News & Analysis as of

Dietary Supplements

Dietary Supplement & Cosmetics Legal Bulletin | December 2017

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

Sen. Hatch Introduces New Bill Regulating Cosmetic Safety - Sen. Orrin Hatch (R-Utah) has introduced legislation aiming to modernize cosmetics regulation, proposing amendments to the Federal Food, Drug and Cosmetic Act...more

Aligning a Product's Marketing, Regulatory and IP Plans

by Pepper Hamilton LLP on

Patent protection can be critical for health care products, including medical devices, prescription drugs, dietary supplements and software as a medical device (SaMD). Originally published in Law360 - September 8, 2017....more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Chris Mattei Announces Campaign for Connecticut Attorney General- Democrat Chris Mattei announced his candidacy for Connecticut AG in 2018, switching statewide races and forgoing a previously...more

Is It Time to Rethink Establishment Claims?

by Kelley Drye & Warren LLP on

The decision in Kwan v. Sanmedica International, 854 F.3d 1088 (9th Cir. 2017) in April, has occasioned a lot of discussion about the apparent demise of the establishment claim “standard” in California. What the Kwan decision...more

Food and Beverage News and Trends

by DLA Piper on

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. FDA publishes guidance for menu-labeling rule. On November 7, the FDA published...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

Food and Beverage News and Trends - November 2017

by DLA Piper on

FDA proposes revoking heart-health claim for soy protein. Citing "inconsistent findings" in research, the FDA announced October 30 that it is proposing to revoke its permission for companies to make a claim that soy...more

U.S. District Court Sanctions Weight-Loss Supplement Marketers for Violating Past Court Order

by Reed Smith on

A judge in the Northern District of Georgia has found a number of defendants, comprising a larger company named Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), in contempt for repeated violations of court orders prohibiting the...more

ITC Defers to FDA, Declining to Institute Section 337 Investigation

by Ropes & Gray LLP on

In what represents a departure from typical U.S. International Trade Commission (ITC) practice, the ITC on October 27, 2017 declined to institute a Section 337 investigation based on a complaint brought by Amarin Pharma, Inc....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

AD-ttorneys@law

by BakerHostetler on

On paper, FemaLife’s benefits sound great. The company made a series of boasts regarding its Super Flora Probiotic that positioned it as the answer to numerous problems: “If [your body] doesn’t receive the adequate nutrition...more

AGG Food and Drug Newsletter - October 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

You Can’t Change That: FDA Reiterates Risk of Delegating Responsibility in Quality Agreements

by Arnall Golden Gregory LLP on

In the span of three weeks, the Food and Drug Administration issued Warning Letters to two dietary supplement companies, in part, for relying, to their detriment, on quality agreements. We discussed another similar Warning...more

227k Consumers to Receive Refund Checks from Dietary Supplement Company Settlement

by Reed Smith on

Roughly 227,000 consumers will receive an average of $43 each in an effort by the Federal Trade Commission (FTC) to send refunds to purchasers of dietary supplement products sold by Health Formulas LLC. The $9.8 million...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

Cannabis Prop 65 Liability: Lessons Learned from the Dietary Supplement Industry

by Wilson Elser on

The cannabis industry appears to be next on the liability “hit list” under California’s notorious Proposition 65 statute. In June 2017, more than 700 Prop 65 notices were served on California cannabis businesses. Companies in...more

Case Dismissed in FTC v. Quincy Bioscience

by Kelley Drye & Warren LLP on

On Friday, a federal court in New York dismissed an FTC and New York Attorney General action against Quincy Bioscience, which sells the dietary supplement, Prevagen. Quincy bases claims for its product on research that...more

Natural Alternatives International, Inc. v. Allmax Nutrition, Inc. (S.D. Cal. 2017)

Last month, in Natural Alternatives International, Inc. v. Allmax Nutrition, Inc., District Judge Marilyn L. Huff of the U.S. District Court for the Southern District of California denied a Motion for Reconsideration filed by...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections - Delaware Attorney General Will Not Seek Re-election in 2018 - Delaware AG Matt Denn announced on his public Facebook page that he will not seek re-election in 2018. AG Denn, a Democrat, was elected to...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

Consumers beware: There’s lots of ugly in beauty products

The quest for beauty—whether skin deep or in the eye of the beholder—not only carries high costs. It also can be health risky. Jane Brody reminds us in the New York Times that due “to a lack of federal regulations, the...more

FDA and FTC Solicit Consumer Complaints About Dietary Supplement Marketing

by Pepper Hamilton LLP on

The Food and Drug Administration and the Federal Trade Commission have jointly requested that consumers report dietary supplements that “didn’t work as promised” or that are marketed with “unbelievable” claims. Consumers may...more

Dietary Supplement Patents Swallowed by the Products of Nature Exception

by Brinks Gilson & Lione on

It has been just over three years since the U.S. Supreme Court adopted a threshold test for determining patentable subject matter eligibility under §101 in Alice Corp. Pty. Ltd. v. CLS Bank Int’l. 134 S. Ct. 2347 (2014). This...more

Dietary Supplement & Cosmetics Legal Bulletin | July 2017

JAMA Study and Editorial Call for Improvements in Cosmetic Regulation and Surveillance - In response to a study analyzing adverse events for cosmetics and personal care products, the Journal of the American Medical...more

District Court Invalidates Dietary Supplement Patents On Motion To Dismiss

by Foley & Lardner LLP on

The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a...more

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