AG/FDA Blog

Part 110 Lives Another Day

Yesterday FDA withdrew its directive to remove and reserve the Current Good Manufacturing Practice (cGMP) for Human Food regulations found in 21 C.F.R. Part 110. This is not groundbreaking as the cGMP requirements in Part 110 were codified into Part… Read More
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Categories: FDA

FDA Announces FY 19 User Fee Rates for Third Party Certification Program

Yesterday, FDA announced in the Federal Register, the Agency’s 2019 user fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certif… Read More
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Jack Block: This and That August 2018

By former USDA Secretary John R. Block Good news – ethanol exports are up 33% so far this year.  By year’s end, we should exceed last year’s record of 1.38 billion gallons. Turn to hogs – we have raised hogs on my farm all my life.  I know… Read More
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EAFUS Inventory Replaced by “Substances Added to Food” Inventory

CFSAN/FDA’s Office of Food Additive Safety (OFAS) has replaced the original Everything Added to Food in the U. S. (EAFUS) inventory with an upgraded version – the Substances Added to Food inventory. This new inventory — which contains about… Read More
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Categories: FDA

FDA Nutrition Innovation Strategy

FDA has announced a public meeting, entitled “FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy,” (Strategy) to be held on July 26, 2018, from 8:30 a.m. until 5:30 p.m. EDT, at the Hilton Washington DC/Rockville Hotel, 1750 Rockvill… Read More
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Categories: FDA

Intentional Adulteration Mitigation Strategies – Initial Draft Guidance

The FDA Food Safety Modernization Act contained provisions aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply.  This was the first time tha… Read More
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Synthetic Flavors’ Safety Questioned – Strategy Needed to Address Consequence

Food manufacturers using the following seven (7) synthetic flavoring substances and adjuvants should take note that the safety of these ingredients is being challenged: Benzophenone (a/k/a diphenylketone), Ethyl acrylate, Eugenyl methyl ether (a/k/a… Read More
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FDA Finalizes Nutrition Facts Compliance Date Extension by 1.5 Years

On May 4, 2018, the FDA issued its final rule extending the compliance date for the updated nutrition information on the labels of most conventional foods and dietary supplements. The final rule is consistent with FDA’s October 2, 2017 proposed rul… Read More
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FDA Maintains Focus on Nutrition to Foster Human Health

In a speech, entitled “Reducing the Burden of Chronic Disease,” delivered on March 29th by FDA Commissioner Scott Gottlieb before the National Food Policy Conference in Washington, D.C., FDA kicked-off its Nutrition Innovation Strategy. … Read More
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FDA Denies Use of Claim for Vitamin D Reducing MS Risk

Last week, the FDA concluded that there is no credible evidence of a relationship between intake of vitamin D and a reduced risk of multiple sclerosis (MS). The petition, submitted on behalf of Bayer, requested use of the claim “Vitamin D may reduc… Read More
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