Earlier this week, the U.S. Food and Drug Administration (FDA) announced the launch of Pet Event Tracking Network (PETNet), “a secure, web-based information exchange system that will allow FDA and Federal and State Agencies to share initial information about pet-food related incidents, such as illness associated with the consumption of pet food or pet food products.” The new system is intended to improve communication about the safety of pet food products across and within various levels of federal and state government.
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On July 21, 2011, United States Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) urged U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to take prompt action and finalize the proposed rule for gluten-free labeling. As we previously reported, the FDA has not defined “gluten-free” in over four years following the release of the proposed definition.
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Last month, the U.S. Food and Drug Administration (FDA) appointed a new deputy commissioner for global regulatory operations and policy, Deborah Autor. Autor, the former director of the Center for Drug Evaluation and Research (CDER) Office of Compliance, is urging Congress to increase the FDA’s authority over imported drugs and the power to mandate recalls of unsafe drug products.
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The IRS has updated its Business Consultant Audit Techniques Guide (“ATG”) to include an income section addressing issues that may arise during examinations. The new section discusses Income Assignment and Substance Over Form issues as well as related audit techniques.
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Last week, the comment period closed for the U.S. Food and Drug Administration’s (FDA) guidance document, “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.”
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-08-03 16:05:272026-01-07 14:39:37Congress Seeks to Clarify FDA’s Conflict of Interest Rules for Clinical Investigators
Senate Majority Whip Richard Durbin (D-Ill.) introduced legislation on July 29 that would require online retailers to collect the same sales tax as local stores, prompting deeply polarized reactions to the bill.
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-08-03 13:27:562014-11-10 18:17:06Main Street Fairness Act Draws Divided Reaction
On July 21, 2011, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced its proposal to establish a common or usual name for raw meat and poultry products that include added solutions that may not be visible to the consumer. The Agency proposes that the common or usual name for such products should include “an accurate description of the raw meat or poultry component, the percentage of added solution incorporated into the raw meat or poultry product, and the individual ingredients.” (For the full text of the proposal, click here.)
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Last week, the U.S. Food and Drug Administration (FDA) issued an official warning letter to CytoSport, Inc., the makers of the popular fortified sports drink, Muscle Milk, for mislabeling their product as “milk.” The FDA has regulatory authority to issue a warning letter, an official notice that one of the establishment’s products, practices, or processes has violated the Food, Drug, and Cosmetics Act (FDCA). CytoSport continues to defend the name Muscle Milk and is “proactively and openly addressing the FDA’s labeling concerns.”
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-08-02 15:32:282014-11-10 18:17:06FDA Issues Warning Letter to Makers of Muscle Milk for Mislabeling
On June 30, 2011, United States Senator Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act of 2011(the “Bill”). The Bill proposes to amend the Federal Food, Drug, and Cosmetic […]
On May 25, 2011, the Natural Resource Defense Council (NRDC), a coalition of health and consumer organizations, filed suit against the U.S. Food and Drug Administration (FDA) regarding its regulation […]
https://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svg00admin_fidjhttps://fidjlaw.com/wp-content/uploads/2007/02/FIDJ-Logo-Hero.svgadmin_fidj2011-08-02 06:57:582025-12-09 15:05:08FDA Sued Over Approval of Antibiotics in Animal Feed
FDA to Launch Online Pet Food Tracking System
Earlier this week, the U.S. Food and Drug Administration (FDA) announced the launch of Pet Event Tracking Network (PETNet), “a secure, web-based information exchange system that will allow FDA and Federal and State Agencies to share initial information about pet-food related incidents, such as illness associated with the consumption of pet food or pet food products.” The new system is intended to improve communication about the safety of pet food products across and within various levels of federal and state government.
FDA Responds to Requests to Finalize Rule for Gluten-Free Labeling
On July 21, 2011, United States Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) urged U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg to take prompt action and finalize the proposed rule for gluten-free labeling. As we previously reported, the FDA has not defined “gluten-free” in over four years following the release of the proposed definition.
New Head of Global Compliance Seeks Increase of FDA Authority over Drug Imports and Recalls
Last month, the U.S. Food and Drug Administration (FDA) appointed a new deputy commissioner for global regulatory operations and policy, Deborah Autor. Autor, the former director of the Center for Drug Evaluation and Research (CDER) Office of Compliance, is urging Congress to increase the FDA’s authority over imported drugs and the power to mandate recalls of unsafe drug products.
IRS Adds Income Section to Business Consultant Audit Techniques Guide
The IRS has updated its Business Consultant Audit Techniques Guide (“ATG”) to include an income section addressing issues that may arise during examinations. The new section discusses Income Assignment and Substance Over Form issues as well as related audit techniques.
Congress Seeks to Clarify FDA’s Conflict of Interest Rules for Clinical Investigators
Last week, the comment period closed for the U.S. Food and Drug Administration’s (FDA) guidance document, “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.”
Main Street Fairness Act Draws Divided Reaction
Senate Majority Whip Richard Durbin (D-Ill.) introduced legislation on July 29 that would require online retailers to collect the same sales tax as local stores, prompting deeply polarized reactions to the bill.
USDA Proposes Rule to Establish Common Name for Raw Meat or Poultry with Added Solutions
On July 21, 2011, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced its proposal to establish a common or usual name for raw meat and poultry products that include added solutions that may not be visible to the consumer. The Agency proposes that the common or usual name for such products should include “an accurate description of the raw meat or poultry component, the percentage of added solution incorporated into the raw meat or poultry product, and the individual ingredients.” (For the full text of the proposal, click here.)
FDA Issues Warning Letter to Makers of Muscle Milk for Mislabeling
Last week, the U.S. Food and Drug Administration (FDA) issued an official warning letter to CytoSport, Inc., the makers of the popular fortified sports drink, Muscle Milk, for mislabeling their product as “milk.” The FDA has regulatory authority to issue a warning letter, an official notice that one of the establishment’s products, practices, or processes has violated the Food, Drug, and Cosmetics Act (FDCA). CytoSport continues to defend the name Muscle Milk and is “proactively and openly addressing the FDA’s labeling concerns.”
Proposed Legislation for Dietary Supplement Labeling
On June 30, 2011, United States Senator Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act of 2011(the “Bill”). The Bill proposes to amend the Federal Food, Drug, and Cosmetic […]
FDA Sued Over Approval of Antibiotics in Animal Feed
On May 25, 2011, the Natural Resource Defense Council (NRDC), a coalition of health and consumer organizations, filed suit against the U.S. Food and Drug Administration (FDA) regarding its regulation […]