On April 22, OFW Principal John Dillard presented a webinar addressing the federal regulatory changes that have been implemented to respond to the COVID-19 pandemic. The webinar also discussed guidance from USDA, FDA, the Department of Homeland Security, and the Center for Disease Control as well as some of the best practices that have been
John G. Dillard, a principal at OFW. will be presenting a review of several federal agencies’ responses to the COVID-19 crisis that affect food producers and manufacturers. The webinar, “COVID-19: Regulatory Changes Impacting Food Production and Distribution” will be offered by the National Agricultural Law Center on Wednesday, April 22, 2020 at 12pm EST. John
The FDA is currently posting updates in a Q&A format on its Food Safety and the Coronavirus Disease 2019 (COVID-19) webpage. The Q&A provides information to food production/processing facilities and retail food establishments regarding best practices during the ongoing public health emergency. For example, the website provides some salient advice on social distancing in food
FDA COVID-19 Food Safety Q&A Read More »
Today the FDA issued a guidance to provide temporary flexibility regarding the packaging and labeling of shell eggs sold to consumers in retail food establishments. Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID-19 Public Health Emergency: Guidance for Industry (Apr. 2020) The guidance essentially permits retailers
Complete Label Exemption for Shell Eggs During Pandemic Read More »
The Food and Drug Administration (FDA) has issued a guidance to chain restaurants and similar retail food establishments (“covered establishments”) that sell standard menu items covered under the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide flexibility regarding these menu labeling requirements during the COVID-19
Menu Labeling Flexibility for Covered Establishments During Pandemic Read More »
On Friday, the Food and Drug Administration (FDA) announced the issuance of a new Guidance document pertaining to nutrition labeling during the COVID-19 health crisis. It is intended to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the current pandemic. This guidance does not
The Food and Drug Administration (FDA) published a Notice that set forth the process that it and the Center for Food Safety and Applied Nutrition (CFSAN) will use in expediting the availability of guidance documents concerning the ongoing COVID-19 public health emergency. It will include essential recommendations and policies and will eliminate requisite notice and
FDA and CFSAN on Issuing Guidance Documents Concerning COVID-19 Read More »
Today, the President signed an Executive Order to authorize the Sec. of HHS to designate medical equipment as “critical” or “essential” to the national response to the crisis. Under DPA § 102, the President can take action to prohibit the hording of materials designated as “scarce” or “essential.” Sec. 102 prohibits the accumulation of such
Defense Production Act Update – 3/23/2020 Read More »
The availability of Coronavirus Disease-2019 (COVID-19) diagnostic tests is critical to an effective response to the current pandemic. FDA has taken measures to permit the distribution of such tests in advance of receiving authorization to do so from the agency in an attempt to remove bureaucratic barriers that could affect the nation’s ability to mount
COVID-19 Update for Diagnostic Device Manufacturers Read More »
In response to requests received from multiple stakeholders, FDA has agreed, in effect, to exercise enforcement discretion relative to the new Nutrition Facts panel (NFP) for six months following the initial January 1, 2020 compliance date. The agency is doing so through a new Question and Answer (Q&A) in the Compliance section of its Industry
Initial NFP Compliance Date – 6 Months Enforcement Discretion Read More »
Sprouts are associated with numerous foodborne illness outbreaks. According to the U.S. Food and Drug Administration (FDA), more than 2,600 documented illnesses have been associated with consuming contaminated sprouts since 1996. Much of the challenge to controlling risks lies in the fact that seeds are often the source of contamination in sprout products. In FDA’s
FDA Publishes Draft Guidance For Sprout Seed Producers Read More »
A qualified health claim is one of the few tools FDA gives food and supplement companies to link an ingredient to a reduced disease risk on a label. For EPA and DHA omega-3s, FDA authorizes two sets of qualified health claim language covering coronary heart disease and hypertension – but the enforcement discretion letters that
EPA and DHA Qualified Health Claims: A Compliance Guide for Food and Supplement Labels Read More »
Today, FDA published notice of the availability of a final guidance for industry, entitled: The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products (June 2019). The final guidance provides industry with some rational relief from the added sugars nutrition labeling requirements that predated it. That relief
On April 3, 2019, the Food and Drug Administration (FDA) released a proposed rule that lowers the maximum amount of fluoride allowed in some bottled water products. If finalized, the rule would place an upper limit of 0.7 milligrams per liter of fluoride in bottled water to which fluoride is added. The proposed limits would
FDA Proposes New Fluoride Limits for Bottled Water Read More »
Earlier this week, the FDA made significant movement on issues and policy involving cannabis and its components, including cannabidiol (CBD). The agency issued a notice in the Federal Register announcing a hearing and requesting comments on “scientific data and information about products containing cannabis or cannabis-derived compounds.” 84 Fed. Reg. 12,969. FDA and the Federal
FDA Begins to Move on CBD Policy and Enforcement Read More »
FDA has announced a public meeting to discuss its recent Draft Guidance for industry on the agency’s intentional adulteration of food regulation, promulgated under FSMA, i.e., “Mitigation Strategies to Protect Against Intentional Adulteration” (Final Rule), codified at 21 C.F.R. Part 121. The public meeting is taking place on April 17, 2019, from 8:30 AM to
FDA’s Final Rule on Intentional Adulteration of Food: Public Meeting and Guidance Read More »
As initially announced last week by outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., the compliance dates for FDA’s agricultural water quality requirements under the “Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption” rule (Produce Rule) are being extended. Today, FDA published a final rule in the Federal
FDA Extends Compliance Date for The Produce Rule’s Agricultural Water Requirement Read More »
“Low-carb food labeling” sits in a regulatory gray zone that creates real legal risk for food manufacturers. Keto, paleo, and low-carbohydrate product categories generate billions in annual consumer sales — yet FDA has never established a regulatory definition for what “low-carb” means on a food label. That gap is not an oversight. It is the
Low-Carb Food Labeling: What FDA Rules Mean for Food Manufacturers Read More »
Yesterday FDA withdrew its directive to remove and reserve the Current Good Manufacturing Practice (cGMP) for Human Food regulations found in 21 C.F.R. Part 110. This is not groundbreaking as the cGMP requirements in Part 110 were codified into Part 117, Current Good Manufacturing Practices, Hazard Analysis, and Risk Based Preventive Controls for Human Food.
Part 110 Lives Another Day Read More »
Yesterday, FDA announced in the Federal Register, the Agency’s 2019 user fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program. Under the current third-party certification program, as required by the Food Safety Modernization Act (FSMA), FDA established a
FDA Announces FY 19 User Fee Rates for Third Party Certification Program Read More »
CFSAN/FDA’s Office of Food Additive Safety (OFAS) has replaced the original Everything Added to Food in the U. S. (EAFUS) inventory with an upgraded version – the Substances Added to Food inventory. This new inventory — which contains about 4000 substances and is searchable — includes information on: Generally recognized as safe (GRAS) substances in
EAFUS Inventory Replaced by “Substances Added to Food” Inventory Read More »
FDA has announced a public meeting, entitled “FDA’s Comprehensive, Multi-Year Nutrition Innovation Strategy,” (Strategy) to be held on July 26, 2018, from 8:30 a.m. until 5:30 p.m. EDT, at the Hilton Washington DC/Rockville Hotel, 1750 Rockville Pike, Rockville, MD 20852. The public meeting also will be made available via live webcast. In March 29, 2018
FDA Nutrition Innovation Strategy Read More »
The FDA Food Safety Modernization Act contained provisions aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. This was the first time that covered companies were legally required to create a food defense plan. Covered companies generally include both domestic and
Intentional Adulteration Mitigation Strategies – Initial Draft Guidance Read More »
FDA has published a guidance that specifies eight (8) additional substances that qualify as dietary fiber for purposes of nutrition labeling: The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels: Guidance for Industry (June 2018). When it revised its Nutrition Facts and Supplement Facts regulatory requirements
Isolated or Synthetic Non-Digestible Carbohydrates that Qualify as Dietary Fiber Read More »
Food manufacturers using the following seven (7) synthetic flavoring substances and adjuvants should take note that the safety of these ingredients is being challenged: Benzophenone (a/k/a diphenylketone), Ethyl acrylate, Eugenyl methyl ether (a/k/a 4-allylveratrole, methyl eugenol, or Methyleugenol), Myrcene (a/k/a 7-methyl-3-methylene-1,6-octadiene), Pulegone (a/k/a p-menth-4(8)-en-3-one), Pyridine, and Styrene. Each of these substances is authorized for food
Synthetic Flavors’ Safety Questioned – Strategy Needed to Address Consequence Read More »
FDA recently announced a potential massive overhaul to its Medical Device regulations. Specifically, the agency intends to “harmonize and modernize” its medical device Quality System Regulation (21 C.F.R. Part 820) with an international consensus standard for medical device manufacturing (ISO 13485). The rulemaking entitled “Harmonizing and Modernizing Regulation of Medical Device Quality Systems” appears on
FDA Announces Medical Device Quality System Regulation Change Read More »
On May 4, 2018, the FDA issued its final rule extending the compliance date for the updated nutrition information on the labels of most conventional foods and dietary supplements. The final rule is consistent with FDA’s October 2, 2017 proposed rule, and implements a 1.5 year (approximate) compliance date extension: From July 26, 2018, to
FDA Finalizes Nutrition Facts Compliance Date Extension by 1.5 Years Read More »
On the same day that FDA’s menu labeling regulation became effective for compliance by industry, the agency published notice of the availability of its finalized Menu Labeling: Supplemental Guidance for Industry (May, 2018). This guidance is “supplemental” because FDA also already has published A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods –
Menu Labeling – Supplemental Guidance Read More »
FDA does not set a single caffeine cap for dietary supplements. The rules sit across multiple statutes and regulations – the Dietary Supplement Health and Education Act (DSHEA), 21 CFR Part 182, the FD&C Act’s adulteration provisions, and FDA’s guidance on highly concentrated caffeine products. For supplement manufacturers, the real compliance risk is not “how
FDA Caffeine Regulations for Dietary Supplements Read More »
The Food Labeling Modernization Act of 2018 (H.R. 5425) was introduced on April 4, 2018, by Rep. Frank Pallone, Jr. (D-NJ), the ranking member of the House Energy and Commerce Committee. A joint press statement announcing the bill was released by Rep. Pallone and co-sponsor Rep. Rosa DeLauro (D-CT), the ranking member of the House
By former USDA Secretary John R. Block All the time, we hear the loud voices of consumer groups that insist the public must be informed about the food we eat. “Label it organic.” “If it has GMOs, the consumer must know.” “You should not label it natural if it is not natural,” whatever ‘natural’ means. Now,
John Block: Clean Meat Read More »
In a speech, entitled “Reducing the Burden of Chronic Disease,” delivered on March 29th by FDA Commissioner Scott Gottlieb before the National Food Policy Conference in Washington, D.C., FDA kicked-off its Nutrition Innovation Strategy. FDA has identified several areas where it believes there is opportunity to improve public health and encourage industry innovation towards reducing
FDA Maintains Focus on Nutrition to Foster Human Health Read More »
Dietary fiber is a macronutrient that permissibly may be declared in the Nutrition Facts on a conventional food’s label, and in the Supplement Facts on a dietary supplement’s label. 21 C.F.R. §§ 101.9(c)(6)(i), 101.36(b)(2)(i). To clarify what may be included in nutrition labeling declaration of Dietary Fiber content, § 101.9(c)(6)(i) provides: Dietary fiber is defined
Dietary Fiber Permissible in Nutrition/Supplement Facts Read More »
CFSAN/FDA has made available a guidance document and a small entity compliance guide to assist industry in complying with its revised nutrition labeling requirements for conventional foods and dietary supplements: Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category (Feb. 2018) [hereinafter “RACC Guide”]; and Guidance for Industry: Food Labeling:
RACC and Serving Size Guidance Read More »
By Nina Fedoroff and Alison Van Eenennaam, as published in the Des Moines Register In his speech at the recent American Farm Bureau convention, President Trump said his administration was “streamlining regulations that have blocked cutting-edge biotechnology.” Why is this necessary? Paraphrasing New York Times columnist Paul Krugman’s words on economic policy, it’s because we’re still living with “zombie” biotech
How the Federal Government Can Get Biotech Regulation Right Read More »
