FDA Looks To Hone Supplement GMP Compliance With Sharper Focus For Inspections
This article was originally published in The Tan Sheet
FDA's supplement programs office is increasing its outreach to work with other agencies, states, the industry, health care professionals and consumer groups to improve oversight of the industry. The agency also expects GMP inspections to improve with officials focused on certain product categories.
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ODS Director Steven Tave says violative manufacturing processes and products remain common not because FDA isn’t enforcing its regulations. “I applaud those who stand behind their products, but can you stand with the same conviction behind every product on the market?” he said at regulatory summit organized by trade groups.
Reports are common about ORA officials not being knowledgeable about the agency's supplement manufacturing and marketing regulations or familiar with the commodity of dietary supplements, but relying on drug or food product manufacturing regulations when they inspect supplement facilities.
The firm's violative label claims include Aloe Vera Gel "cures everything" and its branding mistakes include failing to list all ingredients for its Aloe Capsules and Original Whole Leaf Aloe Vera Capsules.