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FDA Issues Warning Letters Against Illegal Tobacco Marketing, Flavored Cigarette Sales
May 31, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration has announced that it issued 11 warning letters during the week of May 16-20 to online retailers for illegally marketing tobacco products with misleading or unsubstantiated claims or descriptors indicating that they can be used to reduce harm or the risk of tobacco-related disease. FDA cited the online retailers for a variety of illegal marketing claims that violate the Federal Food, Drug and Cosmetic Act, including use of terms such as: “Light”; “Low”; “Mild”; “Less toxic”; or “Safer.” In addition to these marketing violations, other cited violations included the illegal sale of flavored cigarettes.

EPA to Require Electronic TSCA "New Use" Change Requests
May 31, 2011 by Barbara Chaves|FDA and EPA

The Environmental Protection Agency has issued a direct final rule amending the procedures for requests for modification or revocation of Toxic Substances Control Act (TSCA) section 5 significant new use notification (SNUN) requirements by establishing electronic submission requirements. EPA had issued a final rule in January 2010 introducing electronic reporting requirements for TSCA section 5 submissions and supporting documents but inadvertently left out requirements for electronic submission of requests for modifications or revocations of SNUN requirements.

Revised FDA Import Alerts on May 26
May 27, 2011 by Elizabeth Parker|FDA and EPA

On May 26, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on May 25
May 26, 2011 by Elizabeth Parker|FDA and EPA

On May 25, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on May 24
May 25, 2011 by Elizabeth Parker|FDA and EPA

On May 24, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Seeks Comments on Food Facility Preventive Controls for FSMA
May 25, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration is seeking comments and information about preventive controls and other practices used by facilities to identify and address hazards associated with specific types of food and specific processes. The information FDA receives will inform its development of guidance required by the Food Safety Modernization Act (FSMA) on preventive controls for facilities that manufacture, process, pack, or hold human food or animal food/feed.

FDA Updates Seizure and Injunction Chapters in Regulatory Procedures Manual
May 24, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration announces that as of May 20, 2011, changes in the procedures for the streamlined seizure and injunction process have been incorporated into Chapters 6 and 10 of its Regulatory Procedures Manual. The Manual provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.

Revised FDA Import Alerts on May 20
May 23, 2011 by Elizabeth Parker|FDA and EPA

On May 20, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Voluntary Recall of Certain Supplements due to Packaging
May 23, 2011 by Kelly Sly|FDA and EPA

The Food and Drug Administration announces that Phoenix Import & Distribution LLC is issuing a voluntary recall for PENTREXYL FORTE NATURAL because the packaging is believed to be misleading, causing it to be confused with an antibiotic. The product is packaged in a green and white box, containing 30 red and white capsules. PENTREXYL FORTE NATURAL is a Dietary Supplement only and does not contain antibiotics. The product was sold through retail stores in Texas.

Revised FDA Import Alerts on May 19
May 20, 2011 by Elizabeth Parker|FDA and EPA

On May 19, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of: