In May, Shareholder Susan Brienza co-authored and filed an important formal Comment to the FDA on behalf of our client Jarrow Formulas, Inc. This Comment objected to the Agency’s Revised Guidance on the handling of innovative Probiotic Supplements when they are New Dietary Ingredients (NDI’s). This topic is significant in the supplement industry because: 1) a growing number of consumers take Probiotics for digestive and immune system health; and 2) the FDA’s Guidance would require that each new strain of an already safe and well-established species (such as Lactobacillus, found in milk and yogurts) would require an expensive and burdensome “NDI Notification.”
Read this NutraIngredients article “Jarrow challenges FDA on probiotics” for more details about the Comment submitted on behalf of Jarrow Formulas.