This article was last updated on September 16 at 11 AM. The U.S. Food and Drug Administration (FDA) has issued a draft guidance document on its menu labeling rule. Draft Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11). […]
FDA Draft Guidance on Menu Labeling Read More »
By former USDA Secretary John R. Block We have a long agenda of actions that need to be taken and not much time to do the job. The federal government’s fiscal year ends this month. The Congress needs to approve the level of spending for next year. They aren’t going to get that done – not
John Block: This and That Read More »
The Food and Drug Administration (FDA) has released two major, final rules to implement the FDA Food Safety Modernization Act (FSMA). The final rules are: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; and Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals.
Products (e.g., food, dietary supplements, cosmetics) distributed in California are subject to Proposition 65, a voter initiative that became the Safe Drinking Water and Toxic Enforcement Act of 1986. Proposition 65 requires the State to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must
Proposition 65 Regulatory Changes Being Contemplated Read More »
In tomorrow’s Federal Register, FDA will publish a notice extending until October 13, 2015, the comment period on its proposed changes to the Nutrition Facts and Supplement Facts panels used in labeling conventional foods and dietary supplements. In connection with this comment period extension, the agency has placed additional documents in the docket, and will
FDA Extends Comment Period on Nutrition Labeling Reforms Read More »
Are you set up to succeed under the Food and Drug Administration’s (FDA) preventive controls final rules for human and animal food that have been sent to the Federal Register? Have you taken preliminary steps in your operation in advance of these rules becoming finalized? The FDA does not require you to take any advance
Doom and Gloom Challenges for Success Under FSMA Read More »
On Tuesday, the Environmental Protection Agency (EPA) announced that its Administrator signed the proposed rule: Management Standards for Hazardous Waste Pharmaceuticals Rule. The announcement and EPA blog post are here. The summary of the pre-publication proposed rule is available here and the 267-page proposal is available for download here. EPA is expected to publish the
By former USDA Secretary John R. Block There they go again. The EPA has threatened to impose a fine of $37,500 per day on farmer Andy Johnson of Fort Bridger, Wyoming. Mr. Johnson’s offense is that he built a pond for his horses and cattle on his eight-acre property. Before building it, he obtained a permit from
John Block: EPA Overreach Read More »
By Marshall Matz and Bill Imbergamo, as published in Agri-Pulse It’s another hot, dry summer, and another several million acres of public forests are going up in flames. As the end of August approaches, over 7 million acres have burned – including almost a million acres of National Forests, and those losses should concern all
National Forests on the Brink Read More »
By former USDA Secretary John R. Block Last week, I flew to Illinois – drove down to Springfield to attend Ag Day at the Illinois State Fair. Governor Bruce Rauner, State Senator Darin LaHood, and State Representative Don Moffitt led a crowd of 1,000 people in celebrating Illinois’ number one industry – Agriculture. The ceremony featured
John Block: Back to Illinois Read More »
OFW Law’s Bruce Silverglade will be a featured speaker at that Food and Drug Law Institute’s annual “Food Advertising and Litigation” conference on September 24, 2015, in Chicago, Illinois. Mr. Silverglade will participate in a panel discussing “Advertising and Labeling Trends and the Next ‘Natural.’” The conference takes place against a backdrop of approximately 200
By John R. Block “Got raw milk? Well, don’t drink it! …Too many people are risking their health and the health of their children unnecessarily.” Those are the words of Dr. Richard Raymond, former U.S. Department of Agriculture Under Secretary for food safety. His opinion piece in Feedstuffs Magazine sounds the alarm. Turn back the clock
John Block: Raw Milk Read More »
It’s August, which in Washington means Congress recesses, the President and much of the bureaucracy go on vacation and the wheels of government move more slowly than usual. However, that slower pace is going to be short-lived for the food industry. On or about August 30, just two weeks from now, FDA, under court ordered
It has been an interesting week from the perspective of an FDA drug promotion attorney. On the one hand, we have a federal district court expanding how drug companies can promote drugs; on the other, we have FDA’s Office of Prescription Drug Promotion (“OPDP”) issuing its first genuine Warning Letters in almost 10 months. Here,
FDA Drug Promotion Enforcement Update Read More »
In Part 1 of this blog series, I went back to Genetics 101 to provide a brief crash course on whole genome sequencing (WGS). Now that we better understand the technology, it is easier to understand how it can be utilized in the world of food safety. To begin with, the Food and Drug Administration (FDA), Food
Whole Genome Sequencing Part 2: Regulatory and Public Health Uses Read More »
In the last few years, we have seen the regulatory agencies begin to utilize a new detection method that will ultimately be a game changer – whole genome sequencing (WGS). Many of us may have heard of this technique related to cancer research and understanding inherited diseases. As the science has advanced, the complete DNA
Whole Genome Sequencing Part 1: What is It? Read More »
Officials at the Department of Health and Human Services (HHS) and the Department of Agriculture (USDA) have an opportunity to reiterate vital guidance on moderate drinking of alcoholic beverages with the coming new edition of Dietary Guidelines for Americans. USDA and HHS are putting the final touches on the new Guidelines, which are revised and
The Dietary Guidelines and Moderate Alcohol Consumption Read More »
The debate over agriculture biotechnology (aka genetic engineering (GE), genetic modification (GM), and GM organisms (GMOs)) was front and center in July. First, the White House issued an Executive Memorandum (“the Memorandum”) entitled “Modernizing the Regulatory System for Biotechnology Products.” The Memorandum, issued by the White House Office of Science and Technology Policy and Council
The Agriculture Biotechnology Riddle Read More »
Your product is ready. The formulation is finalized, packaging is designed, and your launch date is set. Then a labeling question surfaces — one involving 21 C.F.R. § 101.9 and a nutrient amount that falls in a gray zone between a rounding threshold and a compliance tolerance. Get it wrong, and you face potential misbranding
Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels Read More »
Paper medical device reports (MDR) will soon be a thing of the past. On August 14, 2015, the electronic MDR final rule goes into effect, requiring manufacturers, importers and other firms responsible for reporting to submit MDRs to the FDA electronically through the agency’s Electronic Submission Gateway (ESG) rather than through paper forms, including discs or facsimiles. As detailed in FDA’s February 13, 2014, final rule on Electronic Medical
Are You Ready for Electronic MDR Reporting? Read More »
In an unexpected move, FDA this coming Monday, July 27th, will publish a supplemental proposed rule that would establish a Daily Reference Value (DRV) for added sugars. This DRV would be utilized in calculating the percent Daily Value (%DV) that would be required to accompany the quantitative amount when Added Sugars is declared in nutrition
SURPRISE: FDA Proposes a Daily Value for Added Sugars Read More »
As President Obama signed Trade Promotion Authority into law, he removed a major stumbling block to completion of the Trans-Pacific Partnership (TPP) trade negotiation when chief negotiators, and then Ministers, meet in Maui July 24-31. However, a sticking point for many of the countries in the negotiation may be Canada’s reluctance to nix their protectionist
Inclusion in the TPP May Come at a Cost for Canada Read More »
On Thursday, the full U.S. House of Representatives will vote on H.R. 1599, which is officially titled “The Safe and Accurate Food Labeling Act of 2015.” The bill (full text here) would establish a federal standard for when foods containing genetically-engineered ingredients would be labeled as such and would preempt all state laws that pertained
House to Vote on GMO-Labeling Preemption Bill Tomorrow Read More »
On behalf of the Agriculture practice group at OFW Law, following is a copy of our Summer newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan at [email protected].
Regulatory Round-Up Newsletter, Summer 2015 Read More »
OFW Law founding principal Richard L. Frank fills in for former USDA Secretary John R. Block: Today’s Quiz: What has more alcohol – a 12 oz can of beer? A 5 oz glass of wine? Or, a mixed drink with 1.5 oz of spirits? Answer – they all have the same amount of alcohol. 0.6 fl oz. With
John Block Reports: Let’s Keep A Strong Alcohol Section in the 2015 Dietary Guidelines Read More »
Although HIPAA-compliant sponsored “refill reminders” have always been legally permissible for a host of treatments under California’s Confidentiality of Medical Information Act (CMIA), Cal. Civ. Code §§ 56-56.37, the state finally came right out and said so. California’s Office of Health Information Integrity (CalOHII), just published its long-awaited State Health Information Policy Manual (“Manual” or
The U.S. Department of Agriculture’s (USDA) Risk Management Agency (RMA) announced this week the availability of a new crop insurance coverage option that provides producers with coverage against an unexpected decrease in their operating margin. Starting in the 2016 crop year, the new Margin Protection plan will be available in addition to underlying crop insurance
USDA Announces New Operating Margin Protection Crop Insurance Option Read More »
On July 2nd, the White House issued an executive memorandum on “Modernizing the Regulatory System for Biotechnology Products.” The modernization effort will apply to “biotechnology products” defined as “products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes.” It will not affect regulation
FDA announced today it will give restaurants and “similar retail food establishments” an additional year – until December 1, 2016 — to comply with its menu labeling rule. The final rule originally required compliance by December 1, 2015. The FDA notice announcing the extension states that the agency received four requests for an extension citing
FDA Extends Compliance Date on Menu Labeling Read More »
Policy wonks could say that they have been thrilled these past two weeks. Congress spent a great deal of time dealing with specific issues related to nutrition standards, and finished with a historic joint committee hearing that focused on the interplay between the Supplemental Nutrition Assistance Program (SNAP) and other public assistance programs with the
Food Policy: Lots to Do with a Limited Number of Legislative Days Read More »
Two billion dollars – that is what FDA estimates the food industry will spend to comply with proposed changes to the iconic “Nutrition Facts” label. Part of that cost includes keeping records showing how much sugars companies add to processed foods and then disclosing that amount, per serving, on the food label. Will it be
Added Sugars Labeling Proposal Dropped by Health Canada Read More »
I am honored to be a new addition to the talented legal team here at OFW Law. Since joining the firm two weeks ago, I have been amazed at the breadth, depth and diversity of the talent here. Since the firm includes not only exceptional lawyers and policy advisors, but also scientists, doctors and other
Not Worried About the CPSC? Better Think Again! Read More »
By John G. Dillard and Jerry Chapin Do USDA’s mandatory supply controls violate the Fifth Amendment even if they are intended to prop up commodity prices? According to the Supreme Court, the answer is “yes.” On Monday June 22nd, all but one justice sided with California raisin growers and handlers, Marvin and Laura Horne in
The California Raisin Show: Last Gasp for the New Deal’s Supply Controls? Read More »
The Food Safety and Inspection Service (FSIS) has authority under the Federal Meat and Poultry Products Inspection Acts to ensure that products are not adulterated at retail and at all steps in the distribution chain. Retail operations are generally inspected by State or local authorities which have adopted some form of the model Food Code
Doom and Gloom: FSIS Provides Recommendations to Retailers on Listeria Control Read More »
