Articles for “FDA and EPA”

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.

Revised FDA Import Alerts on May 27

May 31, 2011 by Elizabeth Parker|FDA and EPA

On May 27, 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 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:

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.

Topics:Notable CROSS rulings

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 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.

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 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:

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: