The agency has avoided the issue for years but on November 12, 2015 the FDA published a “Request for Information and Comments” on the use of the term “Natural” in the labeling of human food products. Note that the general term "food" includes dietary supplements. [...]
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 attended a meeting with FDA staff from the Denver District Office in November of 2014. The meeting was an annual update from FDA addressed to the members of the Rocky Mountain Regulatory Affairs Society. Since most of the members work with medical devices, the [...]
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 [...]
Sometimes FDA and other government agencies seem to be a bit behind the times but just last week FDA published the 19th warning letter to mention Facebook. Some of these letters from the past three years have also cited Twitter and Tumblr as sources of [...]
Recently the trade publication, Cosmetics Design, published two articles that caught my eye. One discussed FDA’s Import Alert on cosmetics labeled as anti-aging creams. The import alert is FDA’s guidance to their staff that inspect imported products. FDA lists the reason for the alert as, [...]
In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. I will discuss the guidances in detail below but will start with the parts that are particularly interesting: First, [...]
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 [...]
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 [...]
The trade magazine, Natural Products Insider (NPI), recently published a slide show entitled, “Formulating Successful Products in Six Steps”. While 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 [...]
The weather is changing as a new season begins and it’s time to review recent FDA activity in the cosmetic sector. In June 2013 FDA published a draft guidance revising the Good Manufacturing Practices for cosmetics. While these GMPs remain voluntary, FDA Agents will use [...]
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 [...]
It has been a while since we have sent any updates for our dietary supplement clients. The FDA has remained busy inspecting supplement companies and writing many, many warning letters. The regulations for dietary supplement Good Manufacturing Practices (GMPs) include a section on quality control [...]
FDA recently updated the web page, “Information for Cosmetic Importers.” This document uses a question and answer format and the update offers some clarification on the use of INCI (International Nomenclature Cosmetic Ingredient) names for cosmetic ingredients: Is INCI nomenclature acceptable for identifying botanical ingredients? [...]
Here’s hoping that the first month of 2013 has been a good one for you! Thanks to our many valued clients, the year is off to a good start for our team. Our goal is to help your company comply with applicable FDA regulations. Accordingly, [...]
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. [...]
It has been many months since we’ve posted anything on cosmetic regulations. This edition is to make you aware of recent FDA enforcement actions and some proposed legislation that you should be aware of. We have had discussions with many of our clients about ‘wrinkle [...]
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 [...]
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 [...]
As posted here previously, FDA has committed to greater inspection of imported products; particularly imported food and dietary supplements (supplements are regulated as a special class of foods). We frequently work with companies that wish to import products into the US and have developed the [...]
Late last summer while visiting the Alaska State Museum in Juneau, a postcard with a photo of a decorated canoe caught my eye. On the front it said, "Genuine Alaskan Native Art" and on the back was a blurb about the Federal Trade Commission (FTC) [...]
Just a quick note: On September 14th we posted about USDA's requirement for listing nutritional information for major cuts of meat in retail establishments. At that time the effective date was January 1, 2012 but last week USDA announced that they have push the effective [...]