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  • Home
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    • Healthcare Law
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      • Dispute Resolution
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      • General Corporate Law
      • HIPAA
      • Licensing Agreements & IP Protection
      • Leases & Real Estate
      • Liability & Risk Management
      • M&A (Acquisitions & Sales of Healthcare Businesses)
      • Management Services Organizations (MSO) Issues
      • Technology Agreements
      • Telemedicine
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      • Biotechnology Issues
      • Cosmetics Claims
      • Dietary Supplements Claims & Labeling
      • FDA Warning Letters
      • FTC Compliance
      • Medical Device & Mobile Medical App Issues
      • Off-Label Use
      • OTC & Homeopathic Drug Companies
    • Firm Experience
  • Who We Serve
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    • ANTI-AGING & FUNCTIONAL MEDICINE PRACTICES
    • BEHAVIORAL & MENTAL HEALTHCARE PROVIDERS AND LIFE COACHES
    • BIOTECHNOLOGY & LIFE SCIENCES COMPANIES
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    • CHIROPRACTORS
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    • DIETARY SUPPLEMENT & NUTRACEUTICAL COMPANIES
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Federal District Court Orders New York Company to Stop Distributing Adulterated and Misbranded Dietary Supplements
By Staff
In Dietary Supplements (Claims and Labeling)
Posted May 1, 2021

Federal District Court Orders New York Company to Stop Distributing Adulterated and Misbranded Dietary Supplements

FDA enforcement warning letters sent to manufacturers of CBD based dietary supplements due to non-permissible misbranding and adulteration claims

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FTC Sends 45 Warning Letters to Companies Making False Claims that their Products and Treatments Can Prevent or Cure COVID-19
By Staff
In Healthcare Law
Posted June 14, 2020

FTC Sends 45 Warning Letters to Companies Making False Claims that their Products and Treatments Can Prevent or Cure COVID-19

The Federal Trade Commission sent 45 more warning letters to businesses for falsely claiming their supplements, herbs, and other products and therapies could prevent to treat COVID-19

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Can Paying Attention to These Common FDA Mistakes Save Your Healthcare Company from a Plaintiffs’ Lawsuit?
By Michael H Cohen
In FDA & FTC Law
Posted August 1, 2019

Can Paying Attention to These Common FDA Mistakes Save Your Healthcare Company from a Plaintiffs’ Lawsuit?

Common FDA mistakes that cause healthcare companies to get sued

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10 Legal Tips to Stop FDA from Classifying Your Dietary Supplement as a Drug
By Michael H Cohen
In FDA & FTC Law
Posted December 15, 2018

10 Legal Tips to Stop FDA from Classifying Your Dietary Supplement as a Drug

Your dietary supplement products could be regulated as a new drug by FDA, unless you pay attention to these regulatory fundamentals.

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FDA Dietary Supplement Labeling Requirements: Comply or Die
By Michael H Cohen
In Dietary Supplements (Claims and Labeling), FDA & FTC Law
Posted May 1, 2018

FDA Dietary Supplement Labeling Requirements: Comply or Die

FDA labeling is one of the most important regulatory requirements for dietary supplements in that it provides the consumer the necessary information on the product. Indeed, ensuring that all [...]

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Animal dietary supplement manufacturers and distributors beware of FDA warning letters
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By Michael H Cohen
In Dietary Supplements (Claims and Labeling), FDA & FTC Law, Healthcare Law
Posted April 5, 2017

Animal dietary supplement manufacturers and distributors beware of FDA warning letters

Animal dietary supplement manufacturers and distributors can run afoul of FDA prohibitions against “drug” claims and receive an FDA warning letter, unless they understand how FDA regulates animal [...]

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Dietary supplement legal review could save your company
0
By Michael H Cohen
In Dietary Supplements (Claims and Labeling), FDA & FTC Law
Posted March 22, 2016

Dietary supplement legal review could save your company

If you want to sell healthcare products online, the legal hurdles can be steep. 

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FTC Slams Fat Burning, Calorie-Blocking and Body Slimming Marketing
0
By Michael H Cohen
In FDA & FTC Law, General
Posted October 22, 2015

FTC Slams Fat Burning, Calorie-Blocking and Body Slimming Marketing

Would you like to lose weight without diet or exercise, by a magical fat-burning, calorie-busting, body-slimming dietary supplement or cream? Here's how.......

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Dietary Supplements – Strategies to Reduce FDA Risk
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By Michael H Cohen
In Dietary Supplements (Claims and Labeling), FDA & FTC Law
Posted July 11, 2015

Dietary Supplements – Strategies to Reduce FDA Risk

Because marketing and distributing dietary supplements carries FDA risk, we offer sample strategies to reduce FDA risk when selling dietary supplements.

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Herbal Supplements Investigated for Misbranding and Adulteration
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By Michael H Cohen
In Dietary Supplements (Claims and Labeling), FDA & FTC Law, Healthcare Law
Posted March 16, 2015

Herbal Supplements Investigated for Misbranding and Adulteration

New York's Attorney General initiated the investigation against major retailers of herbal supplements, based on DNA testing of plant materials suggesting contaminants, and mislabeling; was the [...]

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9 Keys to Managing Risk of FTC enforcement (especially with anti-aging and weight loss claims)
0
By Michael H Cohen
In FDA & FTC Law
Posted March 1, 2015

9 Keys to Managing Risk of FTC enforcement (especially with anti-aging and weight loss claims)

If you market your healthcare products, FTC enforcement can stop your sales in their tracks. All it takes is a search - yes, good old keywords - and you're in line for significant penalties for [...]

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FDA is hands-off Low Risk General Wellness Products
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By Michael H Cohen
In FDA & FTC Law
Posted February 15, 2015

FDA is hands-off Low Risk General Wellness Products

FDA has published a Draft Guidance on Low Risk Devices which suggest a hands-off FDA approach to consumer products that are intended for general wellness use, and, present low safety risk

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Energy drinks raise a monster of FDA and state legal concerns
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By Michael H Cohen
In Business Law, FDA & FTC Law, Law Firm News
Posted January 8, 2015

Energy drinks raise a monster of FDA and state legal concerns

Energy drinks, like dietary supplements promising energy boosts, weight loss, and other benefits, raise significant FDA legal challenges; how can manufacturers avoid the barrage of FDA and state [...]

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