“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,” said Schneiderman in his letters.
“As part of a broader investigation, NYAG 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.”
In its letters to Nature’s Way, NBTY, Nutraceutical Corp., and Pharmavite, The NY AG’s office has requested a number of documents and additional information, including
1. A detailed spreadsheet listing herbal dietary supplements your company or any of its subsidiaries sold in New York on or after January 1, 2013,
2. Copies of all labels used since January 1, 2013 for all of these supplements
3. Copies of all manufacturing, licensing, or sales contracts executed, or in effect, at any time since January 1, 2013 for these supplements,
4. Copies of all documents reflecting standards or procedures in place or followed for those products since 01/01/13
5. A detailed description of quality control measures, including but not limited to the implementation of Good Farming and Collection Practices (GACPs) or Current Good Manufacturing Practices (CGMPs).
6. A detailed description of all testing methods used on finished products to substantiate affirmative claims, such as “gluten free” or “hypoallergenic.”
7. Copies of all documents received from or sent to the FDA on or after 01/01/13, including but not limited to all Form 483s and the responses thereto.
8. Copies of all Bioterrorism Registration documents
9. Copies of all reports, complaints, or other documents reflecting adverse health
Matt Mittenthal, a spokesperson for the NY AG's office, said: "Attorney General Schneiderman is committed to ensuring that the roughly 150 million Americans who use herbal supplements know what is in the products they are consuming.
"It's important for both retailers and manufacturers to verify the contents of the products they sell so consumers can be protected against deceptive claims on packaging, and against potentially dangerous reactions to undisclosed ingredients."
NBTY: "We are confident that our products meet our label claims"
A spokesperson for NBTY told us that the company appreciates the NY State Attorney General’s office for helping to ensure that the manufacturers of supplements are accountable for the content and quality of what they are producing, and NBTY is fully cooperating with this request for information. "We are confident that our products meet our label claims and will gladly test any that are in question.
"Our products go through rigorous testing protocols that fully adhere to Good Manufacturing Practices (GMPs)to ensure their efficacy. Our raw materials are authenticated upon receipt and finished products are tested to ensure potency as part of our routine testing procedures for every lot of product. We also have more than 300 quality control professionals whose primary responsibility within the company is to take actions that ensure our quality standards are maintained.
"We stand by these strict and proven GMPs, which ensure quality throughout every part of the supply chain process, from the day we get the raw materials to the day our bottled products hit store shelves."
‘Just ask the FDA’
Daniel Fabricant, PhD, CEO and executive director of the Natural Products Association and former director of the Division of Dietary Supplement Programs at the Food and Drug Administration (FDA), said that all of the information the AG is requesting from these manufacturers can be accessed by the FDA.
“The federal government is fully equipped to regulate dietary supplements, and goes to great lengths to ensure consumer and public health is protected,” said Dr Fabricant. “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 are risk.
“It is perplexing as to why Attorney General Schneiderman continues to use resources to address dietary supplement 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.”
The winds of change
Three weeks have passed since AG Schneiderman sent cease and desist letters to four leading retailers, and a week since the AG shifted direction and focused attention away from DNA in botanical extracts and toward structure/function claims.
“These actions set a dangerous precedent not just for dietary supplement retailers but for the entire retail market, including manufacturers and ingredient suppliers,” said 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.”
“The AG needs to have a deep and meaningful conversation with the FDA”
Steve Mister, President and CEO of the Council for Responsible Nutrition, which includes NBTY and Pharmavite as members, said he is confident that CRN members will comply with the AG’s requests but added that it is an “unnecessary regulatory burden for them to gather all of this information”.
Mister said that he was initially pleased, however, to see the AG move away from DNA testing, which means perhaps he understands it was the wrong test to be using. AG Schneiderman is also now asking the kinds of questions that FDA has been asking for years, he said.
“FDA inspects all of these facilities, and they have been under GMPs since 2008. We would encourage the NY Attorney General to have a deep and meaningful conversation with the FDA.”
CRN is continuing its efforts in Albany, DC, and with the other 49 Attorneys General around the country, said Mister, to explain the limitations of DNA barcoding, and the requirements to substantiate the quality of the products. “The industry is indeed regulated and producing quality products for consumers,” he said.
“The down side of all of this is the very public way it’s been played out and hurting consumer confidence in the industry.”
Why has the NY AG chosen to do FDA’s job?
Loren Israelsen, UNPA president, said: "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.
“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, taxpayer money and red tape for reputable supplement companies that are simply trying to do the right thing.”
The Senators weigh in
Senators Orrin Hatch, R-UT, and Martin Heinrich, D-NM, have stepped in to the issue, and sent a letter last week to FDA Commissioner Hamburg to inquire about the DNA barcode testing that AG Schneiderman used as the scientific basis for his request.
The letter, which can be viewed on the NPA website, requests the FDA to respond to a number of questions, including:
1. Do federal regulations require manufacturers to identity test incoming material for their products, do the regulations require manufacturers to also test their finished products to ensure identity, purity, strength and composition?
2. Does FDA recognize DNA barcoding for botanical extracts? Would DNA barcoding alone satisfy federal regulations?
3. Does FDA recommend the use of FDA barcoding?
4. Do federal laws and regulations require food labeling (including dietary supplements) to identify all ingredients? Are trace amounts allowed in a product without being labeled? Are plant materials used for excipients allowed in supplements?