At FDA Compliance Simplified we enjoy working with companies of all sizes. Some of our clients are brand owners but not manufacturers. They team with contract manufacturers to produce shelf-ready products. This can sometimes make it hard to get the information we need to ensure [...]
The Food and Drug Administration (FDA) requires registration of manufacturing warehousing facilities for most product categories under the agency’s jurisdiction. This is true for food, dietary supplement, pet food, animal feed, drug, medical device, and biologic facilities. The only exception is the cosmetic sector; registration [...]
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 [...]
There is a bill before the Senate Committee on Health, Education, Labor, and Pensions that would drastically alter the path to market for new food ingredients. As an observer of FDA, I expect that this bill will have ramifications for the dietary supplement industry and the New Dietary Ingredient Notification process.
Many of you will recall that the 2016 updates to food nutrition labeling included a lower percent daily value for sodium (2300 mg/day). Along with that, the update proposed that there should be a gradual reduction in sodium levels. Last week FDA published a final [...]
Very few vegan protein products found in the U.S. market include corrected protein daily values in their nutrition or supplement facts boxes.
Few events are truly global but the 2020 pandemic has affected every living being on the planet in some way. It is the rare person whose life and/or business has not been turned upside down this year but I am pleased to bring you a [...]
FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
We are based in Colorado, a state that has legalized both medicinal and recreational marijuana use. Colorado's industrial hemp farming program was initiated through legislation adopted in 2013. On the national scene, passage of the 2018 Agriculture Improvement Act removed hemp from the controlled substance [...]
On December 21, 2018 USDA published their final rule on bioengineered food disclosure labeling, commonly known as “GMO labeling”. The rule adheres to the stipulations in the enabling legislation and is based on the current science but may not satisfy consumers.
The Food and Drug Administration (FDA) has historically worked in a reactionary manner. The original Pure Food and Drugs Act was passed by Congress on June 30, 1906 in response to studies that showed deleterious effects of food additives that were already in use in [...]
All food, pet food and dietary supplement facility registrations must be renewed between October 1st and December 31st of even-numbered years. 2018 is a renewal year and prior to the renewal period FDA published two guidance documents on facility registration (guidance and supplemental guidance). All [...]
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 [...]
2017 was a bit of a wild year with many twists and turns, stops and starts in the form of FDA actions. The agency once more delayed enforcement of restaurant menu labeling regulations; now set for May 7, 2018. The enforcement date for the revised [...]
Updated June 13, 2017: Today FDA announced that they will extend the compliance dates for the new nutrition facts labels but they have not announced what the new dates will be. Here is the information published on the FDA website: "FDA Intends to Extend Compliance [...]
The agency has avoided the issue for years but on November 12, 2015 the FDA published a “Request for Information and Comments” on the use of the term “Natural” in the labeling of human food products Note that the general term "food" includes dietary supplements. [...]
Updated May 19, 2016: New Menu Labeling Guidance was published on May 5, 2016 so the enforcement date for the regulations is May 5, 2017. See the full post here: http://fdasimplified.com/blog/ Updated March 9, 2016: FDA announced that they will delay enforcement of menu labeling [...]
I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN http://jifsan.umd.edu/) Food and Nutrition webinar. The webinar covered topics including food labeling, infant formula, medical foods, color additives, partially hydrogenated oils and dietary supplements. Most of the presenters that talked [...]
In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages (http://tinyurl.com/m443cla) and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (http://tinyurl.com/nhwqz26). I will discuss the guidances in detail below but will start with the parts that are particularly [...]