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Magic’s in the Makeup: FDA Modernizes Cosmetic Product Labeling Requirements

“Can’t be good for my health,” a song lyric from Gwen Stefani and No Doubt’s early 2000s single, “Magic’s in the Makeup,” comes to mind when we think of the Food and Drug Administration’s possible motives for recent...more

A Series for FDA-Regulated Food Industry - Part 1: How to Adopt a Culture of Safety

An old adage is that an “ounce of prevention is worth a pound of cure.” Perhaps no setting is a more appropriate example of this than a company whose business centers on food products regulated by the Federal Food and Drug...more

Amazon Issues New Requirements for Dietary Supplements Sold on Its Site – At Least One Will Be Problematic

In a move that some in the natural product space have been asking for, Amazon has begun the process of implementing new requirements for selling dietary supplements on its online platform....more

Be Careful to Not Beat Yourself in the Race To Market and Wind Up Excluding Your Own Ingredient From Being Allowed in Food or...

We are often approached by clients interested in conducting studies relating to an article that qualifies as a dietary substance or ingredient. Some of these clients are interested in studies intended to provide insight into...more

Required Revisions to Nutrition and Supplement Facts Labels are to be Fully Implemented by January 1, 2021

The Food and Drug Administration issued new regulations requiring changes to the nutrition and supplements facts labels of conventional food and dietary supplements, respectively, on May 27, 2016....more

FDA Issues Proposed Rule Seeking to Clarify Evidence Relevant to Its Intended Use Determinations of FDA-Regulated Products

On September 23, 2020, the U.S. Food and Drug Administration (FDA) published in the Federal Register a proposed rule titled, “Regulations Regarding ‘Intended Uses.’”...more

No Food for You: FDA Detention of Food

Maybe it’s a product that you’ve imported into the U.S. dozens of times. Maybe this is your first time importing this product or you’re working with a new business partner. Maybe you’re very familiar with the process, or...more

Another Piece to the CBD Puzzle? FDA Submits Report on CBD Sampling Study to Congress

On July 8th, the Food and Drug Administration (FDA) submitted a report to the House and Senate Committees on Appropriations detailing the results of a sampling study of the current cannabidiol (CBD) marketplace....more

With One Warning Letter, FDA Demonstrates Many of the Ways It Can Establish the Intended Use of a Product Labeled as a Dietary...

On March 31, 2020, the Food and Drug Administration issued a Warning Letter to a dietary supplement firm for making claims about its products that establish the products are unapproved new drugs, in violation of Federal Food,...more

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