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 [...]
Update February 22, 2017: Many foreign manufactures of foods and dietary supplements are finding that their FDA Food Facility Registrations have been invalidated. These are companies that updated their registration between October and December 2016 as required but whose US Agent failed to confirm the [...]
On August 11, 2016 FDA published their long-awaited revised draft guidance on New Dietary Ingredient Notifications.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 [...]
Updated May 19, 2016: New Menu Labeling Guidance was published on May 5, 2016 so the enforcement date for the regulations is May 5, 2017. See the full post here: https://fdasimplified.com/blog/ Updated March 9, 2016: FDA announced that they will delay enforcement of menu labeling [...]
I recently participated in the FDA /Joint Institute for Food Safety and Applied Nutrition (JIFSAN http://jifsan.umd.edu/) Food and Nutrition webinar. The webinar covered topics including food labeling, infant formula, medical foods, color additives, partially hydrogenated oils and dietary supplements. Most of the presenters that talked [...]
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 [...]
On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes. Products [...]
FDA has been busy in the past few months, publishing several draft guidance documents and proposed rules for food safety—including a proposal that would ban partially hydrogenated oils in foods.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 [...]
On November 7, 2013 FDA published a ‘Request for Comments and for Scientific Data and Information’ regarding the use of partially hydrogenated oils in foods. The FDA has reviewed the scientific data and has determined that there is no longer scientific consensus on the safety [...]
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. [...]
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 [...]
In January we told you about some of FDA’s plans for 2011. The agenda listed 18 types of over the counter drug products that are the subject of proposed rulemaking or other agency review. Back in June FDA completed one agenda item, review of proposed [...]
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 [...]
The device industry in the US continues to wonder what will become of the 510(k) process. Senator John Kerry of Massachusetts has written a letter to FDA Commissioner Dr. Margaret Hamburg raising concerns that the medical device industry has over potential changes to the 510(k) [...]
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 [...]
Hello! Last week the Food and Drug Administration and the Federal Communications Commission issued a joint statement regarding their intent to proactively address issues that arise when medical devices send patient information to physicians wirelessly. Issues such as the reliability and privacy of the communication [...]
Hello! Trade newsletters are reporting that FDA Commissioner, Dr. Margaret Hamburg’s remarks at the Food and Drug Law Institute conference discussed her priority to respond to the increase in adulterated and misbranded imported food products. Many of our clients have noted the increased scrutiny of [...]
I wanted to share with you another interesting post by Kurt Karst at FDALawBlog.com. This one discusses a recent court ruling on patents that has implications for FDA regulated industries. The decision, in part, states “Whoever marks upon, or affixes to, or uses in advertising [...]
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 [...]