Happy New Year, readers! Yet another year has come and gone. I hope that 2015 was a good year for you, professionally and personally. As I look back on 2015, here are a few developments that caught my attention. In January, the House Energy and Commerce Committee released a long awaited discussion draft of the […]
2015 In Retrospect Read More »
President Obama signed into law this week the Microbead-Free Waters Act of 2015 (H.R. 1321), which amends the Federal Food, Drug and Cosmetics Act to prohibit the manufacture and introduction into interstate commerce of rinse-off cosmetics containing intentionally-added plastic microbeads. The small plastic particles, often found in face washes, soaps and toothpaste, have become a
In the Federal Register of November 12, 2015, FDA published a notice announcing the establishment of a docket to receive information and comments on the use of the term “natural” in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering. See our
Comment Period Extended on “Natural” Read More »
FDA has created within CFSAN the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition, Labeling and Dietary Supplements (ONLDS). Elevating the program’s position will raise the profile of dietary supplements within the agency, and will enhance the effectiveness of dietary supplement regulation
CFSAN Office Restructuring Read More »
On September 17, 2015, the federal Food and Drug Administration (“FDA”) released a major final rule to implement the Food Safety Modernization Act (“FSMA”): Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (the “Final Rule”), 80 Fed. Reg. 56170 (Sept. 17, 2015). Additional information on the FSMA and the
Happy Holidays from OFW Law’s Dr. Barbara Masters, D.V.M., and Jolyda Swaim, A.K.A Dr. Doom and Ms. Gloom. As 2016 approaches, it is time for many of you to start considering the need to comply with the mandatory training requirements for Qualified Individuals as part of the FDA Hazard Analysis, Risk-Based Preventive Controls regulation. Dr. Doom and Ms. Gloom
For over two decades, when assessing the propriety of a “natural”-type claim (e.g., “natural,” “all natural,” “100% natural,” “from nature,” “naturally grown,” or “naturally sourced”) made in food labeling, FDA has applied an informal definition set forth in the preamble to a final rule implementing the Nutrition Labeling and Education Act of 1990. See generally
As we detailed in an earlier blog post, the White House issued a July 2nd executive memorandum on “Modernizing the Regulatory System for Biotechnology Products.” The memo directs the relevant federal agencies – FDA, USDA, and EPA – to update the federal government’s Coordinated Framework for the Regulation of Biotechnology, which was created in 1986 and last
GMO Regulatory Reform: The Way Forward Read More »
The Food and Drug Administration (FDA) has released three more major final rules implementing the FDA Food Safety Modernization Act (FSMA). The final rules are: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule); Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule);
FDA’s Fortification Policy is set forth at 21 C.F.R. § 104.20. It essentially sets forth principles for the rational addition of nutrients to foods. It provides: [FDA] does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods
Clarification of FDA’s Fortification Policy Read More »
FDA today announced that it has filed a petition submitted by the Grocery Manufacturers Association (GMA) to amend the food additive regulations to provide for the safe use of partially hydrogenated oils (PHOs) in limited food applications. Readers may recall that FDA issued a declaratory order in June 2015 announcing its final determination that PHOs
Partially Hydrogenated Oils – GMA Petition to Allow Limited Uses Clears a Hurdle Read More »
All ready-to-eat processors, whether regulated by the Food Safety and Inspection Service (FSIS) or the Food and Drug Administration (FDA), will have the environment, food contact surfaces, and products sampled for Listeria monocytogenes. While many facilities dread this, there is no secret to being prepared for a regulatory sampling. Establishments should expect that the regulatory
Doom and Gloom: “Check the Room” Read More »
Previous blogs have addressed Whole Genome Sequencing (WGS), what it is and its regulatory and public health uses. With use of WGS expanding at an amazing rate, an update is both appropriate and necessary. We recommend that everyone in the food industry keep an eye on this technology as it is now the method being
Whole Genome Sequencing Update Read More »
On behalf of the Agriculture practice group at OFW Law, following is a copy of our Fall 2015 newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan.
Regulatory Round-Up Newsletter, Fall 2015 Read More »
In a highly surprising and most unusual decision, FDA on Monday denied a broad-based industry request for an extension for 90 days of the comment periods relating to FDA’s supplemental proposal on “added sugars.” The proposal would establish a Daily Reference Value (DRV) for “added sugars” and require the Nutrition Facts panel to declare the
Sugar Labeling Proposal – FDA Not Too Sweet Read More »
By Marshall Matz and Jolyda O. Swaim, as published in Agri-Pulse We love our pets! There are approximately 80 million dogs in the United States and a similar number of cats. More than half of all American households share their home with at least one cat or dog. Evidence is conclusive that pets contribute to our well-being, both
Pets Are Us: Safety First Read More »
FDA has scheduled a public meeting in Chicago on Tuesday, October 20, 2015, from 8:30 a.m. until 5 p.m., (Central), as a follow-up to its recent publication of final rules establishing preventive controls requirements for human and animal foods. The public meeting will be broadcast as a live webinar, too. It is intended to provide
FDA Public Meeting/Webinar on FSMA Preventive Controls Final Rules (and Beyond) Read More »
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
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 »
