Proposed legislation that would amend the drug preclusion provision in the Dietary Supplement Health Education Act of 1994 (DSHEA) has caused quite a buzz in dietary supplement industry groups. DSHEA is in need of at least a revamp since technological advances have rendered the thoughtful language [...]
On August 11, 2026, FDA published a proposed rule that would significantly change the process for introducing new food ingredients and products including them to the U.S. market. The current process requires that the substance be thoroughly evaluated for safety and is “Generally Recognized as [...]
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 [...]