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Tag Archives: FDA

A “Surprise” Cosmetic Reform Bill Appears in Congress; Bipartisan Compromise Continues to Be Legislators’ Goal

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), U.S. Congress

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 of this post. The proposed legislation would amend… Continue Reading

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), U.S. Congress

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 a public meeting to solicit stakeholder feedback on… Continue Reading

Food Identity Disputes Continue to Impose High-Profile Pressure on FDA

Posted in Advertising, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

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. Similar disputes related to identity standards that don’t accommodate plant-based versions of… Continue Reading

Reading the Tea Leaves: Sales of Macadamia Nuts Could Be Going Up!

Posted in Advertising, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

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).

Reexamination of “Healthy” Continues with an FDA Public Meeting in March 2017

Posted in Advertising, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Product Class Actions

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 on what constitutes a “healthy” food and proper labeling of… Continue Reading

Cosmetics Reform Activity Begins in the 115th Congress

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress, Uncategorized

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 Modernization Amendments of 2015 (H.R.4075). Overall, the proposed legislation would amend… Continue Reading

FDA Finalizes Tobacco Product Intended Use Rules, Under a Risk of Rescission by Congress

Posted in Federal Regulations, Food & Drug Administration (FDA), Tobacco Products, U.S. Congress

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 a final rule to exclude products derived… Continue Reading

FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Product Liability

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, such as a serious illness or allergic… Continue Reading

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress

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 HELP Committee also heard from experts in… Continue Reading

Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings

Posted in Children's Products, Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety

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 six years (since a 2010 consumer alert about… Continue Reading

Moving on From “Natural,” FDA Seeks Comments on What It Means to Be a “Healthy” Food

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

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 (meaning it will not take action against) foods labeled with the term “healthy”… Continue Reading

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Uncategorized

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 it also completed work on a National Strategy for Modernizing the… Continue Reading

The Last Set of Major FSMA Regulations Are Done!

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Supply Chain Risk Management

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of FSMA (our posts on the… Continue Reading

OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA)

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 Health Affairs that FDA’s “current system of… Continue Reading

Senate Appropriations Bill Targets FDA Rulemaking Agenda

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress

The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed unanimously by the committee last month, the bill would give FDA marching orders to mandate the labeling of genetically engineered (GE) salmon, while putting… Continue Reading

FDA Finally Decides that “Evaporated Cane Juice” Is Misleading Consumers

Posted in Advertising, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

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 an ingredient in food labels may… Continue Reading

Just as the Comment Period for “Natural” Ends, FDA Announces Intent to Re-Examine What It Means to Be a “Healthy” Food

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

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?  Does natural connote “healthy” and is it… Continue Reading

“GMO” Labeling Food Fight: How Vermont’s Act 120 Is Pressuring An Entire Industry

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, State Regulations

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 “GMO” food labeling that preempts conflicting state or local laws, Vermont’s law will… Continue Reading

A Decade Later, Rules for the Sanitary Transportation of Food Finally Finalized by FDA

Posted in Distributors, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Retailer Product Safety, Supply Chain Risk Management

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 by rail or motor vehicle in the… Continue Reading

“Multi-Agency Interactive Tool” Available for Developers of Health Apps

Posted in Advertising, Federal Regulations, Federal Trade Commission (FTC), Food & Drug Administration (FDA)

It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies.  My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The Regulatory Robot that’s helping businesses identify the product safety rules that might apply to a new product.  This week, the Federal Trade Commission (FTC) — in conjunction with the Food… Continue Reading

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two and three will take place on March 9 and March 30 in Dallas, Texas and Davis, California, respectively. These meetings are an integral part… Continue Reading

FDA Places Ban on Import of GE Salmon

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, U.S. Congress

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 a hold on the importation of the… Continue Reading

“Just Mayo” Maker Convinces FDA That a Different Label Doesn’t Have to Include a Different Name

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

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 not mayonnaise as defined by federal regulations because it… Continue Reading

Confirmation of New FDA Head May Be Held Up By GE Salmon Labeling Issues

Posted in Food & Drug Administration (FDA), Food and Beverage

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.)  Dr. Califf appeared in front of the HELP Committee in mid-November; if… Continue Reading