FDA has published a Federal Register Notice announcing a significant change in how it prospectively will handle public comments submitted on rulemakings and other docketed matters by individuals in their individual capacity. Since the adoption of the government-wide electronic portal system for submitting and posting comments, FDA generally has not posted public comments submitted by
FDA Dockets Transparency To Be Enhanced Read More »
Just when you thought FDA menu labeling requirements were final and had preempted state and local laws, New York City’s (NYC) Board of Health approved on September 9 a new sodium warning label. The new law requires “covered establishments” (including restaurants with 15 or more locations nationally, doing business under the same name and offering
New York City Does It Again, Requiring a High Sodium Warning Read More »
The U.S. Food and Drug Administration (FDA) today published a Federal Register Notice soliciting comments on its GRAS Notification (GRASN) Program. “GRAS” is an acronym for the phrase “generally recognized as safe.” Under sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food is a food additive, which is
FDA Notice Provides a “Backdoor” for Commenting on GRAS Notification Program Read More »
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 The U.S. Food and Drug Administration (FDA) has issued a draft guidance document on its menu labeling rule. Draft Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with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FDA Draft Guidance on Menu Labeling Read More »
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
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 »
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 »
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 »
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 »
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 »
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 »
Last month, legislation that would affect, among other things, FDA’s regulation of medical devices and the manufacturers of such devices took a considerable step forward when it was introduced and then unanimously approved by the House Energy and Commerce Committee by a vote of 51-0 on May 21. Known as the 21st Century Cures Act (“Act”),
Device Firms: What You Should Know About The 21st Century Cures Act Read More »
By John R. Block We can’t seem to silence or satisfy the loud scream of opposition to GE crops. The reason probably is that up until now we have ignored them. It’s time to stand up and set the record straight. GE food is safe and even beneficial according to 88% of scientists. We have conducted
John Block: GMOs Under Assault Read More »
Yesterday, FDA released a Draft Guidance for Industry on Compounding Animal Drugs from Bulk Drug Substances (Draft Guidance). The Federal Register notice accompanying the Draft Guidance can be found here. The agency also withdrew its previous Compliance Policy Guide (CPG) 608.400, Compounding of Drugs for Use in Animals. Though FDA has been actively implementing Title
FDA Releases Draft Guidance on Compounding Animal Drugs Read More »
By Robert A. Hahn The FDA’s food labeling regulations include some traps for the unwary. A few of those traps have to do with the net quantity of contents declaration. Here are a couple of points to keep in mind when declaring a food product’s net contents: When the net contents declaration is expressed in terms
Clearing Up Confusion: The Net Quantity of Contents Declaration on Food Labels Read More »
By Barbara J. Masters, D.V.M. One of the goals of the Food Safety and Inspection Service’s Strategic Plan is to “ensure that facilities implement safeguards and systems to protect food from contamination by people who might try to intentionally and maliciously harm consumers.” The Agency has a FY 2015 target of 90% of all establishments having a
Food Defense Plans Read More »
By Mason Weeda FDA’s Center for Devices and Radiological Health (“CDRH”) and Center Biologics Evaluation and Research (“CBER”) recently published a new draft guidance entitled “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States [(“OUS”)] (“Draft Guidance”) (available here). With this Draft Guidance, FDA aims to minimize the possibility for additional
FDA Provides Another Guidance Concerning FDA’s Use of Foreign Study Data Read More »
This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency’s position on a matter, but it does
Warning Letters Update Read More »
FDA has published a proposed rule that would amend and update its regulatory requirements governing registration of food facilities. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essentially directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S.
Food Facility Registration Rules To Be Updated by FDA Read More »
In earlier blogs, I have mentioned having horses and other animals while growing up on a small farm. Even now, to my husband’s dismay, I have never outgrown being “horse crazy.” But during all this time, I never remember being concerned about the animal feed I have purchased or used. I do qualify this statement
FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm” Read More »
On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring 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, Spring 2015 Read More »
The 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its report to the Secretaries of Agriculture and Health and Human Services last month and disbanded. It is now up to the USDA and HHS to take the DGAC’s conclusions and recommendations and issue a revised edition of the Dietary Guidelines for Americans. Interested persons may submit
2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy Read More »
By Marshall L. Matz, as published in Agri-Pulse The March edition of the National Geographic Magazine, in its cover story entitled “The War on Science,” notes that “there’s no evidence that GMO’s are harmful to human health.” A recent Pew poll found that 90% of all scientists believe GMO’s are safe but only 37% of the public
The Vilsapp: Secretary Vilsack’s High Tech Solution to Labeling Read More »
