Category Archives: Product Labeling & Marketing

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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

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 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  Many stakeholders and health advocates have argued that this conception of “healthy” may be outdated, and the agency hinted this week that it … Continue Reading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 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

San Francisco Backpedals on Ad Ban for Sugary Drinks, but Maintains Warnings Requirements

In June 2015, the San Francisco Board of Supervisors passed two sweeping ordinances concerning sugar-sweetened beverages designed to “inform the public of the presence of added sugars” and restrict certain advertising for these products.  The first ordinance requires warnings on certain advertisements for sugar-sweetened beverages to advise consumers about the “harmful health effects of consuming … 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 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

Not So Happy Meals? New York City Council Moves to Ban Free Toys Offered with Certain Food and Beverage Products

The New York City Council introduced a bill last week that would prohibit restaurants from offering free toys or other giveaways aimed at children in connection with certain meals and food and beverage products. The legislation would only permit restaurants to offer “incentive items” if the meal, food or beverage which with the item is … 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

FDA Proposes to Revamp Nutrition Labeling Requirements for Conventional Foods and Dietary Supplements

On March 3, 2014, FDA published two notices of proposed rulemaking detailing the agency’s proposed revisions to its nutrition labeling requirements. The proposed rules: (1) update the list of nutrients required or permitted to be declared, the Daily Reference Values and Reference Daily Intake values of several nutrients, and the format and appearance of the … Continue Reading

FDA Proposes Significant Changes to RACCs and Serving Size Requirements

In conjunction with the proposed changes to the nutrition labeling requirements, the FDA is separately issuing a proposed rule that would make significant changes to “reference amounts customarily consumed” (“RACCs”) for certain foods, and existing requirements governing the declaration of serving sizes for nutrition labeling purposes.  Existing FDA regulations prescribe the “RACC” for foods on a … Continue Reading

Is it a Beverage or Liquid Dietary Supplement? FDA Issues Final Guidance to Help Companies Tell the Important Difference

On January 14, 2014, FDA issued final guidance to help companies determine whether a product qualifies as a “dietary supplement” or “conventional food” as defined by the federal Food, Drug & Cosmetic Act (FD&C). While dietary supplements and conventional foods are both considered “foods” under the FD&C, there are important differences in the regulatory requirements … Continue Reading

FDA Announces Final Rule Banning BPA from Infant Formula Packaging

The Food and Drug Administration (“FDA”) announced last week the publication of a final rule banning bisphenol-A (“BPA”) from use in infant formula packaging – a decision made based on proof of industry abandonment rather than safety concerns. In July 2012, then-U.S. Representative Edward J. Markey filed a food additive petition seeking to amend the … Continue Reading

Industry Groups Challenge USDA Mandatory Country of Origin Rule on First Amendment and Other Grounds

The American Meat Institute (AMI), along with seven other meat and livestock organizations representing the United States, Canada, and Mexico, filed an action this week challenging USDA’s recent mandatory country of origin rule. Issued by the Agricultural Marketing Service (AMS) on May 24, the final rule would revise existing regulations to require covered products to … Continue Reading

TTB Promulgates Final Rule Establishing Standard of Identity for Pisco as Type of Brandy

The Alcohol and Tobacco Tax and Trade Bureau (TTB) released today its final rule that amends TTB standard of identity regulations for distilled spirits to expressly list Pisco as a type of brandy. Under the Federal Alcohol Administration Act, TTB prescribes requirements for the packaging, marking, branding, labeling, and quality of alcoholic beverages. Pursuant to … Continue Reading

Handy Health Tracking Mobile App…Or Regulated Medical Device?

The use of mobile apps for health purposes has created new questions for users, developers, and regulators regarding the balance between convenience, expanded health care, and public safety. The line between apps that are useful tools for accessing health information and those that are considered medical devices can be unclear but is very important for … Continue Reading

DHHS and FDA Officials Respond to Medical Device Mobile Application Regulatory Concerns on Final Day of Hearings

The House Subcommittee on Oversight and Investigations concluded a three-day series of hearings regarding medical device mobile applications (“MMAs”) on Thursday morning. Our posts regarding the first two hearings are here and here. The focus of day three was to hear testimony from key FDA and DHHS officials who have responsibilities relating to MMAs and … Continue Reading

Day 2 of Medical Device Mobile App Hearings Focuses on Patient Benefits

The Health Subcommittee of the House of Representatives Energy and Commerce Committee held a second day of hearings regarding medical device mobile applications (“MMAs”) on Wednesday. Our post regarding the first day of hearings can be found here. The focus of day two was “Health Information Technologies: How Innovation Benefits Patients.” The subcommittee heard from … Continue Reading

Ninth Circuit Rejects First Amendment Defense In Wire Fraud Case Regarding Drug Misbranding

This is a follow-up to our post late last year on the Second Circuit decision in US v. Caronia, which overturned a defendant’s off-label marketing conviction on First Amendment grounds (see our December 10, 2012 post, “Second Circuit Overturns Off-Label Marketing Conviction On First Amendment Grounds”). In United States v. Harkonen, the Ninth Circuit rejected … Continue Reading

IOM Report on Counterfeit Drugs Released

On February 13, 2013, the Institute of Medicine of the National Academies (IOM) released its report Countering the Problem of Falsified and Substandard Drugs. The report identifies causes and recommends strategies to address the problem of substandard and falsified drugs. The IOM first distinguishes public health concerns of falsified and substandard drugs from the intellectual … Continue Reading

Heightened FDA Activity Related to OTC Drugs Expected in 2013

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:  Proposed Monograph Modifications  Amending the … Continue Reading
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