers (GNC, Target, Walmart and Walgreens), asking them to remove products from their shelves, alleging herbal supplement products either could not be verified to contain the labeled substance through DNA barcoding tests, or were found to contain ingredients not listed on the labels.
“The Natural Products Association has serious concerns over the scientific basis for that recall,” said Dr. Fabricant.
On Feb. 16 the AG then shifted attention away from DNA testing, issuing subpoenas that requested substantiation of structure/function claims for the herbal products in question.
“These actions set a dangerous precedent not just for dietary supplement retailers but for the entire retail market, including manufacturers and ingredient suppliers,” said Dr. Fabricant. “If actions such as this are permitted, they will surely branch out to other commodities and industries. As the attorney general’s actions evolve, it’s imperative that we continue demanding transparency and requesting his office release the study data. NPA continues with our efforts to hold the attorney general accountable via our grassroots outreach, and we encourage all retailers and manufacturers in all industries to speak up with resolve on this issue.”
Dr. Fabricant reiterated that NPA is “committed to quality, and when that quality comes into question, we take that very seriously. That is why the organization boasts former FDA personnel on staff and partners with trusted brands such as UL to ensure industry members are fully educated on Good Manufacturing Practices and other quality control measures to make sure only the best products are reaching consumers. If Attorney General Schneiderman has questions on quality and what the industry is doing to guarantee safe and effective supplements, we welcome the opportunity to discuss this with him.”
Senators Request FDA Response
Senators Orrin Hatch (R-UT) and Martin Heinrich (D-NM) sent a letter to FDA on Feb. 18 to ask if DNA testing is an appropriate method to identify botanical ingredients in supplements.
"Attorney General Schneiderman has refused to make the test results and the details of the study methodology public, and questions about the appropriateness of DNA testing for herbal extracts have been raised that merit consideration," the letter stated.
"The question at the heart of this matter is whether DNA barcoding methodology is fit for the purpose of identifying DNA in botanical extracts found in dietary supplements,” the letter continued. “It is our understanding that the process of extracting an herb's phytochemicals used for finished products can either damage, destroy or simply leave behind the DNA.”
