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…
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…

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…
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…
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Intentional Adulteration Mitigation Strategies – Initial Draft Guidance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…

Isolated or Synthetic Non-Digestible Carbohydrates that Qualify as Dietary Fiber

FDA has published a guidance that specifies eight (8) additional substances that qualify as dietary fiber for purposes of nutrition labeling: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition…

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…

FDA Announces Medical Device Quality System Regulation Change

FDA recently announced a potential massive overhaul to its Medical Device regulations.  Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. Part 820) with an international consens…

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…

Menu Labeling – Supplemental Guidance

On the same day that FDA’s menu labeling regulation became effective for compliance by industry, the agency published notice of the availability of its finalized Menu Labeling: Supplemental Guidance for Industry (May, 2018). This guidance is “sup…

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.