Category Archives: FDA

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FDA Issues Draft Guidance Encouraging Innovative Approaches to Expand Access to OTC Drugs

FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that sponsors of new drug applications may wish to consider to demonstrate the safety and effectiveness of nonprescription drugs.  In announcing the draft guidance, FDA Commissioner Scott Gottlieb explained that the agency sees an opportunity to “foster … Continue Reading

Prop 65 Court Win for Cereal Manufacturers Sets the Table for Further Challenges to Warning Requirements

In a remarkable and perhaps precedent-setting decision, a California appellate court sided with cereal manufacturers in ruling last week that Proposition 65 cancer warnings for acrylamide were preempted by federal policy encouraging the consumption of more whole grains.  In overturning a lower court ruling finding no preemption, the three-judge panel of the state appeals court … Continue Reading

FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA Rule).  This is the first of three installments of guidance the FDA plans to release related to the IA Rule. The new guidance covers the development of a food defense plan, which includes … Continue Reading

Senator Schumer Introduces Legislation to Decriminalize Marijuana at the Federal Level

Making good on this April 20th announcement, Senator Chuck Schumer (D-NY) introduced legislation that would upend current federal regulation of marijuana. Specifically, the Marijuana Freedom and Opportunity Act removes marijuana from the list of scheduled substances under the Controlled Substances Act, effectively decriminalizing it at the federal level.  Under the bill, states would continue to … Continue Reading

FDA to Hold Public Meeting on Foods Produced Using Animal Cell Culture Technology

The FDA recently announced that it will hold a public meeting entitled, “Foods Produced Using Animal Cell Culture Technology,” on July 12, 2018 to provide the public with an opportunity to offer feedback related to the production of foods using animal cell culture technology.  Stakeholders will also have the opportunity to submit written comments until … Continue Reading

USDA and FDA Announce Proposed Bioengineered Disclosure Rules and Labeling Rule Compliance Date Changes

Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4, the Agricultural Marketing Service (AMS) of the USDA proposed a rule regarding the National Bioengineered Food Disclosure Standard providing labeling requirements for disclosing whether a food product has been bioengineered. The proposed … Continue Reading

FDA Finalizes Guidance on Newly Effective Menu Labeling Requirements

The FDA today released a final version of a November 2017 guidance document that promises a flexible approach to enforcement of agency regulations prescribing calorie declarations at restaurants and similar retail food establishments.  The release of the final guidance coincides with the effective date of the regulations.  Covered establishments are now expected to comply with … Continue Reading

Unanimous Recommendation for Cannabis-Based Epilepsy Drug; Trump Administration Lifts Threat of Cannabis Enforcement in States With Legalization; Schumer To Introduce Bill Decriminalizing Marijuana

On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention.  The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals.  The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found … Continue Reading

Advertising Marijuana Businesses: The Federal Criminal Law You Need to Know

As the gravitational pull toward marijuana legalization continues, new sources of revenue continue to emerge. Former Republican House Speaker John Boehner (and former opponent of legalization) recently announced that he joined the board of directors for a cannabis company, and sales of cannabis in California are expected to exceed $3.5 billion in 2018 and to … Continue Reading

Think Your Prescription Drug Advertising is Beyond NAD’s Purview? NAD Disagrees.

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a universe unto itself, overseen by the FDA pursuant to the Prescription Drug Marketing Act. As prescription drug companies have increased their direct-to-consumer outreach through social media, native advertising, and … Continue Reading

FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and that made unsubstantiated, deceptive claims in violation of the FTC Act.  In addition to the 11 joint warning letters … Continue Reading

“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the effectiveness of those inspections and the capacity for FDA to meet future required timeframes.  The report comes this week from the U.S. Department of Health and Human Services Office of Inspector General, … Continue Reading

FDA: Still in Action on Food Safety Violations

Vigorous food safety enforcement for basic violations continues under the leadership of new FDA Commissioner, Dr. Scott Gottlieb. On June 20, on the heels of an adverse FDA inspection, FDA announced that the U.S. Marshals Service had seized the food products held by Professional Warehouse and Distribution, Inc., at a food warehouse facility in St. … Continue Reading

FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements.  The rule initially set a general compliance date of July 26, 2018, although manufacturers with annual food sales of less than $10 million were given an … Continue Reading

Senate Expected to Vote on Gottlieb Nomination Next Week

Today, Senate Majority Leader Mitch McConnell (R-KY) filed cloture on the nomination of Dr. Scott Gottlieb to be the next FDA Commissioner.  A cloture vote to end debate will occur Monday afternoon, with 50 votes needed to advance the nomination.  It will be followed by a final vote on the nomination, which typically occurs after 30 hours … Continue Reading

FDA Commissioner Nominee Gottlieb’s Written Responses Signal Support for Food Safety and Science-Based Approach to Consumer Communications

Dr. Scott Gottlieb, recently submitted written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee as a follow up to his hearing on April 5.  As a follow up to our April 13 post, below are selected Q&A exchanges based on questions submitted by Senators Elizabeth Warren (D-MA) and … Continue Reading

Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as Commissioner of the Food and Drug Administration.  As part of the hearing, Gottlieb was questioned on an array of topics from his prior service at FDA to his alleged financial interests … Continue Reading

Oregon Attorney General Announces $545,000 Settlement with Retailer

The Oregon AG recently announced a $545,000 settlement with the Vitamin Shoppe over allegations that the store violated Oregon state law by selling dietary supplements containing ingredients that FDA has deemed unsafe or unlawful. The new settlement agreement places significant burdens on the Vitamin Shoppe to monitor developments on ingredient status. The burdens are the same regardless of whether the … Continue Reading

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

Dr. Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition, spoke on Thursday to the DC section of the Institute of Food Technologists.  Responding to questions from the audience, Dr. Mayne was asked to comment on how the Trump administration’s emphasis on deregulation is likely to impact CFSAN’s work.  Speaking generally, Dr. … Continue Reading

FDA to Redefine “Healthy;” Requests Public Comment and Issues New Guidance

FDA hinted in May that it was planning to reconsider its longstanding and controversial criteria for using the term “healthy.”  Today, it announced the beginning of the formal process to make changes to the definition of the term.  The agency opened a new docket and is publishing a Request for Information and Comments relating to … Continue Reading

Senators Reach Compromise on GMO Labeling Bill

Yesterday, U.S. Senate Agriculture Committee Chairman Pat Roberts, R-Kan., and Ranking Member Debbie Stabenow, D-Mich., announced a bipartisan compromise bill regarding labeling of bioengineered foods, sometimes referred to as “genetically modified organisms” or “GMOs.”  They stated, “This bipartisan agreement is an important path forward that represents a true compromise. Since time is of the essence, … Continue Reading

FDA Releases Final Rules Revising Nutrition Facts Label and Certain Serving Sizes; Industry Given Two to Three Years to Comply

FDA announced today that it was finalizing two previously proposed rules that will require industry to overhaul Nutrition Facts panels on all food products sold in the United States and recalculate serving sizes for some foods.  The new rules mark the first time that FDA has engaged in rulemaking to update the framework for nutrition … Continue Reading

FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously released rules governing current good manufacturing practice, hazard analysis and risk-based preventive controls for human food and animal food (“the … Continue Reading
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