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 [...]
FDA Compliance Simplified is privileged to help companies of all sizes and from all over the globe achieve compliance with FDA regulations. Many are referred to us by existing customers, some find us online, and other come to us through quality service providers that help [...]
Major Cosmetic Regulation Update March 27, 2023 - FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program FDA issued an update today stating that they are no longer accepting voluntary cosmetic establishment registration and that information in the VCRP will not be transferred [...]
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 [...]
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.
On Friday, May 20, 2022, FDA published a policy on enforcement discretion regarding New Dietary Ingredients (NDIs) in the form of a draft guidance. The Dietary Supplement Health Education Act of 1994 (DSHEA) amended the FD&C Act and set up the dietary supplement regulations [...]
Update February 17, 2022: Please use this link to view the UNPA webinar "In the BEginning"... Dietary Supplements Supply Chain Starts with Ag mentioned in the original post. The webinar opens with a general introduction and the presentations begin as indicated below. Good Agricultural and [...]
Very few vegan protein products found in the U.S. market include corrected protein daily values in their nutrition or supplement facts boxes.
The year 2020 started out ordinarily enough for the FDA Compliance Simplified team. We had projects related to foods, dietary supplements, over the counter drugs (OTC), pet foods, and medical devices. On March 2nd we received our first call regarding a project related to the new virus that was beginning to affect the United States.
Helping companies comply with FDA regulations is our specialty. But FDA is not the only regulatory body our clients need to be aware of. As our readers know, from time to time we invite other experts to provide other regulatory information essential to market success [...]
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.
New ingredients for use in foods, dietary supplements, and pet foods each have unique review and approval processes mandated by FDA.
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 [...]
Importing consumer products such as foods, pet foods, dietary supplements, cosmetics and over the counter drugs is very complicated. Not only must FDA regulations be met, so must those of Customs and Border Protection. This post focuses on Customs side of the issue and links to a post that focuses on the related FDA regulations.
New rules on bioengineered food labeling along with updates to food labeling and the farm bill to end 2018.
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 [...]
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 [...]
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 [...]