The Justice Department's Assistant Attorney General for the Civil Division has announced that in 2011, its Consumer Protection Branch recovered more than $913 million in criminal and civil fines, penalties, and restitution, with most recoveries coming from food safety cases and health care fraud. In addition, the Branch secured convictions of 37 defendants, obtained prison sentences totaling more than 125 years against 32 individuals, and recorded a 95 percent conviction rate in 2011.
On March 2, 2012, 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 issued its weekly Enforcement Report for February 29, 2012 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On March 1, 2012, 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The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled, "Limiting the Use of Certain Phthalates as Excepts in CDER-Regulated Products." This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research's (CDER) current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). In particular, the draft guidance recommends that the pharmaceutical industry avoid the use of these two specific phthalates as excipients in CDER-regulated drug and biologic products, including prescription and nonprescription productions. Although comments may be submitted on any guidance at any time, FDA states comments should be submitted by May 31, 2012 to ensure FDA consideration before the agency begins work on the final version of the guidance.
On February 29, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Office of Management and Budget has extended its review of a Food and Drug Administration proposed rule required by the Food Safety Modernization Act (FSMA) that would establish and publish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities, at risk of contamination and serious adverse health consequences or death.
The Office of Management and Budget has extended its review of a Food and Drug Administration proposed rule 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.
On February 28, 2012, 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 is announcing a public food labeling workshop that will be held on April 24 and 25, 2012 in Stillwater, Oklahoma. This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. The goal of this public workshop is to present information that will enable manufacturers and regulated industry to better comply with labeling requirements, especially in light of growing concerns about obesity and food allergens. Topics to be discussed at the workshop include: (1) mandatory label elements, (2) the Food Allergen Labeling and Consumer Protection Act of 2004, (3) nutrition labeling requirements, (4) health and nutrition claims, and (5) special labeling issues, such as exemptions. FDA encourages interested parties to register by April 10, 2012.