In a Jan. 17, 2002 press release by the Florida Attorney General GNC agreed to "...offer refunds to settle allegations that it deceived consumers into buying outdated products." According to that release, the Florida Attorney General, Bob Butterworth, stated, "Our concern from the beginning was whether GNC customers were getting the fresh, full-potency products they were promised. This agreement establishes corporate policies to make sure they do."
In February 2003, GNC President Lou Mancini was directly notified by Esterin USA Owner Sidney Schwartz, "...Irwin Naturals, Inc. do not have access to the Esterin Process Alfalfa Saponin raw material... Irwin Naturals, Inc. have knowingly manufactured and distributed the aforesaid products in the USA in violation of United States Department of Agriculture, Federal Trade Commission and the Federal Drug Administration laws governing the manufacture, distribution and labeling of dietary supplements... We strongly recommend that your organization take immediate action to safeguard your consumer and withdraw this product from your store shelves." Neither Mancini nor GNC responded or removed the product from GNC's shelves.
"Imagine my shock," said Schwartz, "when I went into several GNC stores one year later in February 2004 and found Cholestaid not only still on GNC's shelves, but re-dated from its original 2002 expiration date to new 2006 expiration dating, while still stating it contains our patented Esterin raw material -- yet we have not sold Irwin Naturals or their manufacturer, General Research Laboratories, any raw material since the year 2000!"
According to IPSG spokesperson Richard Hohn, "Cholestaid is not like Vitamin C, for example. Because the patented Esterin raw material relies on 'saponins' to bind with cholesterol in the stomach, it is imperative that (i) the saponin yield remains potent, and (ii) the pill effectively and completely dissolves in the stomach at the right time or the product is useless. It is for these reasons Esterin USA refuses to guarantee an expiration date beyond two years following manufacturing -- which also degrades potency due to the high heat and compression required to form the pill. A six year expiration date in our industry is simply unheard of."
According to Hohn, during a Feb. 24, 2004 conference call between IPSG and Irwin Naturals' former Head of Purchasing, Mr. Terry Jackson (now employed with Robinson Pharma Inc, of Santa Ana, Calif.), Jackson admitted not only that both he and Irwin Naturals President, Klee Irwin, instructed General Research Laboratories to re-package and re-date Cholestaid which had been returned to Irwin, but that Jackson was not aware of any testing which had been done to ensure the product's potency or safety.
In a Feb. 25, 2004 letter to GNC Legal, Irwin Naturals President, Klee Irwin, also confirmed they extended expiration dates on returned products, alleging Irwin's "right" to do so following verification of potency, but has failed to produce any evidence whatsoever that such verification was performed -- and Mr. Jackson's statements one day earlier appear to support that no testing or verification was performed. Irwin also stated, "...we intend to continue selling our good stockpiles of Cholestaid to GNC as we have been."
An Irwin Naturals employee familiar with the circumstances surrounding the re-dated Cholestaid sold to GNC confirmed their lack of support for Irwin's behavior in this matter, but wished to remain anonymous for fear of losing their job.
FDA views cholesterol as a potential "life-threatening" illness, and as such, in 2000, issued new, stricter rules for dietary supplements which help to manage cholesterol.
"Given thousands of consumers honestly purchased Cholestaid, based on the clinically proven cholesterol benefits of Esterin," said Hohn, "clearly thousands have needlessly been placed at potential life-threatening risk by taking a product which does not conform to the Esterin raw material supplier's expiration dating guidelines. We are not surprised by the actions of Irwin Naturals or General Research, but for GNC, one of the nation's leading marketers of vitamins and food supplements, to not immediately remove Cholestaid from their shelves -- especially after the Florida Attorney General's findings as recent as just two years ago -- is unconscionable. One would think the last thing GNC would want are more legal troubles or a consumer class action lawsuit."
Esterin USA and IPSG strongly urge FDA, FTC, and the respective Attorney General's Offices in all states where GNC is selling Cholestaid to take immediate investigative action against GNC, Irwin Naturals and General Research Laboratories to protect consumers nationwide from further harm.