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The United States Food and Drug Administration Advertising

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -

Food Litigation Trends: New and Undefined Label Claims in 2017

by Pepper Hamilton LLP on

Part 1: Current Trends and Ingredient Claims - Class-action lawsuits involving the false advertising of food products continue to be one of the most active areas in class litigation. Originally published in Update...more

Soy Vey! FDA May Revoke Soy’s Heart Health-Claim

by Reed Smith on

The FDA has called into question its health claim finding a link between consumption of soy protein and reduced risk of heart disease. Since 1999, the FDA has allowed manufacturers and advertisers to label soy products with...more

AD-ttorneys@law

by BakerHostetler on

Once completely obscure, fidget spinners are now a thing. Meaning that their existence, if not their actual purpose, has become known to you. Dubbed by The New York Times “a Hula Hoop for Generation Z,” the fidget spinner...more

FDA Publishes Supplemental Guidance on Menu Labeling for Chain Restaurants

by McDermott Will & Emery on

On November 7, the US Food and Drug Administration (FDA) published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain...more

10 Marketing Law Takeaways From ANA/BAA 2017

We just got back from the Association of National Advertising (ANA) and Brand Activation Association (BAA) Marketing Law Conference in Chicago, held earlier this week. With hundreds in attendance, and dozens of speakers...more

Adverse Event Reports for Food, Supplements and Cosmetics Are Now Publicly Available: What Manufacturers Need to Know

by Pepper Hamilton LLP on

Enhancing transparency has been one of the FDA’s top priorities for nearly a decade. In late 2016, the agency continued to advance this goal by publishing data relating to food, cosmetics and dietary supplements from its...more

Love Is Not An Ingredient

by Fox Rothschild LLP on

Last month, the Food & Drug Administration (“FDA”) sent a lengthy warning letter to Nashoba Brook Bakery, a bakery based in Massachusetts, identifying a number of alleged violations of food regulations and labeling...more

Bad For Your Health: Lawsuit Advertising Implications And Solutions

by Shook, Hardy & Bacon L.L.P. on

Shook, Hardy & Bacon Partner Cary Silverman has authored a report for the U.S. Chamber Institute for Legal Reform examining the effects of advertising soliciting plaintiffs for lawsuits targeting prescription drugs and...more

Food & Beverage Litigation Update | October 2017 #4

by Shook, Hardy & Bacon L.L.P. on

Furans in Baby Food May Pose Health Risk, EFSA Reports - The European Food Safety Authority (EFSA) has issued an assessment of the risks of furans and related compounds 2- and 3-methylfurans, concluding that they pose a...more

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

by Shook, Hardy & Bacon L.L.P. on

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Food & Beverage Litigation Update | October 2017 #3

by Shook, Hardy & Bacon L.L.P. on

FDA Warns Snyder’s-Lance About Iron Content Labels - The U.S. Food and Drug Administration (FDA) has sent a warning letter to Snyder’s-Lance, Inc. about the iron content of its Lance Toast Chee Crackers. The letter...more

Food For Thought: Liability-Only Class Certification Denied For Claims That “No Sugar Added” Juice Labels Misled Consumers Into...

by Carlton Fields on

Plaintiff’s putative class action alleged that defendant Mott’s violated FDA regulations and California’s Sherman Law and Unfair Competition Law when it labeled and sold its 100 percent apple juice with the label “No Sugar...more

Regulation Of Dietary Supplements

by Fox Rothschild LLP on

The U.S. Food and Drug Administration (“FDA”) regulates dietary supplements as food, not as drugs. In general, dietary supplements are taken orally and contain a dietary ingredient such as a vitamin, mineral, amino acid,...more

FDA Scolds Company Claiming to Bake with Love

by Faegre Baker Daniels on

Where’s the love? Apparently, not at the FDA. On September 22 the FDA issued Warning Letter CMS# 532236 to Nashoba Brook Bakery, of Concord, Mass. Among several infractions cited in the letter was one for the misbranding...more

Love Is a Many-Spendored Thing, but It’s Not an Ingredient

by Kelley Drye & Warren LLP on

The Food and Drug Administration has made the news lately for disapproving a Massachusetts bakery’s inclusion of “love” among the listed ingredients in its granola products. Nashoba Brook Bakery produces breads and granolas...more

Food & Beverage Litigation Update | October 2017

OIG Report Suggests Improvements to FSMA Enforcement - A report from the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services has concluded that the Food and Drug Administration (FDA)...more

Food & Beverage Litigation Update | September 2017 #3

FDA Announces Final FSMA Produce Safety Rule - The U.S. Food and Drug Administration (FDA) has announced that the produce safety rule of the Food Safety and Modernization Act of 2010 (FSMA) is now final, establishing...more

AD-ttorneys@law

by BakerHostetler on

Abbott Nutrition did something unique. It added a new ingredient to its Similac Pro-Advance and Pro-Sensitive infant formulas that, until now, had only been available in human breast milk: 2’-fucosyllactose human milk...more

Coming soon from FDA? Streamlined safety information in prescription drug television ads

by DLA Piper on

Most people are by now familiar with prescription drug TV ads that provide lengthy (and often confusing) laundry-list descriptions of numerous potential safety risks (seemingly regardless of the severity or likelihood of the...more

Dietary Supplement & Cosmetics Legal Bulletin | August 2017

"Miracle Gel" Not a Salon Gel Manicure, Ad Board Says - In an appeal from a ruling by the National Advertising Division (NAD), the National Advertising Review Board (NARB) upheld a recommendation that Coty discontinue...more

Too Much or Too Little: FDA Requests Comments on New Strategy Regarding Risk Information in DTC Ads

by Hogan Lovells on

On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

by Hogan Lovells on

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills...more

Blog: FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion

by Cooley LLP on

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding...more

Advertising Law - June 2017 #3

FTC Jumps on Trampoline Marketing - The Federal Trade Commission (FTC) bounced purportedly misleading trampoline marketing claims in a new administrative consent order. Son “Sonny” Le and his brother Bao “Bobby” Le...more

FDA Warns Against Products Claiming to Cure Cancer

by Fox Rothschild LLP on

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so...more

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