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20, 2022, FDA published a policy on enforcement discretion regarding New Dietary Ingredients (NDIs) in the form of a draft guidance.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 [...]
Very few vegan protein products found in the U.S. market include corrected protein daily values in their nutrition or supplement facts boxes.
Hindsight and 2020: A look back at FDA activities in 2019 and a look forward to 2020.
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 [...]
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 [...]
On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications. The guidance contains numerous requirements that will significantly affect the dietary supplement industry and establishes a 60 day comment period if manufacturers wish to affect the final rule. The [...]
Natural claims continue to be prominent on a variety of food and cosmetic product labels. As discussed in a previous post, FDA has not defined natural but requested public input on what the term should mean when used on food labels. The comment period closed [...]
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 [...]
The US Food and Drug Administration has responsibility to ensure the safety of consumer products through enforcement of regulations on many consumer products, including cosmetics. Cosmetics are subject to fewer regulations than are foods and drugs and it is not common to see FDA issue warning [...]
Last month I attended Supply Side West where my company, in conjunction with Nosco, Inc, presented information on packaging, labeling, and compliance. I spoke to a small group of attendees about how labels function as the table of contents to information about your product; information that [...]