Вы находитесь на странице: 1из 3

STATE OF NEW YORK

OFFICE OF THE ATTORNEY GENERAL


ERIC T. SCHNEIDERMAN

DIVISION OF REGIONAL AFFAIRS

ATTORNEY GENERAL

February 23, 2015

Ms. Connie Barry, CEO


Pharmavite LLC/Nature Made
P.O. Box 9606
Mission Hills, CA 91346
Re:

CertifiedReturn Receipt Requested


Facsimile: 818-221-6618

Herbal and Dietary Supplements Investigation

Dear Ms. Barry:


This letter constitutes a request for documents and information relating to an ongoing
investigation by the New York State Office of the Attorney General (NYAG) concerning the
authenticity and purity of herbal dietary supplements and associated marketing. 1
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, 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. We seek your companys cooperation as an herbal dietary supplement
manufacturer to address these issues and, ultimately, to resolve any deficiencies.
As you may know, NYAG recently commissioned an analysis that used DNA barcoding technology to
test several popular herbal dietary supplements sold at four retailers in New York State. The results were
shocking to many consumers and raise troubling legal questions. In addition to the frequent absence of genetic
material associated with the plant depicted on the label from the tested supplements, more than one in three
samples tested positive for the DNA of an unlisted plant species, potentially constituting a contaminated or
substituted product.
The contamination, substitution, or false labeling of herbal products would constitute a deceptive
business practice and, even more troublingly, could expose consumers to unacceptable health risks. Of
particular concern, companies selling herbal products may have inadequate proof that the substances come from
1

This investigation proceeds pursuant to various constitutional and statutory authorities, including but not limited to Executive Law
63(12) (fraud or illegality in the course of a business) and General Business Law Art. 22-b (deceptive business practices).

615 ERIE BOULEVARD WEST, SUITE 100, SYRACUSE, NY 13204 PHONE (315) 448-4800 FAX (315) 448-4853 WWW.AG.NY.GOV

February 23, 2015


Page 2 of 3
the plant species they claim, not be able to easily identify the source of the ingredients, or have failed to put
proper controls in place or conduct proper testing or measurement to prevent contamination.
To assist NYAGs investigation, we request the following documents and information relating to your
company and, if applicable, its subsidiaries:
1. For each herbal dietary supplement your company or any of its subsidiaries sold in New York on or after
January 1, 2013, a spreadsheet or similar document providing:
a.
b.
c.
d.
e.
f.
g.
h.
i.

The name of the supplement, as listed on the label;


The brand name or brand names under which the supplement was sold;
The name and address of the facility that manufactured the finished supplement;
The name, relative concentration, country of origin, and, if applicable, extraction method used
for each ingredient, component, or filler in the supplement;
The name and address of the vendor that supplied each ingredient, component, or filler;
The number of units sold quarterly since January 1, 2013 in (i) New York; and (ii) nationally;
Quarterly revenue since January 1, 2013 from units sold in (i) New York; and (ii) nationally;
A description of the analytic testing used, if any, to confirm the content, quality, purity, or
chemical composition of any ingredient, component, or filler; and
A description of the analytic testing used, if any, to confirm the content, quality, purity, or
chemical composition of the finished supplement.

2. Copies of all labels used since January 1, 2013 for all supplements identified in response to Request 1.
3. Copies of all manufacturing, licensing, or sales contracts executed, or in effect, at any time since January
1, 2013 concerning the production or distribution of the supplements identified in response to Request 1.
4. Copies of all documents reflecting standards or procedures in place or followed at any time since
January 1, 2013 to verify the content of herbal dietary supplements, including but not limited to
measures applied broadly across supplement categories and those restricted to individual products.
5. A detailed description of measures your company or its subsidiaries undertook to ensure and control
quality across the supply chain for herbal dietary supplements, 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 your company or its subsidiaries conducted on finished products to
substantiate affirmative claims, such as gluten free or hypoallergenic.
7. Copies of all documents your company or its subsidiaries received from or sent to the U.S. Food and
Drug Administration on or after January 1, 2013 regarding the manufacture or content of any and all
herbal dietary supplements, including but not limited to all Form 483s and the responses thereto.
8. Copies of all Bioterrorism Registration documents prepared by your company or its subsidiaries.

615 ERIE BOULEVARD WEST, SUITE 100, SYRACUSE, NY 13204 PHONE (315) 448-4800 FAX (315) 448-4853 WWW.AG.NY.GOV

February 23, 2015


Page 3 of 3
9. Copies of all reports, complaints, or other documents reflecting adverse health consequences, including
but not limited to allergic reactions, following the use of any herbal dietary supplement your company or
its subsidiaries produced or sold since January 1, 2013.
Please direct the requested documents and information to my attention at the following address: NYS
Attorney Generals Office, Dulles State Office Building, 317 Washington Street, Watertown, New York 13601.
Kindly provide these documents on or before March 13, 2015.
This letter and the above requests relate to an ongoing, duly authorized, law enforcement investigation.
We therefore request that you take measures to preserve all email and other documents relating to the subjects
discussed in this letter, including but not limited to the specific requests for information and documents. The
foregoing shall not constitute a waiver of or limitation on the Attorney General's authority to issue subpoenas or
take further enforcement action pursuant to applicable law.
If you have any questions, you may contact Assistant Attorney General Deanna R. Nelson at 315-7852444. Thank you in advance for your cooperation.

Very truly yours,

MARTIN J. MACK
Executive Deputy Attorney General
In Charge of Regional Offices

615 ERIE BOULEVARD WEST, SUITE 100, SYRACUSE, NY 13204 PHONE (315) 448-4800 FAX (315) 448-4853 WWW.AG.NY.GOV