That did not take long. As we reported at the end of 2020, FDA announced in a notice the User Fees for OTC Monograph Drug Manufacturers and other fees. Then on Jan. 6, 2021, HHS announced that the fees are off the table. What happened? Well, …
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Riëtte van Laack
- OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the TableJanuary 11th, 2021
- HP&M’s Food, Beverage & Supplement Wrap Up: December 2020January 6th, 2021
Welcome to the final 2020 edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Happy New Year, everyone. Food & Beverage Make Every Bite Count: USDA and HHS …
- FDA Announces OTC Monograph Drug User Fees for Manufacturers for FY2021December 30th, 2020
As we previously reported, in March, as part of the CARES Act, OTC monograph reform was signed into law. This law amended the FDC Act to include, among other things, an OTC monograph drug user fee program, under which FDA is authorized to assess and …
- HP&M’s Food, Beverage & Supplement Wrap Up: November 2020December 7th, 2020
Welcome to the latest edition of Hyman, Phelps & McNamara, P.C.’s (“HP&M”) monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Tooting our own Horn: HP&M has been named the “Law Firm of the Year” …
- Petition to TTB Requesting Cancer Warning on Alcoholic BeveragesNovember 5th, 2020
The Alcoholic Beverage Labeling Act of 1988 (ABLA) directs the Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau (TTB) to notify Congress if science shows that the required warning statement on alcoholic beverages must be updated. Specifically, the ABLA provides that TTB “shall promptly …
- HP&M’s Food, Beverage & Supplement Wrap Up: October 2020November 4th, 2020
Welcome to the latest edition of HP&M’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. Food & Beverage Are your cows happy? Check out Karin’s blog post on corporate social responsibility claims. Is it a …
- FDA Wants to Know about Sugars That Do Not Act Like “Traditional Sugars”October 23rd, 2020
As we previously reported, FDA was petitioned to exempt allulose, a monosaccharide, from being included as a carbohydrate, sugar, and added sugar in the Nutrition Facts box, as well as recognize that the number of calories for this monosaccharide is less than the 4 calories …
- HPM’s Food, Beverage & Supplement Wrap Up: September 2020October 8th, 2020
Welcome to the inaugural edition of Hyman, Phelps & McNamara, P.C.’s monthly wrap up of food, beverage and supplement news, including regulations, guidances, events, and whatever else is catching our eye. (Yes, we know that beverages and dietary supplements are “food” within the meaning of …
- Citizen Petition Asks FDA to Enforce the FDC Act Requirement Regarding the Cumulative Effect of Food Substances as Part of Safety AssessmentOctober 6th, 2020
On Sept. 23, 2020, a coalition of public health and consumer advocacy groups submitted a Citizen Petition to FDA, requesting that FDA start considering the cumulative health effects of substances added to food as (according to Petitioners) is required by the Federal Food, Drug, and …
- Final Decision on Economic Analysis Report of Organic Livestock and Poultry Practices Rule and Summary of Comments on the Economic Analysis Report; The Lawsuit ContinuesSeptember 24th, 2020
Quite some time ago, we blogged on the organic livestock and poultry practice (OLPP) rule. The rule established minimum indoor and outdoor space requirements for chickens based on the type of production and stage of life, as well as added new provisions for livestock handling …
- Lawsuit Challenges USDA’s BE Labeling RuleAugust 24th, 2020
On July 27, 2020, the Natural Grocers, Citizens for GMO Labeling, Label GMOs, Rural Vermont, Good Earth Natural Foods, Puget Consumers Co-op, and the Center for Food Safety (“Plaintiffs”) filed a complaint against USDA challenging the final “BE labeling rule,” i.e., the final rule implementing …
- FSIS Petition: Don’t Rush Rulemaking for Labeling of Cell-based Meat and Poultry Products; Respect the First AmendmentAugust 17th, 2020
On July 23, FSIS acknowledged that it had received a Petition from the Harvard Law School’s Animal Law and Policy Clinic (Harvard or Petitioner) regarding the naming of cell-based or cultured meat and poultry products. Petitioner requests that the Food Safety Inspection Service (FSIS) of …
- GAO Report on Over-the-Counter DrugsAugust 10th, 2020
Under the Sunscreen Innovation Act (SIA), GAO was to review and report on FDA’s regulation of sunscreens and other over-the-counter (OTC) drugs. In late July, 2020, GAO issued its report on its performance audit conducted from July 2019 through July 2020. The report focuses on …
- FDA Finds Limited Evidence That Daily Consumption of Certain Cranberry Products Reduces The Risk of Recurrent UTIs in Healthy WomenJuly 28th, 2020
On July 21, 2020, the U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding consumption of certain cranberry products and a reduced risk of recurrent urinary tract …
- AMS Publishes Final Guidance related to BE LabelingJuly 20th, 2020
On July 8, the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) published in the Federal Register its notice on the issuance of final guidance to assist regulated entities in complying with the National Bioengineered (BE) Food Disclosure Standard (Standard). AMS previously …