On June 22, 2011, the Food and Drug Administration announced that it is screening certain food and beverages imported from Taiwan for the presence of the plasticizer diethylhexyl-phthalate (DEHP) and other phthalates such as butylbenzylphthalate, di-n-butylphthalate, dioctyl phthalate, and di-isodecyl phthalate.
The Office of Management and Budget has approved the Environmental Protection Agency's prerule entitled: Testing of Bisphenol A (BPA).
On June 23, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:
On June 22, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:
The Food and Drug Administration is announcing the availability of a guidance for small business entities entitled “Topical Acne Drug Products for Over-the-Counter Human Use - Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective," which is intended to help small businesses understand and comply with the requirements of the final rule that adds benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter topical acne drug products and provides new labeling requirements applicable to all OTC topical acne products marketed under the monograph.
The Environmental Protection Agency is issuing a direct final rule to make a minor change to the Resource Conservation and Recovery Act (RCRA) hazardous waste manifest regulations that affects those entities that print the hazardous waste manifest form in accordance with EPA’s Federal printing specifications. Specifically, the rule will amend the current printing specification regulation to indicate that red ink, as well as other distinct colors, or other methods to distinguish the copy distribution notations from the rest of the printed form and data entries are permissible. The direct final rule is effective on August 22, 2011 without further notice unless EPA receives adverse comments by July 22, 2011, in which case EPA will publish a timely withdrawal of the rule.
The Food and Drug Administration has issued a final rule, effective September 22, 2012, which amends its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act.
On June 21, 2011, the Food and Drug Administration posted a revised version of the following Import Alert on the detention without physical examination of:
The Food and Drug Administration issued a proposed rule to amend the sterility test requirements for biological products, which is intended to provide manufacturers greater flexibility and to encourage use of the most appropriate and state-of-the-art test methods for assuring the safety of biological products. The more flexible requirements would also address the challenges of novel products that may be introduced to the market in the future and potentially enhance sterility testing of currently approved products, among other things. Comments are due by September 19, 2011.
The Environmental Protection Agency has announced the release of two new databases to make it easier to find data about chemicals. These databases, the Toxicity Forecaster database (ToxCastDB) and a database of chemical exposure studies (ExpoCastDB), can be used by scientists and the public to access chemical toxicity and exposure data.