On March 22nd Mark Glazier traveled to Washington DC to meet with legislators and members of Congress to discuss the FDA's new NDI draft guidance among other issues important to the industry and consumers. The new NDI draft guidance as written can have actual repercussions in the supplements industry by removing safe and efficacious ingredients from the market. In addition to this new guidance, Mark also aimed to add multivitamins and other supplements containing essential micro and macronutrients to the WIC program.
The FDA's New Dietary Supplement Draft Guidance will limit ingredients available to be used in the industry by requiring companies to file NDIs for existing ingredients already allowed under DSHEA if the manufacturing process has changed since originally complying. Even though the ingredient is an exact same chemical structure, the new process will mean it has to have a new NDI filed. Since the cost of an NDI is between $350k and $500k, this will severely limit consumer choice and put a huge economic burden on companies to make these products compliant again.
Mark also met with Senator Robert Casey from Pennsylvania about the WIC program, a program implemented back in 1978 that provides low-income, at risk pregnant women, infants and children up to 5 with supplemental food to provide key nutrients likely to be deficient in their diets such as protein, vitamins A, C iron and calcium. His aim was to get supplements included in this program so that everyone can have access to necessary nutrients.
During Mark's stay, he was able to meet Senator Orin Hatch, who co-authored the DSHEA Act in 1994 which was the first major regulation of the industry. This Act defined dietary supplements and what had to be done to use a new dietary ingredient to ensure consumer safety. This act created regulation to stop the adulteration of products with pharmaceutical drugs. Lastly, it laid the foundation for GMP manufacturing regulations in the supplement industry. These regulations, 21 CFR Part 111, passed in 2008 all due to Senator Hatch.
This visit was just one battle in the war to regulate and ensure safety for consumers in the supplement industry, and we are committed to seeing this fight to the end. Only with leaders at the front of the charge like Mark Glazier can we hope to see the end of hidden ingredients, adulterated products, and non-transparent labels.