The FDA Compliance Simplified team has the privilege of working with companies from all over the globe. So not surprisingly, our clients frequently have import-related questions. Unfortunately, some folks ask questions only after the product has been shipped and detained in customs. We pulled the [...]
Many Americans will be gathering around the table for a Thanksgiving Day feast on November 27th. Special family recipes will be pulled out; fresh produce, dairy, and meat or poultry will be carefully chosen; and particular brands of key ingredients will be sought out to [...]
Today, June 11, 2025, FDA released new materials regarding New Dietary Ingredient Notifications (NDINs). The agency published two videos and a PDF fact sheet on NDINs. No changes have been made to the process, but FDA has provided simple, helpful details regarding the information required [...]
Product Classification Matters I always chuckle when I read the title of FDA guidance, "Is it a Cosmetic, a drug, or both? (Or is it a Soap?)". However, the correct classification of a product is no laughing matter—it is essential to ensuring compliance with the [...]
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 [...]
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 [...]
November 8, 2023, FDA announced that the enforcement date for cosmetic facility registration and product listing will be delayed until July 1, 2024. The announcement stated that this was "to provide regulated industry additional time to comply with these requirements." However, the guidance document itself [...]
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 [...]
As noted in a previous post, there are a number of new regulations that cosmetic companies must comply with by December 29, 2023 as part of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The regulations that are effective at the end of 2023 [...]
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 [...]
A respected colleague, Marian Boardley, recently published a blog post that is important for anyone in the dietary supplement industry. I’d like to share some highlights with you. Ms. Boardley frequently evaluates FDA data on inspections and shares her insights. In her recent post she shared a table [...]
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.
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 [...]
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.
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 [...]