8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

______________________________________________________________________________

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):

March 31, 2015 (March 30, 2015)

GNC HOLDINGS, INC.

(Exact Name of Registrant as Specified in Charter)

Delaware (State of Incorporation) 001-35113 (Commission File Number) 20-8536244 (IRS Employer Identification No.)

300 Sixth Avenue

Pittsburgh, Pennsylvania 15222

(Address of principal executive offices, including zip code)

(412) 288-4600

(Registrant’s telephone number, including area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

[ ]Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

______________________________________________________________________________

Item 7.01. Regulation FD Disclosure.

On March 30, 2015, GNC Holdings, Inc. (“GNC” or the “Company”) announced that it has reached an agreement with the New York Attorney General (the “NYAG”) regarding certain GNC-brand products that were included in an investigation by the NYAG into herbal supplements sold in New York State. The agreement affirms that the relevant GNC products were in full compliance with the federal Food and Drug Administration “Current Good Manufacturing Practices” (“GMP”), acknowledges GNC’s full cooperation with the Attorney General’s inquiries and confirms that the NYAG has discontinued its investigation as to GNC.

In early 2015, the NYAG commenced an investigation into the authenticity, purity and related marketing claims associated with herbal supplements sold in New York State, including specific lots of GNC-brand Herbal Plus® products. GNC fully cooperated with the NYAG's investigation and removed the affected lots from its stores in New York State temporarily, pending the NYAG's review of responsive information provided by GNC regarding its standards and procedures for authenticating the content of the products in question.

In its response to the NYAG’s inquiry, and as highlighted in the agreement, GNC provided the results of rigorous tests conducted both internally and by independent third parties. These tests provided conclusive evidence that GNC’s products are safe, pure, properly labeled and in full compliance with all regulatory requirements. The testing also demonstrated that the Company’s products contain all herbal extracts listed on their respective labels. In addition, a former senior FDA GMP expert performed a comprehensive review of GNC’s manufacturing processes for the products at issue and found them to be in compliance with all applicable requirements. Accordingly, GNC has restored its full assortment of Herbal Plus® products to all GNC stores in New York State.

As part of its commitment to industry leadership, GNC will expand its testing processes deeper into its supply chain by leading ongoing industry efforts to integrate source material traceability standards including DNA barcoding where appropriate (prior to extraction processes) and enhance certain other aspects of its operations to provide consumers even greater confidence in its products.

Copies of GNC’s press release and of the Company’s agreement with the NYAG are furnished herewith as Exhibits 99.1 and 99.2, respectively.

Item 9.01.Financial Statements and Exhibits.

(d)Exhibits:

Exhibit NumberDescription

99.1 Press Release, dated March 30, 2015

99.2 Letter Agreement, dated March 27, 2015, between GNC and the NYAG

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

March 31, 2015	GNC HOLDINGS, INC.
	By:	/s/ James M. Sander
		James M. Sander
		Senior Vice President, Chief Legal Officer
		and Secretary

Exhibit Index

Exhibit Number	Description
99.1	Press Release, dated March 30, 2015
99.2	Letter Agreement, dated March 27, 2015, between GNC and the NYAG

EX-99.1

GNC Reaches Agreement with New York Attorney General

Agreement Affirms GNC Products Meet all FDA Rules

GNC Restores Full Assortment of Herbal Plus® Products to Stores in New York State

PITTSBURGH -- Mar. 30, 2015 -- GNC Holdings, Inc. (NYSE:GNC), a leading global specialty retailer of health and wellness products, today announced that it has reached an agreement with the New York Attorney General regarding the Company’s Herbal Plus® products. The agreement affirms that the relevant GNC products were in full compliance with the federal Food and Drug Administration “Current Good Manufacturing Practices” and acknowledges GNC’s full cooperation with the Attorney General’s inquiries.

In its response to the NYAG’s inquiry, and as highlighted in the agreement, GNC provided the results of rigorous tests conducted both internally and by independent third parties. These tests provided conclusive evidence that GNC’s products are safe, pure, properly labeled and in full compliance with all regulatory requirements. The testing also demonstrated that the Company’s products contain all herbal extracts listed on their respective labels. In addition, a former senior FDA GMP expert performed a comprehensive review of GNC’s manufacturing processes for the products at issue and found them to be in compliance with all applicable requirements. Accordingly, GNC has restored its full assortment of Herbal Plus® products to all GNC stores in New York State.

As part of its commitment to industry leadership, GNC will expand its testing processes deeper into its supply chain by leading ongoing industry efforts to integrate source material traceability standards including DNA barcoding where appropriate (prior to extraction processes) and enhance certain other aspects of its operations to provide consumers even greater confidence in its products. The Company believes that given its position as an industry leader, these measures, which would not have impacted availability of the products subject to this review, will result in the adoption of stricter minimum standards across the broader industry - a win for the industry, the Company and consumers.

“As our testing demonstrated, and this agreement affirms beyond any doubt, our products are not only safe and pure but are in full compliance with all regulatory requirements,” said Michael G. Archbold, Chief Executive Officer of GNC. “A robust testing regime, careful sourcing regimen and detailed manufacturing specifications have always been core elements to ensuring that we provide our customers with high quality products. Our customers trust and value our products, and we are steadfastly committed to maintaining that trust and confidence. As an industry leader we have always gone above and beyond the minimum requirements in pursuing quality for our consumers, and we will continue to lead the efforts for higher standards. This is good for consumers, good for the industry, and good for GNC.”

GNC has preserved the specific product lots of the five products that were the subject of this inquiry for use in defending the Company against the lawsuits that have been filed subsequent to the NYAG’s February 2 letter, despite the fact that there is no prohibition against the sale of such products. The Company believes these lawsuits are completely without merit and will defend itself aggressively. Identical products to those that have been preserved remain available for sale to consumers at GNC stores in New York State.

About GNC Holdings, Inc.

GNC Holdings, Inc., headquartered in Pittsburgh, PA, is a leading global specialty retailer of health and wellness products - including vitamins, minerals, and herbal supplement products, sports nutrition products and diet products - and trades on the New York Stock Exchange under the symbol "GNC."

The Company has a diversified, multi-channel business model and derives revenue from product sales through company-owned retail stores, domestic and international franchise activities, third party contract manufacturing, e-

commerce and corporate partnerships.  GNC's broad and deep product mix, which is focused on premium, value-added nutritional products, is sold under GNC proprietary brands, including Mega Men®, Ultra Mega®, Total LeanTM , Pro Performance®, Pro Performance® AMP, Beyond Raw®, GNC PuredgeTM , GNC GenetixHD®, Herbal Plus® and under nationally recognized third party brands.  As of December 31, 2014, GNC has more than 8,900 locations, of which more than 6,600 retail locations are in the United States (including 1,070 franchise and 2,269 Rite Aid franchise store-within-a-store locations) and franchise operations in more than 50 countries (including distribution centers where retail sales are made).

Contacts

Sard Verbinnen & Co.

Bryan Locke/Bob Rendine/Ellen Davis, 212-687-8080

blocke@sardverb.com

rrendine@sardverb.com

edavis@sardverb.com

EX-99.2

[State of New York Office of the Attorney General Letterhead]

State of New York

Office of the Attorney General

120 Broadway

New York, NY 10271

Eric T. Schneiderman	Executive Division
Attorney General

Michael G. Archbold, CEO

GNC Holdings, Inc.

300 Sixth Avenue

Pittsburgh, PA 15222

Re: GNC-Brand Herbal Supplements

Dear Mr. Archbold,

This letter memorializes an agreement between the New York State Office of the Attorney General (“NYAG”) and GNC Holdings, Inc. (“GNC”).

Background

In early 2015, NYAG commenced an investigation into the authenticity, purity, and related marketing claims associated with herbal supplements sold in New York State, pursuant to Executive Law § 63(12) and other state laws. This initiative initially focused on four large retailers, including GNC. NYAG commissioned a study (the “NYAG Study”) that utilized DNA barcoding to test specific lots of six GNC-brand herbal supplements, including Echinacea, Garlic, Gingko Biloba, Ginseng, Saw Palmetto, St. John’s Wort, or associated extracts (the “Tested Supplements”).

As NYAG detailed in a letter to you, dated February 2, 2015 (the “NYAG Letter”), the NYAG Study did not detect identifiable genetic material for the plants depicted on the relevant labels for most of the Tested Supplements, but detected DNA associated with other plants, including the presence of a potential allergen in one product. The NYAG Study, and the NYAG Letter that conveyed the results to you, were directed at the presence or absence of the DNA of particular plant species in specified lots of GNC-brand herbal supplements, and did not reach a final determination that the Tested Supplements were fraudulent; the NYAG Letter raised concerns about the measures in place at manufacturers and retailers to ensure the authenticity and purity of herbal supplements.

120 Broadway, New York, NY 10271 · Phone (212) 416-6303 · Fax (212) 416-8942 · www.AG.NY.gov

GNC fully cooperated with NYAG’s investigation and removed the affected lots from its stores in New York State. GNC has represented to the NYAG that these lots will be held and are being preserved as proof in connection with consumer lawsuits that arose subsequent to the announcement of our investigation.

NYAG found no evidence in the course of its investigation that GNC deviated from the federal Food and Drug Administration (“FDA”) “Current Good Manufacturing Practices” (“cGMPs”) rules or standard industry practice in the production of the Tested Supplements. GNC also provided documentation of the scientific testing protocols and quality control methods that GNC employed on the Tested Supplements during production and as finished goods and of subsequent retesting by GNC and an independent laboratory. The results of this testing likewise indicate that the Tested Supplements were manufactured consistent with FDA cGMP requirements.

Where NYAG and GNC disagree, however, is on the sufficiency of federal rules and testing requirements and their relationship to state consumer protections laws. The FDA does not mandate the use of DNA-based technologies, like barcoding, to authenticate herbal supplements. Instead, the FDA allows companies to support their claims through other methodologies, including chemical analysis methods, like those employed by GNC. Given the existence of chemically-similar natural or synthetic substitutes, NYAG is concerned that standard chemical approaches provide inadequate assurance of the authenticity of herbal supplements. With respect to purity, FDA cGMP regulations allow for low levels of inadvertent contamination, including from allergens. NYAG is concerned, however, that there is no federal testing of products manufactured in cGMP facilities to confirm that contamination falls below relevant safety thresholds.

NYAG and GNC agree, however, that DNA barcoding holds great promise for further authentication. GNC has expressed its commitment to use DNA barcoding in its own supply chain, enhance other aspects of its operations, and lead the industry to adopt the same standards.

GNC Assurances

As soon as practicable, but no later than 18 months from the signing of this agreement, GNC will implement source material traceability standards that utilize DNA Barcoding¹to confirm the authenticity of the “active” herbal/ botanical ingredients² prior to extraction, if any, for all GNC Herbal Plus brand products,³except in circumstances where no DNA Barcode is available for the relevant species. GNC will implement source material traceability standards utilizing DNA Barcoding for any active herbal/botanical raw material ingredient used in the GNC Herbal Plus brand products as soon as a DNA Barcode becomes available.

¹ As used in this agreement, the term “DNA Barcode” means a reference sequence of DNA associated with a unique species of plant. “DNA Barcoding” refers to a technique for authenticating organic materials using DNA Barcodes.

² As used in this agreement, the “active” herbal/botanical raw material ingredient refers to the plant part or extract identified as coming from the plant listed in the active ingredients on the product label.

³ As used in this agreement only, the term “GNC Herbal Plus brand products” refers to the GNC Herbal Plus product line, and in addition, other GNC branded dietary supplements that have an herb in the product name.

2 of 6

GNC agrees to contribute any DNA Barcodes, and the scientific methods GNC used to identify such DNA Barcodes, to a publicly accessible database (the “DNA Barcode Library”) within the next 24 months for all the active herbal or botanical ingredients used in preparing GNC Herbal Plus products, where those DNA Barcodes are unavailable (either through a public domain source or through a license with a third-party vendor) and do not become available from another source within the 24-month time period.

Within 18 months, GNC will require that all “active” herbal/botanical ingredients used in the GNC Herbal Plus brand product line manufactured and sold in the US be manufactured in cGMP compliant facilities that are certified through a third-party accreditation body, such as ISO, USP, or NSF.

GNC will require that its suppliers implement a randomized allergen testing protocol on all “active” herbal/botanical raw material ingredients used in the GNC Herbal Plus brand product line using a recognized, robust industrial sampling technique (e.g., the square root plus 1 randomized testing protocol) to identify samples for testing. The allergen testing will employ the Polymerase Chain Reaction-Enzyme-Linked Immunosorbent Assay (PCR-ELISA) to detect the eight (8) most common allergens, as defined by FDA.

Using a recognized, robust industrial sampling technique (e.g., the square root plus 1 randomized testing protocol) to identify samples for testing, GNC will test finished products from the GNC Herbal Plus brand product line on an annual basis using a scientifically-validated technique, for the eight (8) most common allergens and to confirm any affirmative representations on the bottle label as to the absence of certain ingredients (e.g., “No sugar”).

GNC will prominently display customer-facing signage in all GNC retail locations that explains the difference between whole herbs and extracts using the wording in footnote 4.⁴

GNC will make available a template of this signage to any other retailer that sells GNC Herbal Plus brand products.

All product pages on the GNC consumer website for GNC Herbal Plus brand products that are listed as extracts will include in the product description section prominent links to the explanation of the differences between whole herbs and extracts using the wording in footnote 4, and a description of GNC’s extraction methods.

GNC will list all ingredients, including all excipients, on all GNC Herbal Plus brand product labels, per existing FDA rules.

On a semi-annual basis and at the conclusion of the term of this agreement, GNC will furnish a report to NYAG providing: (1) the number and species names of active herbal/botanical raw material ingredients used in the GNC Herbal Plus brand product line sourced after authentication using DNA Barcoding; (2) the name and address of all facilities in which DNA Barcode authentication was performed; (3) a list of materials rejected as a consequence of the results of DNA Barcoding and (4) the results of the randomized testing for the eight most common allergens.

⁴ Whole herbs are usually dried, chopped or ground into powder, and may be processed with water or alcohol for encapsulation. Standardized herbal extracts are made by dissolving herbs in a solvent like water, alcohol or liquid carbon dioxide, resulting in a chemical extract. The goal of standardization is to provide uniformity of a specific, constituent that may be biologically active.

3 of 6

GNC will, upon request by NYAG, provide all additional documentation and information necessary for NYAG to verify compliance with this agreement without the necessity for a subpoena.

NYAG Assurance of Discontinuance

This agreement constitutes an assurance of discontinuance for purposes of Executive Law § 63(15) that will discontinue NYAG’s investigation of GNC Herbal Plus brand products for authenticity, purity, and related labeling issues. NYAG reserves the right to bring an action against GNC related to any other subject. The agreement will be in effect for 36 months, will apply to GNC Herbal Plus brand products sold anywhere in the United States, and shall create no rights of enforcement for any third party, nor be deemed or construed to be an admission of liability by GNC or a waiver of any defense which GNC may have with any other party or entity.

Additional Provisions

Nothing in this agreement shall be construed to preclude GNC from complying with any Federal legal or regulatory requirement or applicable state law (“Applicable Law”), to which GNC is, or in the future will be, subject. Any Applicable Law which conflicts with any provision of this agreement shall supersede the provision with which it conflicts, but only if the conflict is such that compliance with the Applicable Law is impossible without modification of a provision of this agreement. However, in the event GNC interprets a new Applicable Law as in conflict with the provisions of this agreement, GNC shall provide reasonable notice to NYAG in writing. In the event that scientific or technological developments identify alternative methodologies to accomplish the purposes of this agreement, GNC may propose modification of the procedures herein for consideration by the NYAG.

NYAG has agreed to the terms of this agreement based upon, among other things, the representations GNC and its counsel made to NYAG, NYAG’s own investigation, and the documentation furnished by GNC. To the extent that any material representations are later found to be inaccurate or misleading, this agreement is voidable by NYAG in NYAG’s sole discretion.

In the event that any one or more of the provisions in this agreement shall for any reason be held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality, or unenforceability shall not affect any other provision of this agreement.

This agreement constitutes the entire agreement between NYAG and GNC, and it supersedes all prior agreements and understandings, written or oral, among the Parties with respect to the subject matter of this agreement. No representation, inducement, promise, understanding, condition, or warranty not set forth in this agreement has been made to or relied upon by any party in agreeing to this agreement.

No party shall take any action or make any statement denying, directly or indirectly, the propriety of this agreement. Nothing herein shall limit GNC, its agents or employees from testifying or asserting any defense in connection with any claims, investigations or litigation arising out of the subject matter of this agreement.

4 of 6

This agreement may not be amended, except by an instrument in writing signed on behalf of all of the parties to this agreement. This agreement may be executed in one or more counterparts, and shall become effective when such counterparts have been signed by each of the parties and exchanged electronically or in hard copy.

This agreement shall be binding on and inure to the benefit of all the parties hereto and their respective successors and assigns, provided that no party other than NYAG may assign, delegate, or otherwise transfer any of its rights or obligations under this Assurance without the prior written consent of NYAG.

Acceptance of this agreement by NYAG shall not be deemed approval by NYAG of any of the practices or procedures referenced in NYAG’s findings herein, and GNC shall make no representation to the contrary. GNC’s report, as described above, and any other notice in connection with this agreement, will be provided to:

The Office of the New York State Attorney General

Attention: Simon G. Brandler

120 Broadway, 25^th floor

Simon.Brandler@ag.ny.gov

Any communication between us regarding this matter will be addressed to:

GNC

Attention: Jim Sander

300 Sixth Avenue

Pittsburgh, PA 15222

Jim-Sander@gnc-hq.com

With a copy to:

Stuart Shorenstein, Esq.

Cozen O’Connor

277 Park Avenue

New York, NY 10072

sshorenstein@cozen.com

The recipients designated above may be changed by the relevant party by letter or email notice.

NYAG acknowledges GNC’s cooperation through this investigation and hopes that GNC’s commitments will lead to similar efforts throughout the industry and further broad reform.

5 of 6

Kindly indicate your agreement to the foregoing by signing a copy of this letter agreement and returning the same to me.

Very truly yours,

Eric T. Schneiderman

Attorney General of the State of New York

By /s/ Simon Brandler    

Simon G. Brandler

Senior Advisor & Special Counsel

Executive Division

Agreed to and accepted by:

GNC

By /s/ Michael Archbold    

Michael G. Arcbold

Chief Executive Officer

6 of 6