Issue:
112
Page: 60-61
NBTY Signs Agreement with New York Attorney General Regarding DNA Testing of Herbs
NY AG finds no evidence for non-compliance with cGMPs
by Stefan Gafner, PhD
HerbalGram.
2016; American Botanical Council
On September 20, 2016, NBTY, Inc., the largest dietary
supplement manufacturer in the United States, signed an agreement with the
Office of the New York Attorney General (NY AG) to develop and incorporate
enhanced herbal authentication methods, including DNA barcoding, into its
quality control procedures.1,2
The agreement comes more than 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 ingredients listed on the label. The
allegations were based on the results of a controversial DNA barcoding
approach, which suggested that only five of the 24 commercial products analyzed
contained DNA of the labeled species. These results led the NY AG to demand
that the four retailers remove the products from their shelves in the state of
New York.3
The accuracy of the results, however, was immediately
questioned by experts in the field of botanical ingredient authentication.4,5
Although details of the method used were not released, these experts indicated
that because the majority of the products were made from herbal extracts, which
contain plant DNA that is frequently fragmented or degraded, DNA barcoding was
unlikely to provide useful or definitive results upon which to base regulatory
action. The investigation reported finding DNA from species in the following
genera: Oryza (found in 19 samples), which includes rice (O. sativa, Poaceae); Allium
(in nine samples), which includes garlic (A. sativum, Amaryllidaceae) and onion
(A. cepa); and Dracaena (Asparagaceae; found in seven samples), which includes
popular non-medicinal houseplants. These findings strongly suggest that the DNA
barcoding results were due to cross-contamination. In addition, one valerian (Valeriana
officinalis, Caprifoliaceae) sample allegedly contained saw palmetto (Serenoa
repens, Arecaceae) DNA, again raising the question of cross-contamination.6
The results of the investigation and subsequent
cease-and-desist orders issues by the NY AG were publicized in national
newspapers, including The New York Times and The Washington Post.7-9 Despite
the apparent use of an inappropriate and inadequate test method, some news
organizations did not question the results and were highly critical of the
dietary supplement industry. A widely distributed Associated Press article
published shortly after the NY AG’s initial announcement did attempt to cover
the growing controversy surrounding the NY AG’s reliance on only the DNA
barcoding analytical method.10 A detailed review on the investigation by the NY
AG was published in HerbalGram issue 106.11
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 supplements in question were produced and labeled in
accordance with current good manufacturing practices (cGMPs), as required by
federal law (i.e., none of the supplements were found to be deficient,
adulterated, mislabeled, or a potential hazard to public health, as initially
alleged by the NY AG).3,7,8
On March 27, 2015, in a highly publicized development,
supplement retailer GNC signed an agreement with the NY AG to implement
DNA-barcoding testing methods on all botanical ingredients in its dietary
supplements before such ingredients were processed into extracts.12
While NBTY maintains that there are currently no
scientifically valid testing methods for DNA barcoding-based identification of
botanical ingredients, it has agreed to incorporate DNA barcoding into its
quality control testing procedures no later than September 20, 2017, for at
least 12 distinct botanical species (the 12 herbs are not 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 September 20, 2018.
In addition, NBTY pledged to invest $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 2015.12
The agreement terminates the investigation by the NY AG into
NBTY’s supplement manufacturing processes, and it will cease to be in effect 36
months from the date of the agreement. A resolution between the NY AG and
Target still appears to be pending.
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 is a promising technology, the uncritical use of DNA
barcoding has led to an unfortunate situation in which regulatory action has
been 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.
* According to the agreement, existing scientifically valid
DNA barcoding methods are those that meet one or more of the following
criteria:
- DNA barcoding methods that are incorporated in a monograph
associated with the relevant ingredient by the United States Pharmacopeia or
the American Herbal Pharmacopoeia.
- The US Food and Drug Administration accepts or endorses the
use of DNA barcoding, either as a standalone method or part of a multi-method
protocol, as a scientifically valid method for confirming the identity of the
relevant ingredient.
- Any US industry group in which NBTY is a corporate member identifies
DNA barcoding as a valid or appropriate method for confirming the authenticity
of the relevant ingredient, as either a standalone method or part of a
multi-method protocol.
- Upon review of scientific literature and industry practice,
NBTY or its Herbal Authenticity Program independently recognizes that reliable
and scientifically valid DNA barcoding is available for that ingredient.
** cGMPs pertain to manufacturers and distributors of
dietary supplements but not to the producers and suppliers of the ingredients
used in the production of finished products. Several recent herb and dietary
supplement industry initiatives have focused on creating guidelines for
manufacturers to require of suppliers in the absence of federally mandated
practices for ingredient suppliers.
References
-
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 October 11, 2016.
- 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 October 12,
2016.
- 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:
www.ag.ny.gov/press-release/ag-schneiderman-asks-major-retailers-halt-sales-certain-herbal-supplements-dna-tests.
Accessed October 11, 2016.
- Harbaugh
Reynaud DT, Mishler BD, Neal-Kababick J, Brown PN. The Capabilities and
Limitations of DNA Barcoding of Botanical Dietary Supplements [white paper].
Richmond CA: AuthenTechnologies; March 2015. Available at:
https://gallery.mailchimp.com/2d47ec72fa1542de734a46f71/files/Reynaud_DNA_Barcoding_White_Paper.pdf.
Accessed October 11, 2016.
- Is DNA
barcode testing appropriate for the conclusions reached by the New York
Attorney General? Here’s what some of the experts say... . Council for
Responsible Nutrition website. Available at: www.crnusa.org/NYAG/quotes.html.
Accessed October 11, 2016.
- Parveen I,
Gafner S, Techen N, Murch SJ, Khan IA. DNA barcoding for the identification of
botanicals in herbal medicine and dietary supplements: strengths and
limitations. Planta Med. 2016;82(14):1225-1235. DOI:10.1055/s-0042-111208.
Available at:
www.thieme-connect.com/products/ejournals/pdf/10.1055/s-0042-111208.pdf.
Accessed October 12, 2016.
- 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 October 11, 2016.
- 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 October 11, 2016.
- Kaplan S.
GNC, Target, Wal-Mart, Walgreens and accused of selling adulterated ‘herbals’. Washington
Post. February 3, 2015. Available at: www.washingtonpost.com/news/morning-mix/wp/2015/02/03/gnc-target-wal-mart-walgreens-accused-of-selling-fake-herbals/.
Accessed October 11, 2016.
- Esch M. Supplements industry derides NY attorney general’s
DNA tests. February 10, 2015. Seattle Post-Intelligencer website. Available at: www.seattlepi.com/news/medical/article/Supplements-industry-derides-NY-attorney-6069689.php.
Accessed March 9, 2015.
- Smith T. The Supplement Saga: A Review of the New York
Attorney General’s Herbal Supplement Investigation. HerbalGram. 2015;106:44-55.
Available at:
http://cms.herbalgram.org/herbalgram/issue106/hg106-FEAT-NYAG.html. Accessed
October 12, 2016.
- 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:
www.ag.ny.gov/press-release/ag-schneiderman-announces-agreement-gnc-implement-landmark-reforms-herbal-supplements.
Accessed October 11, 2016.
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