You’ve no doubt heard the news today that FDA is proposing a number of changes to the Nutrition Facts and Dietary Supplement Facts boxes that appear on US products. The proposed rules are based on review of the state of Americans’ health, dietary patterns and [...]
FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods. They also published updated guidance on cosmetic GMPs but have been relatively quiet about dietary [...]
The trade magazine, Products Insider Successful Products in Six Steps”. the presentation focuses on the development of dietary supplement products, similar considerations are helpful for cosmetic and food products as well. The steps were written for brand owners using contract manufacturers but also apply to [...]
Earlier this summer the US National Institutes of Health (NIH) launched the Dietary Supplement Label Database (DSLD). This website provides label information from supplement products marketed in the US. The database is easily searchable by ingredient, product name and company name and provides a summary [...]
If you are crunched for time during this end of year holiday season, this may be good news from FDA: In 2003 food and dietary supplement facilities were required to register with FDA. Re-registration or renewal was only required when information about the facility changed. [...]
Many of our dietary supplement clients have come to us for proactive assistance with proper labeling and other FDA regulatory issues. Unfortunately, some companies only found us after they had problems and were subject to enforcement action by FDA. It is expensive and time consuming [...]
Hello! Summer is in full swing here in the Northern Hemisphere and FDA is heating things up for the US dietary supplement industry. On Friday, July 1, 2011 FDA published the long-anticipated Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications. You can [...]
FDA warning letters continue to provide information that give insight into the level of detail of FDA inspection, which are relatively new to the dietary supplement industry and may help your company avoid problems when your inspection comes up. In a February 9, 2011 letter [...]
On March 3, 2011 FDA published a final rule that amended 21CFR 113, which regulates ‘thermally processed low-acid canned foods in hermetically sealed containers” to allow the use of ‘temperature indicator devices’ other than mercury filled glass thermometers. So why am I telling you about [...]
The information below was published in the Federal Register on December 20, 2010 but being that it is FDA’s published regulatory agenda, it is pertinent to any company regulated by FDA and provides a look at changes to anticipate. The Regulatory Flexibility Act of 1980 [...]
The FDA remains busy and last month I attended a conference that included a session on FDA enforcement and compliance for dietary supplements. The speakers included Jennifer Thomas, acting director, Office of Compliance, CFSAN, US FDA; Ralph Tyler, chief counsel, Office of Compliance, US FDA [...]
Hello! I trust that summer is flying by for those of you in the Northern Hemisphere and I hope that winter is not too harsh for those of you in the Southern Hemisphere. Since dietary supplement companies are now required to comply with FDA’s Good [...]
As 2009 draws to a close FDA continues their ramped up enforcement activities based upon new guidance documents and letters to industry. A draft guidance document published on December 7, 2009 lets us know that FDA is eyeing functional beverages and liquid dietary supplements for [...]
Hello! Many of our dietary supplement clients have struggled with complying with the Good Manufacturing Practice Regulations FDA wrote the industry. The following link takes you to an article in The Natural Products Insider that discusses the agency’s view and includes a video of Vasilios [...]