Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.
Latest from Malcolm Spicer
Agency exercises enforcement discretion on requirement for products to be labeled as containing artificial colors or dyes when those aren’t native to foods or ingredients, including added colors made from natural sources.
“Dietary Supplement Regulatory Uniformity Act” would prohibit states from adding requirements and rules for supplement manufacturing and sales on top of FDA regulations.
Hawaii proposes age-restricted sales but, unlike similar bills also filed in Alaska, Massachusetts, Michigan and Washington legislatures, would require behind-the-counter storage to limit consumer access in stores.
C&D starts 2026 with expectations to boost sales of latest acquisition, Touchland scented hand sanitizer, after halting sales of Flawless hair removal/nail care and Waterpik showerhead products and selling Spinbrush power toothbrush brand as well vitafusion and L’il Critter gummy supplement lines.
“FDA’s proposed GRAS rule would move GRAS closer to the NDI model in at least one key respect, which is mandatory notification,” says attorney Ashish Talati. Proposed rule isn’t expected to require removal of ingredients available through self-GRAS processes.
Both companies announced that during special meetings on Jan. 29, their shareholders voted nearly unanimous support for Kimberly-Clark’s $48.7bn acquisition proposed in November at $3.50 per share plus 0.14625 share for each Kenvue share.