FDA has published a final rule (81 Fed. Reg. 54,959 (Aug. 17, 2016)), based on its 1997 proposed rule (62 Fed. Reg. 18,937 (Apr. 17, 1997); see also 75 Fed. Reg. 81,536 (Dec. 28, 2010) (reopening comment period)), which: Clarifies the criteria for when the use of a substance in a food for humans or […]
FDA Finalizes GRAS Rule Read More »
Today, the Food and Drug Administration (FDA) published in the Federal Register a final rule that amends relevant FDA regulations in Title 21 of the C.F.R. to change the address of the Center for Food Safety and Applied Nutrition (CFSAN). 81 Fed. Reg. 49894 (Jul. 29, 2016). CFSAN did not actually move its physical location
CFSAN Changes Address Read More »
Contributor: Rachel Rosenberg As of July 16, 2016, FDA’s amendment to expand the safe uses of vitamin D2 and D3 as nutrient supplements in food for human consumption became effective. This amendment stems from a food additive petition (FAP 3A4801) filed by Dean Foods Company and WhiteWave Foods Company. Vitamin D2 may now be used
FDA Amends Food Additive Regulations to Expand Permitted Uses of Vitamin D in Food Read More »
The agency on July 14, 2016 published FDA Foods and Veterinary Medicine Program (FVM) – Strategic Plan — Fiscal Years 2016–2025. This FVM Program outlines goals and objectives for the next 10 years: GOAL 1: Food Safety Hazards — Protect America’s Consumers and Animals from Foreseeable Hazards 1.1: Establish and gain high rates of
FDA’s Strategic Plan for Foods and Veterinary Medicine Read More »
Yesterday, Senate Agriculture Committee Chairman Pat Roberts (R-KS) and Ranking Member Debbie Stabenow (D-MI) released their long-awaited bill that would establish a federal GMO labeling regime and preempt any state laws, such as Vermont’s Act 120. This legislation, unlike earlier attempts, is expected to garner enough support to gain enough support to pass in the
Senate Ag Leaders Unveil Compromise GMO Labeling Bill Read More »
Last week, FDA’s Center for Devices and Radiological Health (CDRH) announced the availability of a Draft Guidance on “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” to clarify that “manufacturers may share patient-specific information recorded, stored, processed, retrieved, and/or derived from a medical device with the patient who is either treated or diagnosed with
The Food and Drug Administration (FDA) has published in the Federal Register a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration, 81 Fed. Reg. 34,165 (May 27, 2016), 21 C.F.R. Part 121 (Final Rule). The proposed rule was issued on December 24, 2013. The revisions in the Final Rule are largely designed
FDA yesterday released so-called “voluntary” targets for sodium reduction for 150 categories of foods. A spreadsheet issued by the agency details baseline sodium content for each of the categories and lists short-term and long-term targets. In its draft guidance, the agency says it “recognizes the important role of sodium in food for microbial safety, stability,
“Voluntary” FDA Sodium Targets May Bind Food Companies Read More »
FDA has finalized a new food safety rule under the Food Safety Modernization Act (FSMA) that is intended to help prevent wide-scale public health harm by requiring companies in the U.S. and abroad to take steps to prevent intentional adulteration of the food supply, including acts of terrorism targeting the food supply. While such insidious
Pursuant to consideration of public comments submitted on its October 2009 draft guidance document (see our prior article here), FDA today announced (81 Fed. Reg. 33,538) the availability of its finalized guidance document, Guidance for Industry: Ingredients Declared as Evaporated Cane Juice (May 2016). The guidance document essentially conveys FDA’s view that sweeteners derived from
FDA Nixes “Evaporated Cane Juice” as Ingredient Name Read More »
FDA has issued final regulations changing the requirements for the Nutrition Facts label required on almost all foods since 1994. A picture tells a thousand words, or in this case, more than 1000 pages of typewritten text detailing the new regulations that will appear in the Federal Register on May 27, 2016. The following is
FDA Issues Final Regulations for Nutrition Facts Labeling and Serving Size Changes Read More »
FDA has updated and published its Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition (05/12/2016). The guidance document is consistent with the agency’s good guidance practices regulation, 21 C.F.R. § 10.115. FDA published earlier versions of the guidance document in May 1997 and May 2007. This guidance is a second edition of
FDA Finalizes Guidance Document about Medical Foods Read More »
FDA has published a Level 1 guidance document, entitled “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).” 81 Fed. Reg. 27,067 (May 5, 2016). The guidance document is issued consistent with the agency’s good guidance practices regulation (21 C.F.R. § 10.115), and
Final Menu Labeling Guidance Issues: Setting Effective Date for Menu Labeling Final Rule Read More »
Earlier this week, the George Washington University Regulatory Studies Center released a significant report, “International Regulatory Cooperation: Benefits, Limitations, and Best Practices.” This report builds on earlier work done by the Center and examines opportunities to improve regulatory cooperation between the European Union and the United States. The report is timely because negotiators from the
EU-US Regulatory Cooperation: Strides Made, but More Can Be Done Read More »
FDA has issued a final rule on Sanitary Transportation of Human and Animal Food. The rule creates new requirements for shippers, loaders, carriers, and receivers of food transported by rail or motor vehicle in the United States. A fact sheet and other information about the final rule are available here and here. FDA will hold
Another FSMA Final Rule: Sanitary Transportation of Food Read More »
FDA is scheduled to issue regulations finalizing its proposed Nutrition Facts label soon according to the US Regulatory Agenda. Many food companies and trade associations are eagerly awaiting the final rules to see how the agency will handle the most controversial provisions. One part of the proposed rules would require the disclosure of added sugars,
FDA has revised a guidance document to acknowledge that “Dietary Supplement” alone properly may be used as the statement of identity in labeling a dietary supplement. Announcement of this revision was published in a Federal Register notice on March 7th. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended section 403 of the
“Dietary Supplement” is a Proper Statement of Identity Read More »
There is a need for an interstate structure to provide coordination and regulatory oversight of medical marijuana (cannabis) use in the 23 states that have approved its use by either referendum or legislation. Five jurisdictions — Colorado, Washington, Oregon, Alaska and the District of Columbia — have now also authorized the recreational use of cannabis.
Interstate Structure to Oversee and Regulate Medical Marijuana Read More »
On behalf of the Agriculture practice group at OFW Law, following is a copy of our Winter 2016 newsletter. We hope you find it useful. To receive this periodic newsletter by e-mail, please contact Carrie Morgan.
Regulatory Round-Up Newsletter, Winter 2016 Read More »
By OFW Law and HACCP Consulting Group Under the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) made the decision that registered facilities would be required to implement food safety plans based on preventive controls rather than the principles of HACCP. Since HACCP is already mandatory for identified hazards in seafood, juice and foods
It’s Not What You Call It – It’s How You Manage It Read More »
Dr. Doom and Ms. Gloom have been addressing the fact that both FSIS and FDA are paying more attention to Listeria control in ready-to-eat facilities. In previous blogs, they have discussed facility maintenance and repair as well as employee practices. Doom and Gloom also recommend that facilities that manufacture RTE foods maintain a Listeria Control
Doom and Gloom Suggest “Keeping Watch on Listeria” Read More »
Last year, Dr. Doom and Ms. Gloom offered tips for facility maintenance and repair to assist facilities in being prepared for the selection of targeted sampling by USDA’s Food Safety and Inspection Service (FSIS) and/or Food and Drug Administration (FDA). We hinted that the agencies would target sampling on areas of poor design or in
Flo and H’Jean (aka Doom and Gloom) Read More »
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 »
