NBTY Signs Agreement with New York Attorney General to Begin Using DNA Testing of Herbs despite No Evidence for cGMP Non-Compliance

 

Note: An extended version of the story was published in HerbalGram 112.

 

On September 20, 2016, Simon G. Brandler, Senior Advisor & Special Counsel to New York state Attorney General (NY AG) Eric T. Schneiderman, and Steven Cahillane, CEO of NBTY, the largest dietary supplement manufacturer in the United States, signed an agreement in which NBTY agreed to develop and incorporate enhanced herbal authentication methods, including DNA barcoding.^1,2

 

The agreement comes over 18 months after an investigation initiated by the NY AG in February 2015 alleged that four out of five herbal dietary supplement products sold at retailers GNC, Walgreens, Walmart, and Target did not contain the ingredients listed on the label based on a controversial DNA barcoding approach. These results led the NY AG to demand that the four retailers remove the products from their shelves in stores in the state of New York.³

 

NBTY, which had contract-manufactured herbal supplements sold at Walgreens and Walmart under the retailers’ respective brands, responded to and fully cooperated with the NY AG’s investigation, providing documentation confirming that the production and labeling of the herbal supplements in question were in accordance with current Good Manufacturing Practices (cGMPs), as required under federal law. That is, none of the botanical supplements tested by the NY AG, which were produced by NBTY, were found to be deficient, adulterated, mislabeled, or a potential hazard to public health, as initially alleged by the NY AG when he issued the press release announcing his investigation on February 3, 2015, and as reported in The New York Times that same day.^3-5

 

On March 27, 2015, in a highly publicized development, supplement manufacturer and retailer GNC signed a similar agreement with the NY AG in which the company agreed to implement DNA-barcoding testing methods on all botanical ingredients in its dietary supplements before such ingredients were processed into botanical extracts.⁶ At the same time, the NY AG acknowledged that none of the GNC products in question were adulterated.

 

While NBTY maintains that there are currently no scientifically valid testing methods for DNA barcoding-based identification of botanical ingredients, NBTY has agreed to incorporate DNA barcoding in its quality control testing procedures no later than 12 months after signing the agreement, and for at least 12 distinct botanical species (the 12 herbs are not specifically named in the agreement). Also as part of the agreement, NBTY will implement DNA barcoding authentication of all botanical ingredients for which scientifically valid methods exist no later than two years after the date of signing the agreement.

 

NBTY also agreed to invest US $250,000 to foster genetic authenticity research and education; to partner with academic institutions (e.g., Cornell University) to improve transparency and traceability of botanical dietary supplements; to work with industry organizations in the development of supplier cGMPs*; and to have their manufacturing facilities audited by a third-party accreditation body. Also included in the agreement is a commitment to allergen labeling and a campaign to improve consumer information, similar to the requirements outlined in the agreement between the NY AG and GNC from March 2015.⁶

 

The agreement terminates the investigation by the NY AG into the NBTY dietary supplement manufacturing processes, and will cease to be in effect 36 months after its signing. A resolution between the NY AG and Target appears to be pending still.

 

Comment: Many members of the botanical dietary supplement industry have shown their willingness to embrace new analytical techniques for improved quality control processes as long as they are fit for the intended purpose, with the goal to provide the highest quality product for consumers; while DNA-based authentication has promise, the inappropriate use of DNA barcoding led to this unfortunate situation, where regulatory action is based on erroneous results. This investigation is an example of a lack of understanding by regulatory agencies of the manufacturing processes involved in the production of botanical dietary supplements and of scientifically valid testing methods.

 

*Current cGMPs required by federal law pertain to manufacturers and distributors of dietary supplements but not to producers and suppliers of the dietary ingredients used in the production of finished dietary supplement products.

 

References

1.     A.G. Schneiderman Announces Major Nationwide Agreement with NBTY, Herbal Supplement Maker for Walgreens and Walmart [press release]. Albany, NY: New York State Attorney General’s Office; September 28, 2016. Available at: http://ag.ny.gov/press-release/ag-schneiderman-announces-major-nationwide-agreement-nbty-herbal-supplement-maker. Accessed December 12, 2016.

2.     Schneiderman ET. Agreement between the New York State Office of the Attorney General (“NYAG”) and NBTY, Inc. (“NBTY”) [letter]. Albany, NY: New York State Attorney General’s Office; September 20, 2016. Available at: https://ag.ny.gov/sites/default/files/nbty_agreement.pdf. Accessed December 12, 2016.

3.     A.G. Schneiderman Asks Major Retailers to Halt Sales of Certain Herbal Supplements as DNA Tests Fail to Detect Plant Materials Listed on Majority of Products Tested [press release]. Albany, NY: New York State Attorney General’s Office; February 3, 2015. Available at: http://www.ag.ny.gov/press-release/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests. Accessed December 12, 2016.

4.     O’Connor A. New York Attorney General targets supplements at major retailers. New York Times. February 3, 2015. Available at: http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/. Accessed December 12, 2016.

5.     O’Connor A. What’s in those supplements? New York Times. February 3, 2015:A1. Available at: http://well.blogs.nytimes.com/2015/02/03/sidebar-whats-in-those-supplements/. Accessed December 12, 2016.

6.     A.G. Schneiderman Announces Agreement with GNC to Implement Landmark Reforms for Herbal Supplements [press release]. Albany, NY: New York State Attorney General’s Office; March 30, 2015. Available at: http://www.ag.ny.gov/press-release/ag-schneiderman-announces-agreement-gnc-implement-landmark-reforms-herbal-supplements. Accessed December 12, 2016.