Janet Woodcock is Named Acting FDA Commissioner, As Stephen Hahn Steps Down

Healthcare, Life Sciences / Michael J. O'Flaherty

In typical fashion, as the new administration took over, i.e., as President Biden was sworn in on Wednesday, Dr. Stephen M. Hahn resigned as FDA Commissioner. His resignation was part of the routine departure of political appointees seen when a new President takes office. Dr. Janet Woodcock has become Acting Commissioner on an interim basis, […]

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QHC for Cranberry Products and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women

Healthcare, Agriculture & Agribusiness / Michael J. O'Flaherty

FDA has published a letter of enforcement discretion, which it sent to legal counsel for Ocean Spray Cranberries, Inc., that authorizes a qualified health claim (QHC) for specific cranberry products when consumed in specific amounts by specific people. The substantiation for the diet-disease relationship warranted a “limited and inconsistent” or “limited” scientific evidence qualifier. Based on

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silver food packaging on a wooden background

New Guidance Documents from the FDA on Foods Labeling and Postponement of Compliance Date for Revised Nutrition/Supplement Facts Panels

FDA, For Export / Michael J. O'Flaherty

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

New Guidance Documents from the FDA on Foods Labeling and Postponement of Compliance Date for Revised Nutrition/Supplement Facts Panels Read More »

FDA and CFSAN on Issuing Guidance Documents Concerning COVID-19

FDA, For Export / Michael J. O'Flaherty

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

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Large assortment of honey and similar syrups

Added Sugars in Pure Honey and Maple Syrup, and Other Single-Ingredient Sugars and Syrups, and in Dried Cranberry and Cranberry Beverage Products

FDA, For Export / Michael J. O'Flaherty

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

Added Sugars in Pure Honey and Maple Syrup, and Other Single-Ingredient Sugars and Syrups, and in Dried Cranberry and Cranberry Beverage Products Read More »

FDA’s Final Rule on Intentional Adulteration of Food: Public Meeting and Guidance

FDA, For Export, Uncategorized / Michael J. O'Flaherty

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

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Organic chocolate cake labeled with low carbs

Low-Carb Food Labeling: What FDA Rules Mean for Food Manufacturers

FDA, For Export / Michael J. O'Flaherty

“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

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FDA Nutrition Innovation Strategy

FDA, For Export / Michael J. O'Flaherty

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

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Isolated or Synthetic Non-Digestible Carbohydrates that Qualify as Dietary Fiber

FDA, For Export / Michael J. O'Flaherty

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

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Collection of artificially flavored candy

Synthetic Flavors’ Safety Questioned – Strategy Needed to Address Consequence

FDA, For Export / Michael J. O'Flaherty

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

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Dietary Fiber Permissible in Nutrition/Supplement Facts

FDA, For Export / Michael J. O'Flaherty

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

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“Grandfathered” Dietary Ingredients – It’s About Time

FDA, For Export / Michael J. O'Flaherty

The Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 – almost a quarter century ago. It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) in a number of significant ways that set the stage for present marketing of this important category of consumer goods. However, aspects of DSHEA never were

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Food Facility Registration Rules To Be Updated by FDA

FDA / Michael J. O'Flaherty

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.

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Risk Communication about Methylmercury in Seafood

EPA, FDA / Michael J. O'Flaherty

FDA has announced that its Risk Communication Advisory Committee (RCAC) will be holding a public meeting on November 3-4, 2014, at its White Oak Campus in Silver Spring, MD. The RCAC meeting will focus on messages about the importance of eating adequate amounts of fish and shellfish, while avoiding certain varieties with higher amounts of

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FDA Food Facility Registrations Must Be Renewed Soon

FDA / Michael J. O'Flaherty

It is October 1st and time to renew your food facility registration(s) with FDA. Facilities (domestic and foreign) engaged in manufacturing, processing, packing, or holding food (human or animal) for consumption in the United States must register with FDA, unless exempt. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.

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Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient

FDA, USDA / Michael J. O'Flaherty

The USDA’s Food Safety and Inspection Service (FSIS) plans, effective November 10, 2014, to halt issuing export certificates for FDA-regulated foods that contain an egg product(s) as an ingredient because USDA’s Agricultural Marketing Service (AMS) now provides this service. FDA regulates the safe production, sanitary processing, and labeling of food products containing egg products. Nevertheless,

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FDA Updates 4 Proposed Rules Implementing FSMA

FDA / Michael J. O'Flaherty

The Food and Drug Administration (FDA) today made available proposed revisions to four (of seven) proposed rules implementing the FDA Food Safety Modernization Act (FSMA). The proposed revisions address: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (for a summary, click here); Standards for the Growing, Harvesting, Packing, and

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OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

FDA, OFW Law News, Public Policy / Michael J. O'Flaherty

Thirty-five (35) years ago, the Washington, DC law firm presently known as Olsson Frank Weeda Terman Matz PC, or simply “OFW Law,” originated as Olsson and Frank, P.C. It was comprised of two (2) founding attorneys, Philip C. (Phil) Olsson and Richard L. (Rick) Frank, who left another DC law firm to start their own.

OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team Read More »

Reopening of Comment Period on Reportable Food Registry ANPR

FDA / Michael J. O'Flaherty

The Food and Drug Administration (FDA) has reopened the comment period for an additional sixty (60) days on its advance notice of proposed rulemaking (ANPR), entitled “Implementation of the Food and Drug Administration Food Safety Modernization Act (FSMA) Amendments to the Reportable Food Registry (RFR) Provisions of the Federal Food, Drug, and Cosmetic Act.” 79

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FDA Updates Its Guidance on Prior Notice of Imported Foods

FDA / Michael J. O'Flaherty

The Food and Drug Administration (FDA) has published an updated guidance document, Draft Guidance for Industry: Prior Notice of Imported Food Questions and Answers (Edition 3). This draft guidance is being distributed for comment purposes only. Although comments on FDA guidance documents may be submitted at any time (see 21 C.F.R. § 10.115(g)(5)), to ensure

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Draft Methodological Approach for Designating High-Risk Foods — Comment Period Extended

FDA / Michael J. O'Flaherty

The Food and Drug Administration (FDA) has published notice of a 45-day extension, until May 22, 2014, of the comment period on its Draft Methodological Approach to Identifying High-Risk Foods under Section 204(d)(2) of FSMA. 79 Fed. Reg. 16,800 (Mar. 26, 2014). Notice of the draft guidance document originally was published in the Federal Register

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Intentional Adulteration – Comment Period Extended

FDA / Michael J. O'Flaherty

The Food and Drug Administration (FDA) has published notice of a 90-day extension, until June 30, 2014, of the comment period on its proposed rule addressing intentional adulteration of food and on an associated draft document, both published in the Federal Register on December 24, 2013 (see blog postings dated January 7, January 31, and February

Intentional Adulteration – Comment Period Extended Read More »

Dietary Supplements: New Online Method Now Available for Reporting Serious Adverse Events

FDA / Michael J. O'Flaherty

Content area

Dietary Supplements: New Online Method Now Available for Reporting Serious Adverse Events Read More »

2013 Voluntary National Retail Food Regulatory Program Standards Are Published by FDA

FDA / Michael J. O'Flaherty

Content area

2013 Voluntary National Retail Food Regulatory Program Standards Are Published by FDA Read More »

Changes to FDA’s Regulation of Acidified and Low-Acid Canned Foods Are on the Horizon

FDA / Michael J. O'Flaherty

A draft guidance document, recently published by FDA for public comment, describes changes being contemplated for the procedures that manufacturers of acidified foods and low-acid canned foods prospectively will use to submit information about the processes they use to ensure that the foods they produce are safe for consumers. The draft guidance addresses: Administrative procedures

Changes to FDA’s Regulation of Acidified and Low-Acid Canned Foods Are on the Horizon Read More »

Nutrition Labeling Reform Is on the Horizon

FDA / Michael J. O'Flaherty

Two long-awaited, proposed rules to revise the regulatory requirements for nutrition labeling of conventional foods and of dietary supplements have been sent by FDA to the Office of Information and Regulatory Affairs within OMB for final review before publication. The first proposed rule, “Food Labeling; Revision of the Nutrition and Supplement Facts Labels,” would amend

Nutrition Labeling Reform Is on the Horizon Read More »

FDA Declines To Define “Natural” for Foods Formally, Leaving Its Informal Policy in Place

FDA / Michael J. O'Flaherty

FDA once again has “respectfully declined” to define the term “natural” when used in food labeling. In a January 6, 2014, letter from Leslie Kux, Assistant Commissioner for Policy, to three federal judges handling civil litigation brought against manufacturers over “natural”-type claims made for foods containing bioengineered ingredients, FDA denied their requests essentially to define “natural”

FDA Declines To Define “Natural” for Foods Formally, Leaving Its Informal Policy in Place Read More »

Regulatory Mismanagement of Medical Foods?

FDA, Health Care / Michael J. O'Flaherty

FDA published in yesterday’s Federal Register notice of a 30 day (albeit 60 days had been requested) reopening of the comment period on its Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition, updated in August 2013. Prior versions of the guidance document had been published in May 1997 and May 2007.

Regulatory Mismanagement of Medical Foods? Read More »

DMAA Dietary Ingredient Withdrawn from Market

FDA / Michael J. O'Flaherty

FDA’s publication last week, on April 11th, of a warning to consumers about dietary supplements containing dimethylamylamine (DMAA) (a/k/a 1,3-dimethylamylamine, methylhexanamine or geranium extract) followed up on Warning Letters issued on April 24, 2012, by FDA’s Center for Food Safety and Applied Nutrition (CFSAN) to 10 company purveyors (i.e., Exclusive Supplements, Inc., Fahrenheit Nutrition, Gaspari

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What Kind of Control Over What We Eat and Drink Is Permissible in Our Democracy?

Health Care / Michael J. O'Flaherty

Earlier this week, the New York State Supreme Court, New York County, in an opinion of the Honorable Milton A. Tingling, JSC, enjoined and permanently restrained New York City (NYC) from implementing NYC Health Code § 81.53, commonly referred to as the “Portion Cap Rule” for sugary sodas, a regulation supported by Mayor Richard Bloomberg

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Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims

FDA / Michael J. O'Flaherty

The number of class action lawsuits targeting food labeling claims has risen dramatically over the past few years. These are cases alleging that a food product’s labeling (and/or advertising) violates state consumer protection laws. As a result, when a food company now considers whether to include an aggressive claim in commercial marketing, it should consider

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Michael J. O'Flaherty

Janet Woodcock is Named Acting FDA Commissioner, As Stephen Hahn Steps Down

QHC for Cranberry Products and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women

New Guidance Documents from the FDA on Foods Labeling and Postponement of Compliance Date for Revised Nutrition/Supplement Facts Panels

FDA and CFSAN on Issuing Guidance Documents Concerning COVID-19

Added Sugars in Pure Honey and Maple Syrup, and Other Single-Ingredient Sugars and Syrups, and in Dried Cranberry and Cranberry Beverage Products

FDA’s Final Rule on Intentional Adulteration of Food: Public Meeting and Guidance

Low-Carb Food Labeling: What FDA Rules Mean for Food Manufacturers

FDA Nutrition Innovation Strategy

Isolated or Synthetic Non-Digestible Carbohydrates that Qualify as Dietary Fiber

Synthetic Flavors’ Safety Questioned – Strategy Needed to Address Consequence

Dietary Fiber Permissible in Nutrition/Supplement Facts

“Grandfathered” Dietary Ingredients – It’s About Time

Food Facility Registration Rules To Be Updated by FDA

Risk Communication about Methylmercury in Seafood

FDA Food Facility Registrations Must Be Renewed Soon

Export Certificates for FDA-Regulated Foods Containing Egg Products as an Ingredient

FDA Updates 4 Proposed Rules Implementing FSMA

OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

Reopening of Comment Period on Reportable Food Registry ANPR

FDA Updates Its Guidance on Prior Notice of Imported Foods

Draft Methodological Approach for Designating High-Risk Foods — Comment Period Extended

Intentional Adulteration – Comment Period Extended

Dietary Supplements: New Online Method Now Available for Reporting Serious Adverse Events

2013 Voluntary National Retail Food Regulatory Program Standards Are Published by FDA

Changes to FDA’s Regulation of Acidified and Low-Acid Canned Foods Are on the Horizon

Nutrition Labeling Reform Is on the Horizon

FDA Declines To Define “Natural” for Foods Formally, Leaving Its Informal Policy in Place

Regulatory Mismanagement of Medical Foods?

DMAA Dietary Ingredient Withdrawn from Market

What Kind of Control Over What We Eat and Drink Is Permissible in Our Democracy?

Class Action Consumer Litigation: A Rising Enforcement Risk for Aggressive Food Labeling Claims

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