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 [...]
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 [...]
Hello! Everyone who eats believes they know at least a little bit about food labels; some even think they understand them completely. But folks in the food business know that labels can be surprisingly complicated and sometimes even frustrating. In the past several months [...]
Hello! We have become aware of a new manual from the American Herbal Products Association (AHPA) that provides guidance as well as templates for preparing Standard Operating Procedures (SOPs) for compliance with Dietary Supplement Good Manufacturing Practices (GMPs). Having SOPs is an important part of [...]
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 [...]
The Federal Trade Commission in conjunction with the Food and Drug Administration has announced that they have issued warning letters to several companies who are making claims regarding omega 3 fatty acids and brain and vision function. The agencies are seeking information regarding the substantiation [...]
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 [...]