Category: FDA
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FDA Responds to Senators’ Energy Drink Concerns
In response to a series of letters from Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.), Food and Drug Administration (FDA) officials have confirmed that the agency is currently reviewing the safety of energy drinks containing caffeine and other ingredients that act as stimulants and may require regulatory action if evidence of a health risk is…
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FDA Issues Notice on Records Collected in User Fee System
The Food and Drug Administration (FDA) has issued a notice about a new system of records involving information collected from those required to submit user fees to the agency. The notice outlines the types of information collected relating to fees assessed under the Freedom of Information Act, Animal Drug User Fee Act, Animal Generic Drug…
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Senators Call for Meeting with FDA over 5-Hour Energy® Link to 13 Deaths
Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have reportedly called for a meeting with Food and Drug Administration (FDA) Commissioner Margaret Hamburg after reports surfaced that the agency has received adverse event reports indicating that the caffeinated energy supplement 5-Hour Energy® may have been linked to the deaths of 13 people in the past…
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GAO Urges FDA to Leverage Other Countries’ Oversight Resources
The Government Accountability Office (GAO) has issued a report recommending that the Food and Drug Administration (FDA) revise its approach when comparing foreign food safety systems with the U.S. system to better ensure the safety of imported food. Under the FDA Food Safety Modernization Act, FDA’s enhanced oversight of food imports includes express authority to…
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Senators Continue to Push FDA on Energy Drinks
U.S. Senators Richard Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) have for the third time this year challenged the Food and Drug Administration (FDA) “to take immediate action” to address public concerns about energy drinks. In their October 26, 2012, letter to FDA, the senators write that they are “extremely concerned by reports of five deaths…
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Environmental Group Contends FDA Documents Show Doubts re: Antimicrobial Drugs
Public Employees for Environmental Responsibility (PEER) has posted to its website documents relating to the use of antimicrobial drugs in livestock feed received from the Food and Drug Administration (FDA) under a Freedom of Information Act request. According to PEER, internal memos show that FDA is not, as the agency has claimed, working successfully with…
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Senator Urges FDA to Improve Seafood Fraud Enforcement
U.S. Senator Barbara Boxer (D-Calif.) has urged the Food and Drug Administration (FDA) to take action to address seafood fraud. In her October 15, 2012, letter, Boxer defines seafood fraud as “the mislabeling of one species of fish for another fish that is often cheaper and more readily available.” Boxer cites studies purportedly showing that the…
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FDA Food Facilities Registration System Is Unavailable
While foreign and domestic food facilities, including farms, must renew their registrations with the Food and Drug Administration (FDA) beginning October 1, 2012, under the Food Safety Modernization Act, the agency is not accepting registration renewals at this time. Facilities required to be registered under the law are asked to check FDA’s website to learn…