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 On Friday, July 1, 2011 FDA published the long-anticipated Draft Guidance for Industry on Dietary Supplement New Dietary Ingredient Notifications.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 [...]
In their settlement with Dannon over claims on DanActive and Activia, the FTC again evoked its standard of “two well-control clinical trials” to support structure function claims. This standard was previously applied to Nestlé’s Boost® Kids Essentials drink and POM Wonderful Pomegranate Juice (POM is [...]
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 [...]
The FDA has been busy lately, issuing many guidance documents and warning letters. Two that are of particular interest to the dietary supplement industry are a series of warning letters to companies marketing chelation/detoxification products and a new guidance on when FDA permission is required [...]
Once again I’d like to share information about FDA’s recent warning letters. This time, several of the letters discuss the agency’s objections to certain claims—claims, which many of our have been cautioned about when we reviewed their labels and labeling. The first involves the use [...]
Hello! I hope this brief update finds you well. Here in the US Summer’s heat is unrelenting and FDA is turning up the heat also. I learned today that FDA has issued letters to foreign food facilities that they will be inspected between October 1, [...]
The most amusing title I have ever seen on an FDA guidance document is “Is it a Cosmetic, a Drug or Both? (Or is it soap?)” http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm. This guidance addresses common misconceptions about how certain products are regulated. Hand sanitizers and antibacterial soaps are examples [...]
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 [...]
We thought that you would be interested in learning that the Safe Cosmetics Act of 2010 was introduced in the US House of Representatives this week. If passed and enacted this legislation would increase the regulation of cosmetic product in the US and would affect [...]