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FDA Discusses Cosmetic Testing, Safety, Etc. With Canada, EU, Japan
July 11, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration reports that at the recent International Cooperation on Cosmetics Regulation (ICCR) fifth annual meeting in France, cosmetic regulatory authorities from Canada, the European Union, Japan, and the U.S. discussed issues related to cosmetics and cosmetic-like drug/quasi-drug products. The meeting focused on alternative test methods, nanotechnologies, safety assessment principles, trace contaminants, etc. There are plans to have a similar session at the sixth annual ICCR meeting to be held in the U.S. in 2012.

FDA/PDA Announce Joint Conference on Drug Compliance
July 11, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration and the Parenteral Drug Association have announced the 2011 PDA/FDA Joint Regulatory Conference & TRI Courses, entitled "Quality and Compliance in Today's Regulatory Enforcement Environment," that will take place on September 19-23, 2011 in Washington, DC. The theme of this conference was inspired by recent regulatory actions (483’s, Warning Letters, etc.) being issued to the global pharmaceutical industry. Registration is currently open. Note that different fees apply for registration before July 9, between July 9 - August 9, and after August 9.

Revised FDA Import Alerts on July 7
July 8, 2011 by Elizabeth Parker|FDA and EPA

On July 7, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on July 6
July 7, 2011 by Elizabeth Parker|FDA and EPA

On July 6, 2011, the Food and Drug Administration posted a revised version of the following Import Alerts on the detention without physical examination of:

FDA Discusses Recent Progress in Implementing FSMA
July 7, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration has added updated information on its progress in implementing the Food Safety Modernization Act. In May 2011, FDA issued interim final rules on prior notice of imported food and administrative detention and sought information on FSMA preventive controls. In June, it held a public meeting on FSMA inspections and compliance. On July 3, FDA issued both a joint anti-smuggling strategy for food with the Department of Homeland Security and a draft guidance for the dietary supplement industry. FDA also reminds the trade that on July 3, 2011, two new FDA authorities went into effect: the ability to suspend the registration of food facilities and the ability to more easily administratively detain food as established in the May interim final rule. Additional information on FDA's implementation progress is available here.

FDA Issues Draft Guidance on Dietary Supplements
July 5, 2011 by Karen Marzullo|FDA and EPA

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Dietary Supplements: New Dietary Ingredient Notifications and Related Issues." The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as "NDI notifications"). To be considered for the final version of this guidance, comments are due by October 3, 2011. Draft guidance available here.

Revised FDA Import Alert on July 1
July 5, 2011 by Elizabeth Parker|FDA and EPA

On July 1, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:

FDA Corrects Rule on OTC Sunscreen Drug Labeling
July 5, 2011 by Karen Marzullo|FDA and EPA

The Food and Drug Administration has issued a correction to its final rule, which effective June 18, 2012, will require over-the counter sunscreen products to comply with certain content and format requirements for OTC drug labeling. FDA is correcting a formula for calculating the erythema action spectrum weighting factor in 21 CFR 201.327(i)(1)(ii)(A)(2) and (3). (See ITT's Online Archives or 06/14/11 news, 11061447, for BP summary of the final rule.)

FDA Issues Steps to Request FD&C Act Tobacco Equivalence Exemption
July 5, 2011 by Elizabeth Parker|FDA and EPA

The Food and Drug Administration has issued a final rule, effective August 4, 2011, that establishes a procedure for requesting an exemption from the substantial equivalence requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act applicable to tobacco products. Among the procedures included in this final rule is the requirement that a request for an exemption and all information supporting the request be submitted in an electronic format. The final rule also addresses FDA’s review of an exemption request and establishes procedures for rescinding an exemption. The final rule states these requirements offer an additional channel for legally introducing new tobacco products that result from minor modifications of tobacco products that can be sold under the FD&C Act and that successfully introducing a product through this channel is expected to reduce costs.