Not every probiotic product requires a clinical trial. Many probiotic strains already have a body of published evidence, and regulatory frameworks for dietary supplements and foods do not always mandate […] Read More >>
Probiotic trials rarely fail for a single reason. More often, problems emerge from a series of early design decisions that were never fully aligned: the strain chosen doesn’t match the […] Read More >>
Artificial intelligence is no longer experimental in regulated industries. It is being used to monitor claims, scan clinical literature, validate labels, screen ingredient risks, predict quality trends, and surface early […] Read More >>
Probiotic trials are frequently underpowered—not because sponsors ignore statistics, but because they underestimate how different probiotics are from conventional nutraceuticals. Unlike single-molecule ingredients, probiotics are living systems. Their ef Read More >>
Probiotic trials don’t fail only because a strain “doesn’t work.” Many fail because the endpoint doesn’t match the claim, the population, or the biology of a living product—and the study […] Read More >>
On March 6, 2023, the Food and Drug Administration (FDA) launched a new directory of ingredients used in dietary supplements. The directory will be a “one-stop shop” for ingredient information […] Read More >>
On Thursday, November 17, 2022, the Center for Food Safety and Applied Nutrition issued seven warning letters to manufacturers of supplements marketed for the promotion of cardiovascular health. The dietary […] Read More >>
The FDA recently published responses to several new dietary ingredient notifications (NDIN) submitted for nicotinamide mononucleotide (most notably the November 8, 2022 response to Inner Mongolia Kingdomway Pharmaceutical Ltd. “Kingdomway”). […] Read More >>
Health Canada has announced December 14, 2022, as the new date for when the Canadian Food Inspection Agency’s (CFIA) updated food labelling regulations (which came into effect on December 14, […] Read More >>
Just months after announcing that new documentation would be required for supplements sold on their marketplace, Amazon has again updated their requirements, this time without an announcement. In this latest […] Read More >>
Are you concerned that the dietary products that you consume are safe and that the environment in which they are manufactured is up to a particular standard? Well, you should […] Read More >>
Dietary supplement marketers selling on Amazon are now being asked to provide testing results and other manufacturing information on their supplement products in order to remain on Amazon’s site for […] Read More >>
Put yourself in the shoes of the consumer for a minute…okay…ready? You walk into a health food store to purchase supplements that you recently learned about that you hope might […] Read More >>
On February 11, 2019, FDA Commissioner Dr. Scott Gottlieb announced that the regulatory framework for dietary supplements is expected to change. It has been determined that changes are necessary due […] Read More >>
Failing to conduct proper regulatory due diligence can be likened to failing to conduct a proper home inspection before purchasing a home. We have all heard of home buyers who […] Read More >>
The Food Safety Modernization Act (FSMA) reaches across the entire food industry, not just conventional foods. Stakeholders and consumers rarely think of dietary supplements as foods, even though they are […] Read More >>
    The definition of blood pressure and its associated guidelines have recently been updated in the United States. Previously, high blood pressure was defined by the threshold blood pressure […] Read More >>
Service(s) related to this article: Dietary Supplement Consulting, Food & Beverages Proposition 65 (Prop 65) in California is not new. Officially coming into effect in 1986 requiring that in the state […] Read More >>
  Service(s) related to this article:  Dietary Supplements Dietary supplement use is a growing sector with unique regulatory requirements. dicentra’s dietary supplement consulting can help get you on the road […] Read More >>
Companies marketing dietary supplements aim to make claims for their products in order to help successfully market their products/product lines. As such, claims being made for dietary supplements are a […] Read More >>