News & Analysis as of

Weight-Loss Products Food and Drug Administration (FDA)

American Conference Institute (ACI)

[Virtual Conference] Inaugural Summit on GLP-1 Law & Policy - July 24th, 8:15 am - 5:15 pm ET

The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more

Troutman Pepper Locke

Connecticut AG Pursuing Companies for Allegedly Selling Unlawful Weight Loss Drugs

Troutman Pepper Locke on

Connecticut Attorney General (AG) William Tong has taken legal action against two online distributors, Triggered Brand and Made In China, for allegedly selling research-grade GLP-1 weight loss drugs directly to Connecticut...more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

Kelley Drye & Warren LLP

Two Class Actions Take a ShOt at Substantiation for Lemme’s GLP-1 Daily Supplement

Two new class action complaints, both captioned Robins v. Lemme Inc., were filed in in California Superior Court and the Southern District of New York on February 19 and March 9, respectively....more

Hendershot Cowart P.C.

Novo Nordisk Urges FDA to Ban Compounded Semaglutide – What Weight-Loss Clinic Owners Need to Know

Hendershot Cowart P.C. on

Novo Nordisk, the manufacturer of Ozempic and Wegovy, has petitioned the Food and Drug Administration (FDA) to add semaglutide, the active ingredient in Wegovy and Ozempic, to the "Demonstrable Difficulties for Compounding"...more

Fuerst Ittleman David & Joseph

Compounded GLP-1 Drugs: is the Party Over? These Are the Legal and Regulatory Issues for Game Changing Weight Loss Products and...

Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more

Hissey, Mulderig & Friend, PLLC

Ozempic Weight Loss Users at Risk of Gastroparesis and Other Stomach Problems, New Study Reveals

A recent study published by the Journal of the American Medical Association (JAMA) found that patients taking the drugs Ozempic (semaglutide) and Wegovy (liraglutide) for weight loss were more than three-times more likely to...more

Hissey, Mulderig & Friend, PLLC

Ozempic, Other Diabetes-Weight Loss Drugs Linked to 162 Deaths, According to FDA Data

Ozempic and other diabetes-weight loss drugs have been linked to at least 162 deaths and 10,000 cases involving “serious” injuries since 2018, according to data from the U.S. Food and Drug Administration (FDA)....more

McDermott Will & Emery

Weight Loss Drug Shortages Will End Soon

On August 8, 2024, the US Food and Drug Administration (FDA) partially revised the availability of certain glucagon-like peptide 1 (GLP-1) medications on the FDA’s shortage list. In particular, FDA updated the availability of...more

Hissey, Mulderig & Friend, PLLC

Mounjaro, Ozempic Lawsuits Allege Weight Loss, Diabetes Drugs Linked to Serious Gastrointestinal Problems

Lawsuits filed against the manufacturers of Ozempic, Mounjaro, and other weight control and diabetes drugs have alleged that these medications can cause serious gastrointestinal side effects, including gastroparesis, stomach...more

Proskauer - Minding Your Business

Ozempic Gains Popularity, Its Maker Loses First Legal Fight

With Hollywood celebrities speaking out both in favor of and against the use of drugs like Ozempic and Wegovy for weight loss, it was only a matter of time before demand outpaced supply. Although most might believe that...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin - December 2022

LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...more

Searcy Denney Scarola Barnhart & Shipley

Did Patients Trade Weight Loss Concerns for Cancer Concerns? - BELVIQ

Is BELVIQ adding to patient cancer risks? In February of 2020, an announcement was made that the weight loss drug lorcaserin (sold under brand names BELVIQ and BELVIQ XR) would be voluntarily withdrawn from the market in...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin l November 2018

LEGISLATION, REGULATIONS & STANDARDS - Personal Care Products Legislation Introduced in Congress - Rep. Janice Schakowsky (D-Ill.) has introduced the Safe Cosmetics and Personal Care Products Act of 2018, which would...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | October 2018

LEGISLATION, REGULATIONS & STANDARDS - California Passes Professional-Cosmetics, Animal-Testing Laws - California Governor Jerry Brown has signed a law that will bring labeling for professional cosmetics in line with...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

Foley Hoag LLP - Making Your Mark

I May Not Be Able To Pronounce Acai But I Know It Doesn’t Burn Fat Cells: 5 Recent Over-the-Top Weight Loss Advertising Claims And...

Some say “ah-sigh;” I say “ah-kai;” but apparently the proper pronunciation of “acai” — the so-called super berry — is actually “ah-sigh-ee.” Who knew? Acai berries are native to the Amazon rainforest and have been hailed...more

Searcy Denney Scarola Barnhart & Shipley

Weight Loss Supplement Alli Recalled Nationwide

Just to be safe, drugmaker GlaxoSmithKline (GSK) Consumer healthcare will remove all of its weight loss drug alli from stores shelves in the U.S. and Puerto Rico due to fear of contamination. There have been at least 20...more

Morgan Lewis

FTC Cracks Down on False Advertising in Dietary Supplements

Morgan Lewis on

Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising. Recent Federal Trade Commission (FTC) enforcement activities—including a...more

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