At FDA Compliance Simplified, we focus on Food and Drug Administration regulations that cover a wide variety of products used in and on the bodies of humans and animals. However, no product is regulated by only one governing authority. At the federal level, all products [...]
The FDA has proposed a new definition of healthy and related terms for the purpose of food labeling. The current definition became effective in 1994 and focuses on limited levels of total fat, saturated fat, cholesterol, and sodium to establish a food as “healthy”. Under [...]
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
Successful launch of a product requires more than a good marketing plan. It is also important to know whether your product is subject to special regulations from various government agencies. While the Federal Trade Commission, Consumer Product Safety Commission and even the Environmental Protection Agency [...]
On June 14, 2018 FDA published two guidance documents on dietary fiber. “Dietary fiber” was not defined per se prior to the publication of the revised nutrition labeling regulations of 2016. The 2016 definition for dietary fiber has two parts. First, it includes “non-digestible soluble [...]
Update September 29, 2017: FDA announced extension of the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule to January 1, 2020, for manufacturers with $10 million or more in annual sales. The new date for [...]