Why Health Companies Need to Know How the FDA and FTC Enforce Regenerative Medicine Industry Violations

Avoid or mitigate potential FDA and FTC enforcement actions against stem cell and regenerative healthcare companies, including for false claims, by learning these legal keys

Why the FDA Won’t Approve Your Regenerative Medicine Practice

Regenerative medicine includes many treatments and products such as stem cell therapy, PRP, and gene therapy. An experienced stem cell and regenerative medicine lawyer can explain the FDA requirements.

New Farm Bill Opens Up Opportunities for the CBD Oil Market- If Companies Comply with the Legal and Regulatory Requirements

The Farm Bill of 2018 legalized CBD products that are hemp based for certain pharmaceutical uses. Food and dietary supplement possibilities may follow. Many different federal and state laws and [...]

Need-to-Know Laws and Regulations for Regenerative Medicine

Regenerative medicine includes products and treatments that can be regulated by the Food and Drug Administration. The laws are changing as this industry evolves.

Numerous CBD Business Opportunities where Sales are Legal

The legalization of many CBD oil products has opened the door to many new business opportunities. It is critical to review how each product is manufactured, classified, branded, marketed, and [...]

FTC Revised Online Endorsement Guidelines – Part Two

Makers of health care products and health care providers need to understand the FTC guidelines on soliciting endorsements, affiliate marketing, employee endorsements, and permissible testimonials [...]

FTC Revised Online Endorsement Guidelines

Answers to commonly asked questions about the new Federal Trade Commission (FTC) endorsement guidelines.

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

Signs that shape the landscape of the healthcare industry

Healthcare venture should always look out for unlicensed practice of medicine issues.

How to avoid FDA enforcement by not avoiding FDA in the first place – the top mistake companies typically make when marketing healthcare products

Starting a healthcare company without having prior FDA legal and regulatory review can place your company in serious jeopardy.

Hoping to Take Advantage of the New Medical Possibilities with Stem Cell Therapies? Be Informed.

The FDA has developed new guidelines that expand the safety requirements and manufacturing standards for stem cell treatments.

3 FDA Legal Traps When Marketing your Dietary Supplement Product

Learn how to avoid these FDA legal traps when marketing your dietary supplement product.

7 Legal Keys to Getting Your OTC Drug to Market

Wondering how to get your OTC drug to market? This FDA OTC drug primer tells you how.

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.

The Shocking Truth About FDA Dietary Supplement Labeling: 3 Things You Must Know

As they say in Game of Thrones, “Winter is Coming.” It’s a grim statement that reminds everyone that ahead is nothing but snow and ice. When you’re preparing to launch your dietary supplement [...]

Physicians & Healthcare Startups: Don’t Mess with Alphabet-Soup Lettered Government Agencies

Physicians and healthcare startups beware of FDA, FTC, and medical board liability: what you don’t know.

5 Mistakes in Dietary Supplement Labeling that Could Land you in FDA or FTC Enforcement Trouble

Many of our dietary supplement companies come to us with various mistaken assumptions with respect to labeling their dietary supplement products. Let’s talk about 5 key dietary supplement [...]

5 Ways Cosmetic Product Companies Can Comply with FDA Labeling Requirements & Help Avoid FDA Enforcement.

Cosmetic products do not require Food and Drug Administration (FDA) approval unless they have color additives or unless the qualify as a drug, medical device, or dietary supplements. There are [...]

How to Respond to an FDA Warning Letter about Dietary Supplements or Cosmetics

The United States Food and Drug Administration (FDA) regulates much more than food and drugs. It regulates dietary supplements, cosmetics, medical devices, tobacco products, animal food, [...]

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 [...]