On February 23, 2015, Nature’s Way received a letter which constituted “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.” The letter from the NYAG makes no allegations against Nature’s Way and provides no indications of any quality or compliance problem with any Nature’s Way product. The letter is simply a “request” for documents and information.
Nature’s Way products are produced in accordance with the federal Food and Drug Administration’s (FDA’s) Dietary Supplement Good Manufacturing Practices (GMPs), 21 CFR 111. Nature’s Way is audited by FDA to confirm compliance and continues to hold Dietary Supplement GMP Certification through NSF International, a GMP Certificate from the Australian Department of Health’s Therapeutic Goods Association (TGA) and is a licensed site for the production of Natural Health Products (NHPs) marketed in Canada. Nature’s Way intends to cooperate with the NYAG request for documents and information, as we are proud of our Quality Assurance processes and the steps that we take to both comply with the law and produce products of the highest quality.
For Immediate Release:
Schwabe North America’s Enzymatic Therapy Facility First in USA to Achieve Drug GMP Certification from UK’s Medicines and Healthcare Products Regulatory Agency
Schwabe North America’s Enzymatic Therapy® manufacturing facility has been awarded the Drug Good Manufacturing Practice (GMP) Certification by the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
GREEN BAY, WI (Nov. 24, 2009) — Wisconsin-based, Enzymatic Therapy, Inc. (ETI), a key brand of Schwabe North America, is the first US nutritional supplement company to receive the prestigious Drug Good Manufacturing Practice (GMP) certification from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The ETI manufacturing facility is also organically certified, a drug GMP audited establishment and has received the NSF GMP Certification by NSF International, the Public Health and Safety Company™. Adding the MHRA Drug GMP allows the facility to manufacture medicine for the European Community. Not only does this widen the scope of the market, it highlights the company’s serious commitment to safety and the highest quality manufacturing standards.
“Enzymatic Therapy has made the commitment to deliver exceptional quality, safety and purity in all the products we manufacture,” said Travis Borchardt, Vice President of Regulatory Affairs and Quality Assurance and Control. “The MHRA Drug GMP Certification reflects our ongoing mission to deliver superior products that people can trust.”
The MHRA is the UK government agency responsible for ensuring that medicines, herbal medicines, homeopathic remedies and medical devices work, and are acceptably safe. The UK has contributed, together with other Member States of the European Economic Community, requirements for the control of medicinal products. MHRA experts assess all applications to ensure they meet the required standards and follows up with a system of inspection, testing and safety monitoring.
“Adding the MHRA Drug Certification to our roster of quality manufacturing credentials confirms that our products meet strict requirements,” Borchardt explained. “Our Quality Assurance and Manufacturing Systems are recognized and respected by regulatory agencies at the local, state, federal and international levels.”
Find out more at www.enzymatictherapy.com or www.mhra.gov.uk.