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Post date: September 28 2016

A.G. Schneiderman Announces Major Nationwide Agreement With NBTY, Herbal Supplement Maker for Walgreens And Walmart

News from Attorney General Eric T. Schneiderman

September 28, 2016

New York City Press Office / 212-416-8060
Albany Press Office / 518-776-2427
Twitter: @AGSchneiderman 


Leading Supplements' Manufacturer NBTY, Inc., To Use DNA Barcoding To Authenticate Herbal Ingredients For First Time; Conduct Tests To Detect Peanuts, Soy, And Other Allergens; Invest $250k In Herbal Genetic Research; Require Ingredient Makers To Submit To Third-Party Certification; And Double On-Site Audits Of Major Suppliers.  

Reforms – Which Exceed Permissive FDA Standards – Follow A.G. Investigation Finding Majority Of Tested Supplements From Walgreens, Walmart, And Others Didn’t Contain Detectable DNA From Listed Plant; NBTY Follows GNC And Nature’s Way As Third Major Supplement Manufacturer To Initiate Key Industry Reforms  

Schneiderman: I Urge the Rest Of The Herbal Supplement Industry To Seize This Moment And Go Much Further To Protect Consumers

NEW YORK – Attorney General Eric T. Schneiderman today announced a major agreement with Long Island-based herbal supplement manufacturer NBTY to implement new quality control measures for all herbal supplements sold nationwide to confirm their authenticity, ensure their purity, and educate consumers about their chemical content. The Attorney General’s settlement with NBTY is the third such agreement to require DNA barcoding and other testing, labeling, and manufacturing reforms to protect supplement consumers that exceed the more permissive FDA requirements. Advancing under New York’s strong consumer protection laws, the Attorney General previously reached accords with GNC and Nature’s Way.

“When consumers take an herbal supplement, they should be able to do so confident that the plant on the label is the plant in the bottle, and that every reasonable precaution was taken to ensure the product’s authenticity and purity,” said Attorney General Schneiderman. “Consumers can only have that confidence if the companies that sell herbal supplements employ the best and most reliable testing measures for combating fraud and ruling out dangerous allergens. I am pleased that NBTY has joined GNC and Nature’s way and agreed to increase transparency, improve quality control, and do more to protect consumers, and I urge the rest of the herbal supplements industry to do the same.”

Under today’s agreement, NBTY will phase in DNA barcoding on herbal ingredients within two years. By the end of year one, NBTY will test all ingredients derived from no fewer than 12 distinct species. By the end of year two, it will extend testing to all herbal ingredients with a reliable and scientifically valid barcode. The agreement also requires NBTY to implement an annual testing protocol to detect allergens (peanuts, milk, soy, eggs, and wheat) in finished herbal products; to double the number of on-site audits of major ingredient suppliers; to mandate that all NBTY “active” ingredient suppliers—which are exempt from FDA rules—receive certification from a third-party accreditation body and abide by generally accepted manufacturing practices; and to invest no less than $250,000 in herbal authenticity genetic research in the first year. In addition, NBTY will take concrete steps to partner with Cornell University and other major research institutions to further the transparency and traceability of herbal dietary supplements, including through DNA barcoding.

DNA barcoding is a technique used to authenticate organic materials using unique reference sequences of DNA, a reliable scientific technique for verifying the identity and presence of plant species.

In February, 2015, Attorney General Schneiderman sent cease-and-desist letters to GNC, Target, Walgreens, and Walmart, after a study commissioned by the office failed to detect identifiable genetic material for the plants depicted on the labels in most of the four retailers’ herbal supplement products. These included NBTY-manufactured supplements sold at Walgreens and Walmart. The study further detected DNA associated with plants not listed on the labels, as well as the presence of potential allergens. In launching his investigation, the Attorney General raised concerns about the measures in place to ensure the authenticity and purity of herbal supplements – which are taken by more than half of all American adults – and the sufficiency of federal standards regulating this $60 billion worldwide industry.

Previous scientific studies had uncovered substitution and adulteration in herbal supplements sold by various U.S. manufacturers, including supplement derived from bilberry, saffron, skullcap, black cohosh, saw palmetto, and many others. The off-label substitutes are typically cheaper and, in certain cases, have been linked to serious medical consequences, including liver failure. Contamination separately poses a significant danger to those who have food allergies or take medication – and there have been a number of examples of supplements endangering consumer safety. A 2013 outbreak of hepatitis that struck at least 72 people in 16 states was traced to a tainted supplement.

In March, 2015, Attorney General Schneiderman secured a landmark agreement with GNC requiring the company to perform DNA barcoding on the “active” plant ingredients used in its products, and to implement a series of other measures to enhance the authenticity and purity of their products. In May, 2015, Attorney General Schneiderman issued a joint statement with a major supplement industry trade group, endorsing the application of DNA barcoding as part of a multi-faceted approach to assuring authenticity and identifying substitution.

In September, 2015, Attorney General Schneiderman reached an accord with another manufacturer, Nature’s Way, which agreed to improve the manufacturing and marketing of an herbal supplement derived from devil’s claw (Harpagophytum procumbens), and announced that it would employ DNA barcode testing across its major herbal products lines. The Nature’s Way agreement came after a DNA barcoding study from the New York Botanical Garden concluded that the devil’s claw supplements sold by Nature’s Way and other manufacturers contained a cheaper, less desirable species.

Today’s agreement with NBTY builds on the earlier agreements to further reform the herbal supplements industry. As with the office’s previous agreement with GNC, the agreement with NBTY notes that the FDA does not mandate the use of DNA-based technologies, and that there is no evidence that NBTY did not administer the minimum testing procedures the FDA requires. Instead, the investigation raised questions regarding the sufficiency of those requirements in relation to state consumer protection laws.

Specifically, the FDA allows companies to choose their own methodology to support their product claims. Given the existence of chemically-similar natural or synthetic substitutes, the Attorney General’s Office remains concerned that these alternate methodologies (typically chemical tests, which can be faked), standing alone, fail to provide acceptable assurance of the authenticity of herbal supplements. Moreover, current FDA regulations do not require testing to confirm that contamination, even with allergens, falls below relevant safety thresholds.

NBTY committed to implement DNA barcoding during herbal supplement production for the first time, to enhance other aspects of its operations, and act as catalyst within the industry to achieve vital reforms, as follows:

Authentication: NBTY will implement genetic barcoding of its herbal supplement products in two phases. In the first year, the company will barcode all herbal ingredients derived from 12 distinct plant species. In the second year, the company will barcode all remaining herbal ingredients in its products for which reliable and scientifically valid barcoding is available.

NBTY will invest $250,000 in herbal authenticity genetic research and education in the first year, including genetic research, and will take concrete steps to establish partnerships to improve the authenticity of herbal ingredients. Specifically, NBTY committed to partner with scientific institutions to further the development of uniform standards to authenticate herbs and contribute to the development of public genetic standards libraries. NBTY also committed to take steps to partner with Cornell University and other scientific institutions to further the transparency and traceability of herbal dietary supplements.

Good Manufacturing Practices: NBTY will actively support the establishment of Good Manufacturing Practices (GMP) Guidelines for Botanical Raw Material through industry associations to further authenticate and track plant material from the harvesting of plants to testing of the raw material. NBTY will also require that all “active” botanical ingredients supplied by NBTY’s herbal suppliers and used in Herbal Dietary Supplements will be manufactured in GMP compliant facilities and that their facilities be certified through a third-party accreditation body.

Supplier Site Risk Assessment: NBTY will pursue improvements in quality procedures with its suppliers designed to ensure the authenticity of the herbs from harvest to consumption. Specifically, NBTY will double its number of on-site audits from 12 to 24 to ensure proper herbal identification and authenticity testing for all lots received from herbal suppliers.

Allergen Detection and Labeling: Beginning in the next 12 months, NBTY will randomly test its herbal products on no less than an annual basis using a scientifically valid methodology for each of the following five, major allergens: (1) eggs; (2) milk; (3) wheat; (4) soy; and (5) peanut. NBTY will also upgrade its label text to ensure that supplement consumers with food allergies can make informed decisions, including by disclosing in easily understood terms all known major allergenic substances present in the manufacturing of herbal dietary supplements. 

Improve Consumer Information. Over the next two years, NBTY will develop educational materials, including scientific content to provide transparency from seed to shelf, including the chemical composition of any extracts, and advise consumers of potential interactions (if any) of the herbs or extracts. These materials will be developed by NBTYs Nutrition and Scientific Affairs Department and will be made via a consumer-facing website and as part of product information fact sheets made available to consumers and to retailers selling NBTY products.

The Attorney General’s review of industry practices to ensure the authenticity and purity of herbal supplements is ongoing.

The case is being handled by Executive Deputy Attorney General Marty Mack and Assistant Attorney General Deanna Nelson together with Simon Brandler, Senior Advisor and Special Counsel to the Executive Division. 

To see the copy of the agreement, click here.