Category Archives: FDA

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FDA Releases Draft Guidance on Determining What Constitutes a “Qualified Facility” under FSMA Preventive Controls Rules

On Friday, the FDA announced the availability of a draft guidance describing its current thinking on how to determine whether a business is a “qualified facility” that is subject to modified requirements under its previously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

FDA Finalizes Additional Guidance on Medical Foods; Continues to Take Narrow View of Category

FDA has finalized its guidance document relating to medical foods, a special class of products defined under the Orphan Drug Act. Although most of the content of the final guidance mirrors the draft guidance released in August 2013, the final guidance clarifies the following points: Medical foods are exempt from the labeling requirements for nutrient … Continue Reading

FDA to Chew Over Meaning of “Healthy”

Although “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat.  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it … Continue Reading

FDA Final Rule for Foods and Cosmetics Aims to Reduce Risk of Mad Cow Exposure

Today the FDA issued its final rule prohibiting the use of certain cattle material in human foods, dietary supplements, and cosmetics.  The rule is focused on reducing the risk of human exposure to bovine spongiform encephalopathy (BSE), a fatal neurological disorder sometimes known as “mad cow disease.”  The rule will take effect on April 18, … Continue Reading

Identity Crisis Over: Dietary Supplements Can Be “Dietary Supplements”

In its dietary supplement labeling guide, first issued in April 2005, FDA advised that it would not consider the term, “dietary supplement,” alone, to be an appropriately descriptive “statement of identity.” FDA, however, has now reversed course. Revised guidance released last week now provides as follows: Can the term “dietary supplement” by itself be considered the … Continue Reading

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat post-traumatic stress disorder, lupus, cancer, and other conditions rendered the products unapproved new drugs. This February, FDA again turned its attention to CBD products, issuing … Continue Reading

FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon.  The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the new animal … Continue Reading

FDA Proposes Gluten-Free Labeling Standards for Fermented and Hydrolyzed Foods

On November 18, 2015, the FDA issued a proposed rule to set standards for making a “gluten-free” claim for foods that are fermented, hydrolyzed, or distilled, or that otherwise contain fermented or hydrolyzed ingredients. The proposed rule builds on the FDA’s 2013 final rule defining the term “gluten-free” for voluntary use in labeling of foods. … Continue Reading

FDA Issues Final Food Biotechnology Labeling Guidelines for Plant Foods; Discourages “GMO Free” Claims

On November 19, 2015, FDA issued its final guidance for industry concerning the requirements for voluntarily indicating whether food products have or have not been derived from genetically engineered plants.  The final guidance updates the FDA draft guidance originally issued on January 18, 2001.  Under the guidance, food manufacturers may voluntarily label their foods with … Continue Reading

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal agencies, and academia, and also to “remind manufacturers of this policy.”  FDA’s “fortification policy” was first published in a 1980 Federal Register … Continue Reading

The DOJ Press Conference on Dietary Supplements: Heavy on Hype, Short on Facts

On Tuesday, a nimiety of federal agencies converged at a press conference at the Department of Justice to announce new and ongoing cases against dietary supplement marketers. Federal agencies included FDA, the FTC, the U.S. Postal Inspection Service, the IRS, the Department of Defense, and the U.S. Anti-Doping Agency. The event was flush with provocative … Continue Reading

FDA Requests Public Comment on How “Natural” Claims Should be Regulated; Opening 90-Day Comment Period

FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register.  In particular, FDA seeks information and public comment relating to a number of specific issues, including the following: Should FDA define the … Continue Reading

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug procedures.  The stay serves to encourage scientific research into the relationship between diet and health while FDA considers numerous comments questioning … Continue Reading

WLF Working Paper Assesses Ninth Circuit Preemption Decision

In Reid v. Johnson & Johnson, the Ninth Circuit heard an appeal of one of the many state law-based consumer class actions over food labeling. A new Washington Legal Foundation Working Paper by Sarah Roller assesses the Ninth Circuit’s refusal in Reid to grant preemptive effect to a 2003 FDA letter of enforcement discretion. Johnson & … Continue Reading

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory framework to homeopathic drugs.  The comment responds to FDA’s March 27, 2015 announcement of a public hearing on the topic and request … Continue Reading

FDA Extends Menu Labeling Deadline

Responding to input from stakeholders, the FDA has decided to extend the deadline for complying with its Menu Labeling Final Rule from December 1, 2015 to December 1, 2016.  In general, the Rule requires chain restaurants and other food service establishments to provide calorie information on menus and menu boards.  We discussed the specific requirements … Continue Reading

FDA Releases Draft Guidance on Voluntary Qualified Importer Program

The FDA announced last week the release of a draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act (FSMA).  The draft guidance describes how FDA intends to determine eligibility to participate in the program, along with the benefits of participating, instructions for completing … Continue Reading

FDA’s Marijuana Q&A: More Questions than Answers?

The FDA recently released its current thinking on marijuana in a variety of forms in a web-based document titled “FDA and Marijuana: Questions and Answers.”  The most notable question and answer related to whether cannabidiol (“CBD”), a non-narcotic extract of industrial hemp, can be marketed as a dietary supplement, a position that was unclear following … Continue Reading

FDA Extends Risk-Based Medical App Approach to Medical Device Data Systems in New Guidance

The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that when it comes to health IT products, FDA’s policy aims to keep unnecessary FDA regulation from impeding the progress of new technologies that offer … Continue Reading

Sunscreen Innovation Act Changes FDA Review Process for More Than Just OTC Sunscreens

On November 26, 2014, the President signed into law the Sunscreen Innovation Act (Pub. L. No. 113-195).  The Act is primarily intended expedite FDA procedures for approving new sunscreen active ingredients and ingredient blends for use in nonprescription sunscreen products under the Federal Food Drug and Cosmetics Act, and address the current backlog of sunscreen … Continue Reading

FDA Issues Final Rules Prescribing Broad Labeling Requirements for Menus and Vending Machines

The FDA recently released two long-awaited final rules that establish detailed requirements for calorie labeling on menus and menu boards and vending machines. Promulgated pursuant to provisions of the Affordable Care Act (ACA) that amended the Federal Food, Drug & Cosmetic Act, the final rule broadly defines “similar retail food establishments” such that many non-restaurants … Continue Reading

Sysco Agrees to Pay $19.4M to Settle California Enforcement Challenging the Company’s Food Safety Practices and Related Public Statements

The world’s largest food distributor, Sysco Corp., has entered into a settlement with the California Department of Public Health to resolve allegations that the company had engaged in unlawful food transportation and storage practices and had misrepresented its practices on the company’s website.  The Department alleged that the company held “perishable food and other food … Continue Reading
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