XYMOGEN Responds to New York Times Article on the New York Attorney General Investigation

XYMOGEN Responds to New York Times Article on the New York Attorney General Investigation
XYMOGEN Responds to New York Times Article on the New York Attorney General Investigation

XYMOGEN Responds to New York Times Article on the New York Attorney General Investigation

  • by Admin
  • Wednesday, February 4, 2015

Dear Valued Customer,

I am writing you in response to the New York AG investigation of herbal supplements sold at retail outlets (GNC, Walgreens, Walmart, and Target).

While time will tell if the accusations against these companies are valid, I want to reassure you of the quality of XYMOGEN's Exclusive Professional Formulas. The facts are:

  1. As required by FDA GMP's, each and every raw material received into our facility is tested for identity. Identity testing is simply confirming that the raw material is indeed what it says it is on the raw material's labeling. Most identity testing is conducted via Fourier Transform Infrared Spectrometers (FTIR) or Thin Layer Chromatography (TLC).

  2. All FTIR identity testing is performed in-house, at XYMOGEN's state-of-the-art analytical laboratory. All TLC identity testing is performed by two of XYMOGEN's qualified third-party laboratories, Alkemist Labs and Advanced Botanical Consulting & Testing. These two companies are arguably the most reputable labs in the industry for the identification of botanical ingredients.
  3. In addition to finished product certificates of analyses (COAs), customers may also request COAs on raw material identity testing for any raw material in a given finished product lot.
  4. In assuring the purity, strength, and composition of all XYMOGEN formulas, each finished product has the following performed prior to releasing for distribution:
    • Label Claim Verification - Each active ingredient is verified to be no less than 100% of the amount claimed on the label.
    • Microorganisms - Must meet United States Pharmacopeia (USP), American Herbal Products Association (AHPA), and/or National Sanitation Foundation (NSF) acceptance criteria for dietary supplements.
    • Heavy Metals - Most products are required to meet USP acceptance criteria for dietary supplements. Where feasible, others must meet California's Proposition 65 safe harbor levels.
    • Physical Characteristics - Capsule/tablet weight average and weight variation, disintegration, organoleptic testing, scoop testing, etc.
    • Reasonably Anticipated Contaminants - In certain finished products, XYMOGEN will test for contaminants that have a slight possibility of ending up in the product. For example, due to the processing of pea protein and our assurance that all of our functional foods are gluten free, we test each and every lot for gluten to confirm it meets the FDA's recently finalized definition for "gluten free."

This level of testing IS NOT THE NORM in the nutraceutical field. The testing goes BEYOND FDA REQUIREMENTS. As mentioned above, customers are free to request a COA for any lot of finished product at any time. In addition to this, and in conjunction with XYMOGEN's ePedigree Track & Trace Program, we will be looking into ways to make these COAs even more accessible. The opportunity to view the actual test results provides an unprecedented level of documented quality assurance direct to your patients.

Thank you as always for your continued support and friendship.


Brian Blackburn

Tags: New York Times AG Investigation Herbal Supplements Label Claim Verification

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*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.