Articles by Marc Ullman
Managing An FDA Inspection: Making The Most of Your Chance to Put Things on Track From The Get-go
A primer for dietary supplement manufacturers, own brand distributors and ingredient suppliers. While the truism “You never get a second chance to make a first impression” has been attributed to both Will Rogers and Oscar Wilde, it is rarely disputed that that an initial encounter sets the tone for all future interactions and that it ...
FDA’s Misguided NDI Amnesty Scheme—But Companies Should Still Comply with the Law
On May 19, 2020, FDA (U.S. Food and Drug Administration) published a proposed Guidance Document announcing its intention to adopt a “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification: Guidance for Industry” (The Draft Guidance). This document announced FDA’s intent to consider, pending public comment, a six ...
Operating Your Business in the Time of COVID-19
As we move past the July 4 holiday into the “dog days of summer” with no signs of abatement in the rate of infection and hospitalizations caused by COVID-19, business owners are faced with a number of challenges maintaining effective operations. Some of these challenges (keeping your workforce safe) are new, some are old with ...
The ABH Nature’s Products Recall—Lessons for Own Label Distributors
On Jan. 21, 2020, ABH Nature’s Products, Inc., ABH Pharma, Inc., and Stocknutra.com, Inc. (collectively “ABH”) announced an unprecedented recall covering in excess of 1,200 products marketed by more than 800 different own label distributors (OLD—companies that hire a contract manufacturer to produce branded products for them). This action came as a result of an ...
FDA Enforcement 101
The U.S. Food and Drug Administration (FDA) has a broad mandate to protect the public health by ensuring that foods—including dietary supplements—(except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled. FDA also ensures that human and veterinary drugs, ...
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