In an effort to assist premium dietary supplement manufacturers with upcoming FDA GMP compliance audits and supply chain transparency obligations, A.M. Todd Botanical Therapeutics (AMTBT) is consolidating a number of its key botanical extracts under one line in an effort to assist dietary supplement manufacturers with upcoming FDA GMP compliance audits. The newly created DEFINED™ brand of botanical extracts and dietary ingredients will initially include: Bilberry 25% DEFINED™, Black Cohosh 2.5% DEFINED™, Ginkgo 24/6 DEFINED™, and Panax Ginseng 5% DEFINED™. Central to the company’s branding message will be information contained in product specific SIDI (Standardized Information on Dietary Ingredients) dossiers.
After reviewing language in the FDA’s new GMP’s, and discussing with industry trade associations and manufacturers the impact compliance would likely have on supply chain management, Todd Norton, Chief Operations Officer for A.M. Todd Botanicals states, “We saw a legitimate opportunity to provide greater value to dietary supplement manufacturers with a brand offering that articulates and embodies the essential requirements of this new business environment. Compliance to GMP’s is fundamentally changing the obligations and nature of relationships between suppliers and manufacturers. The types of inquiries we have received of late are evidence of this fact.”
A primary purpose of the GMP’s is to improve traceability and transparency of every facet of a dietary supplements composition and journey through the manufacturing process. Better documentation is essential to achieving this mandate. Use of the SIDI format provides manufacturers with standards on relevant information needed on raw dietary ingredients in a voluntary, standardized system.
Andrew Shao, Ph.D., Vice President, Scientific and Regulatory Affairs for The Council for Responsible Nutrition, outlined the purpose of SIDI to industry with this comment, “In an effort to fill the void of ingredient supplier qualification, industry trade associations jointly developed the Standardized Information on Dietary Ingredients (SIDI™) protocol as a tool to assist with information exchange between ingredient suppliers and dietary supplement manufacturers.” Norton adds, “Once A.M. Todd was introduced to the SIDI protocol we didn’t hesitate in embracing it, and improving on it where appropriate.”
Norton continues, “In understanding what FDA will require from manufacturers in the GMP’s it made perfect sense to initially focus on ingredients of significance and relevance to them. It is not by coincidence that our first four SIDI dossiers target botanical extracts that are widely recognized in industry as being prone to economically motivated adulteration, or spiking – ingredients likely to be on an auditors radar screen. Traceability and transparency are going to be paramount for manufacturers in addressing product situations like these.”
On May 1, 2009, FDA held a public meeting on Economically Motivated Adulteration (EMA). The purpose of the meeting was to discuss ways in which the food, (including dietary supplements and animal food), drug, medical device and cosmetic industries, regulatory agencies, and other parties can better predict and prevent economically motivated adulteration. EMA is a major challenge for many industries and costs consumers countless millions in terms of dissatisfaction and potential safety risks associated with the substandard quality of products consumed. And, with dietary ingredient suppliers falling outside the scope of the new GMP’s, there is a perception by some that there is little need or reason to re-evaluate their patterns and practices.
Norton concludes by saying, “At the end of the day, whether statutorily obligated or not, we (suppliers) are all in this GMP environment together. We believe manufacturers will begin taking a greater interest in their supply chain beyond just price point and a weak C of A. They have to. There are a limited number of suppliers who are uniquely qualified to provide valuable assistance to the manufacturing sector in terms of compliance support. With the introduction of our DEFINED™ brand, anchored with SIDI documentation, we are taking a more visible profile in positioning ourselves as being part of this industry and manufacturer-supportive supplier group.”
About A. M. Todd Botanical Therapeutics, LLC
A. M. Todd Botanical Therapeutics (AMTBT) is a leading developer, manufacturer and supplier of quality botanical extracts, custom and proprietary blends, dietary supplements and new bioactive products used in dietary supplements and functional foods. The company’s manufacturing facility is GMP certified by NSF, ensuring the quality for which A.M. Todd is famous. AMTBT, headquartered in Logan, Utah is a subsidiary of A. M. Todd Group. For 140 years, the A. M. Todd name has symbolized resourcefulness, quality and authenticity.