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 [...]
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 [...]
I know the name of this blog is FDA Update but my team provides USDA regulatory help from time to time and that agency has caught my attention today. My favorite blog, FDA Law Blog by Hyman Phelps & McNamara posted about the new USDA [...]
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 [...]
I hope that your business is doing well enough to allow you to relax a bit as summer starts. Knowing that your contract manufacturer complies with FDA’s current Good Manufacturing Practices (cGMPs) can reduce stress a bit. But how do you know that their cGMPs [...]
In August of last year, we sent our cosmetic and OTC drug clients a link to a Hyman, Phelps and McNamara Law Blog Post about a lawsuit against FDA that sought to force the agency to finalize the tentative final monograph on hand sanitizers that [...]
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) [...]
Well, March 23, 2011, the statutory deadline for FDA to publish proposed rules on how to implement the nutrition labeling provisions of the Health Care Reform Act, has come and gone with no rules. Nation’s Restaurant News reports that in a statement FDA said, ““We [...]
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 [...]
The folks at Pharmalot have written an article about the Johnson & Johnson consent decree. The article includes a link to the consent itself, which details the cGMP requirements FDA expects to see at the drug manufacturer's facility. The consent decree details the systems that need [...]
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 [...]
While the EU has banned the presence of bisphenol-A in baby bottles (effective today), the FDA has not taken such a step. There was a joint Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) expert meeting in November 2010 [...]
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 [...]
If you are tuned to news about regulatory issues you are likely aware of recent lawsuits being brought against companies for claims made on food products. In one instance a mom in California is suing Nutella® over claims that the product is part of a healthy [...]