Food & Drug Administration (FDA)

Happy New Year! And now on to your regular Consumer Product Matters programming…

As we predicted earlier this year, Congress is making moves toward enacting cosmetics reform legislation in the near future. In late October 2017, Senator Orrin Hatch (R-UT) introduced S. 2003, the “FDA Cosmetic Safety and Modernization Act,” which we will refer to as the “Hatch bill” for purposes…

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held…

As we reported on previously (see here and here), FDA recently tussled with the manufacturer of an innovative vegan condiment called “Just Mayo” based on the existence of a Federal standard of identity for mayonnaise that requires the food product to incorporate eggs.

On July 24, 2017, the Food and Drug Administration announced that it had responded to a November 2015 petition from Royal Hawaiian Macadamia Nut, Inc. for a new qualified health claim characterizing the relationship between macadamia nut consumption and a reduced risk of coronary heart disease (CHD).

As we’ve previously reported, FDA has signaled its interest in reviewing the scope and meaning of the nutrient content claim “healthy,” in part as result of a dispute with KIND LLC about label claims for its KIND Bar products. Then last fall FDA released a new guidance document…

As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic…

As we’ve previously written about, 2016 represented a regulatory sea change for manufacturers, distributors, and retailers of e-cigarettes and other electronic nicotine delivery systems (ENDS), who became subject to FDA oversight and requirements under the May 2016 Deeming Rule for tobacco products. In Monday’s Federal Register, FDA issued…

On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements. Adverse events can be any negative reaction to a product,…

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014). More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions Committee received testimony from Senators Feinstein and Collins in support of this bipartisan legislation. The…

Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over 400 other adverse event reports over the past…

As it signaled it would be doing earlier this year, FDA has initiated a public process to redefine the implied nutrient content claim “healthy” when it is used on food labels and labeling. In addition, while the process is underway, the Agency intends to exercise enforcement discretion for…

After launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and…

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other interested parties, including dozens of plaintiffs in lawsuits stemming from battery explosions and other injuries. Newly enacted…

As a parting act before its seven-week recess, the House last Thursday passed by a vote of 306-117 Senator Pat Roberts’s (R-KS) legislation (S.764) requiring the labeling of genetically engineered foods. Already approved by the Senate last week, the bill is now expected to be signed into law…

Four months after the Senate defeated a GE labeling bill (S.2609) introduced by Agriculture Committee Chairman Pat Roberts (R-KS), the upper chamber Thursday night passed, 63-30, a compromise measure (S. 764) that Roberts co-wrote with Senator Debbie Stabenow (D-MI), the Ag Committee’s Ranking Member.

Continuing a discussion that began in 2014, on June 10, 2016 FDA hosted a public meeting on the potential development of a user fee program for OTC (over-the-counter, or nonprescription) drug products marketed pursuant to the Agency’s monograph system. Agency leader Dr. Janet Woodcock wrote last week in…

Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized FDA guidance on use of the term “evaporated cane juice” (“ECJ”)…

As any company making and selling food products knows, late last year FDA requested information and comments regarding the appropriate use of the term “natural” for food – the Agency asked what types of processing make that claim misleading, or does the food have to be completely unprocessed?…

On July 1, 2016, Vermont’s Act 120 will require food manufacturers to indicate in the labeling of all products regulated by FDA when the food has been produced with the use of genetic engineering (GE). Unless Congress acts with unusual swiftness to pass federal legislation regarding GE or…

Last week, FDA finalized new food safety regulations seeking to ensure the sanitary transport of human and animal food, as required under the Food Safety Modernization Act (FSMA). The final Sanitary Transportation of Human and Animal Food Rule will affect shippers, loaders, carriers, and receivers of food transported…

In the wake of the Senate’s defeat of legislation that would have preempted state-mandated GE ingredient labeling on food products, a new trend is emerging, as one food manufacturer after another announces that they will voluntarily label bioengineered ingredients contained in their national food product lines. The chain…

Reversing course from the end of 2015, FDA recently announced an import ban on genetically engineered (GE) salmon until such a time as comprehensive labeling guidelines are introduced. Despite FDA’s approval of GE salmon in November 2015, the agency appears to have bowed to congressional pressure and placed…

Back in September we blogged about the Warning Letter that FDA issued to Hampton Creek Foods, Inc. for its vegan food dressing and sandwich spread, “Just Mayo” and a similar product, “Just Mayo Sriracha.” In addition to several other interesting labeling violations, FDA noted that “Just Mayo” was…

On Tuesday, the Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously approved the President’s nomination of Dr. Robert Califf as the next commissioner of food and drugs. (Senator Bernie Sanders, I-VT, who would have voted against the nomination, was not present at the January 12th committee session.)…

The 2016 Omnibus Spending Bill recently passed by both houses of Congress ushers in important developments in the food safety, labeling, and nutrition spaces. Following House and Senate votes December 18, it now goes to President Obama for his signature.

Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for use as human food – AquaBounty Technologies’s AquAdvantage Salmon, a transgenic Atlantic…

On November 12, 2015, FDA is scheduled to publish a notice in the Federal Register announcing a request for public comments on the use of the term “natural” in food labeling. As the Agency points out, it has been under pressure in recent years from many stakeholders to…

A bluntly labeled section of the Code of Federal Regulations – “Mayonnaise” – provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those ingredients. The goals of this and other standardized food definitions are to prevent economic fraud on…

On Mintz Levin’s Health Law and Policy Matters blog, our colleague Joanne Hawana discussed the August 7 Warning Letter sent by FDA to the drug company Duchesnay, Inc., after Kim Kardashian praised the company’s morning sickness pill Diclegis in an Instagram post.

Today the Safe and Accurate Food Labeling Act of 2015 passed the House, in a vote of 275 to 150 (more information here). Still a hot-button issue, opposition to the Act is emotionally charged, with those opposed to the bill calling it the “DARK” Act (Denying Americans the…

The proposed Federal regulation of GMOs is proceeding. Following the White House’s recent action on GMOs, Representative Pompeo’s “Safe and Accurate Food Labeling Act” (H.R. 1599) was passed by the House Agriculture Committee on July 14.

The “toxic trio” is a foreboding name some associate with common and seemingly innocuous manicures and pedicures. Salon workers suffer higher-than-average rates of birth defects, miscarriages, cancers, and skin afflictions stemming from their daily use of nail products, many of which contain potentially harmful chemicals. A New York…

Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation.

Acting to finalize a tentative decision from 2013, FDA announced on June 15, 2015 that it was issuing a declaratory order that will require manufacturers to remove partially hydrogenated oils (PHOs) from processed foods over the next three years. PHOs in ready-to-eat foods like baked goods, snack foods,…

As many readers of this blog know, the start of 2011 saw the enactment of a massive bill aimed at overhauling the nation’s food safety system to become more preventive instead of reactive to safety problems and illness outbreaks. Among the numerous significant new regulations, requirements, and programs…

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food, Drug, and Cosmetic Act (the Act) and may run afoul of the U.S. Food…

Last week, Sen. Barbara Boxer of California, Richard Blumenthal of Connecticut, and Rep. Peter DeFazio (D-Ore)-joined by chef-lebrity Tom Colicchio-announced the reintroduction of The Genetically Engineered Food Right-to-Know Act, a federal bill that would mandate the labeling of foods or beverages containing genetically-modified organisms (GMOs). The bill is…

This has been a big year for GMO legislation. In 2014 alone, 25 states have proposed 67 pieces of legislation aimed either at the labeling of products containing GMOs or at the ban of GMO-containing crops. While this space has strived to keep you up-to-date with the latest…

As we’ve explored in past posts, Congress is currently considering a bill that aims to harmonize the patchwork of state efforts at regulating GMO labeling by placing such regulation firmly within FDA’s jurisdiction. Dubbed the Safe and Accurate Food Labeling Act (H.R. 4432), this bill would give FDA…

As we’ve explored in past posts, mandatory GMO-labeling legislation has, at best, a spotty track record among state legislatures. Nevertheless, the GMO issue continues to draw the public’s attention, and it is becoming clear that the “Non-GMO” label now appeals to at least certain segments of the consumer…

Bids to require mandatory labeling of foods containing genetically modified organisms (GMO) were voted down in Colorado and Oregon on Tuesday. Colorado voters rejected Proposition 105, with nearly 70% of voters saying no; while Oregon voters rejected Measure 92, with only 50.9% against the initiative, and 49.1% in…

On October 20, 2014, FDA reached a settlement with the Center for Food Safety (“CFS”) in litigation pending in the U.S. District Court for the District of Columbia. This litigation is related to FDA’s rule for food additives that are “generally recognized as safe” (“GRAS”). In 1997, FDA…

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many reported incidents of food-borne illness during the 2000s.

This space has thoroughly explored the various forms of civil liability food companies face for the mislabeling and/or deceptive marketing of their products. Last week, a set of landmark convictions in a criminal food-safety prosecution potentially signal increased criminal liability for food companies when matters of public health…

On August 26, 2014, the FDA issued draft guidance to address “controlled correspondence,” which is the correspondence that generic drug manufacturers submit to the FDA to request information and to clarify issues related to generic drug development, and the FDA’s procedure for responding to such correspondence. The FDA…

Throughout the year, this space has periodically re-visited the topic of regulating the manufacture and labeling of foods with genetically modified ingredients (GMOs) at the state and federal level. This week, a lawsuit out of Kauai, Hawaii shed light on the fate of these regulations at the county…

Last week, a California federal judge revived a putative class action accusing Amy’s Kitchen Inc. of misleading customers by labeling sugar as “evaporated cane juice” on its products. In a finding that puts the case on hold until the FDA weighs in, Judge Illston found that a decision…

Yesterday the Supreme Court ruled, 8-0, that Pom Wonderful LLC could pursue mislabeling claims under the federal Lanham Act against the Coca-Cola Company, even though the label at issue complied with FDA labeling regulations. The decision reversed the Ninth Circuit’s 2012 ruling that the FDA’s “comprehensive regulation” of…

Not to be left behind and not dependent on any other state action (Connecticut and Maine notwithstanding), a bill has been introduced (SB 1381) on February 21, 2014 that requires any food, with certain exceptions (more on that later), offered for retail sale in California to be labeled…

“As Maine goes, so goes the nation” was a phrase that described Maine’s reputation as a bellwether state for presidential elections from 1832 through approximately 1936.

California’s District Courts have, of late, become the go-to jurisdictions for plaintiffs bringing ‘natural’ labeling lawsuits against national food manufacturers. This is due, in large part, to California’s consumer-friendly Unfair Competition Law, False Advertising Law, and Consumer’s Legal Remedies Act. California District Courts may be sending a different…

“When I use a word,’ Humpty Dumpty said in rather a scornful tone, ‘it means just what I choose it to mean — neither more nor less.’”

Proposed legislation has been introduced by 3 members of the House, including Rep. Frank Pallone (D-NJ), senior Democrat on the House Energy & Commerce Health Subcommittee, which would direct the Secretary of Health & Human Services (HHS) to create a single, standard front-of-package labeling system for all food…

Would “reasonable consumers” have regarded Paul Cezanne as highly had he painted numerous versions of still life with froot?

A question before district courts these days seems to be whether 100% natural molasses move any slower than the FDA. In July, the Food Court in the Northern District of California asked FDA to opine on the proper use and application of “whether and under what circumstances food…

On August 5, 2013 the FDA issued its final rule on the voluntary labeling of food gluten-free. This is good news for both consumers and manufacturers.

Manufacturers are removing “natural” statements from their labels, both as part of lawsuit settlements and as an alternate marketing strategy. PepsiCo has agreed to remove the phrase from its Naked juices after a lawsuit was filed against it in California, stating that it will wait for more detailed…

In what may be an indication of things to come, the Food Court (US District Court Northern District of California) has decided to ask FDA for guidance on what it wants on food labels. The Food Court directly addressed the labeling of foods containing GMOs as “natural” in…

Some are concerned that the potential health consequence of the use of genetically modified organisms in food is unknown because of the lack of long-term testing proving that it is safe. Fearful consumers imagine “Franken foods,” conjuring up images of over-sized ears of corn that shuffle about the…

When should a court decide a case that has issues involving an area that Congress has already weighed in on? In the case of cosmetics and FDA, when a lawsuit requires a court to decide an issue committed to FDA’s expertise without a clear indication of how FDA…

Are you for or against GMOs? Do you think the government should get involved? Whether for or against legislation requiring labeling showing any Genetically Modified Organism contained in your food, the fact that the two sides are diametrically opposed on interpretation of critical aspects will ensure litigation. In…

It’s 2 o’clock in the afternoon, you need a snack – maybe a granola bar, but which one? Does the package that boasts it is “100% Natural” win out over the one that is only “All Natural”? Would you even consider one that is merely “Natural”? Well, don’t…