On December 5, 2011, the Food and Drug Administration updated its question and answer document on lipstick and lead. Though the document does not describe what has been updated, it has ten FAQs on issues such as whether FDA has limits on lead in cosmetics and possible next steps for regulation. FDA states that although it does not believe that the lead content found in its recent lipstick analyses poses a safety concern, it is evaluating whether there may be a need to recommend an upper limit for lead in lipstick in order to further protect the health and welfare of consumers. The FAQ also lists numerous lipstick brands, shades, lots, and corresponding lead levels according to 2007 EPA testing.
The Food and Drug Administration announced that at its request, on December 6, 2011, U.S. Marshals seized raw materials imported by Infinity Marketing Group, Inc. containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics banned by FDA since 2004 for use in dietary supplements. The seizure took place in Rancho Dominguez, California. FDA states that it coordinated with U.S. Customs and Border Protection, Immigration and Customs Enforcement, and the Drug Enforcement Administration to identify and remove these potentially dangerous products, worth more than $70,000, from the marketplace.
On December 5, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration reports that the Device Registration and Listing Module (DRLM) of the electronic registration and listing system (FURLS) was unavailable from 4:00 PM EST on Friday, December 2, 2011 until 8:00 AM EST on Sunday, December 4, 2011 due to required maintenance.
The Food and Drug Administration reports that on December 1, 2011, U.S. Marshals seized at its request all dietary supplements by a Wisconsin maker for false claims made about their safety and effectiveness in treating diseases such as asthma, cardiovascular disease, cataracts, glaucoma and infections. The products are not FDA-approved as safe and effective for treating any diseases. According to the complaint, the company also failed to follow the current good manufacturing practice (cGMP) requirements for dietary supplements, as required by federal law.
On December 2, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On December 1, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On November 30, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration has submitted a proposed rule to the Office of Management and Budget that would establish regulations concerning the content of foreign supplier verification programs. The regulations would require that each importer have a foreign supplier verification program that is adequate to provide assurances that each foreign supplier produces food in compliance with: (1) processes and procedures that provide the same level of public health protection as those required under section 418 (concerning hazard analysis and risk-based preventative controls) or section 419 (concerning produce safety standards) of the Food Drug and Cosmetic (FD&C) Act; and (2) sections 402 (concerning adulteration) and 403(w) (concerning major food allergens) of the FD&C Act.
The Food and Drug Administration has updated its question and answer document on low levels of lead found in food products commonly consumed by children in order to add information on whether any recalls of juice or baby food were conducted due to excessive levels of lead. FDA states that it knows of one regarding pomegranate juice concentrate manufactured in 2009 because the product contained elevated levels of lead.