FDA & FTC Law

Over-the-counter (OTC) drugs must follow strict FDA labeling requirements to ensure consumer safety. Proper labels include active ingredients, uses, dosage instructions, warnings, and [...]

Navigating the legal boundaries for cosmetics in the U.S. requires understanding the distinct roles of the FDA and FTC. The FDA oversees product safety, labeling, and classification, ensuring [...]

FDA Warning Letters are formal notifications issued when the FDA finds significant regulatory violations in areas like labeling, marketing, or manufacturing practices. While a warning letter [...]

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) finely regulate the promotion compliance of medical devices—both in terms of the claims made and in the manner of [...]

In the last decade, the FDA’s Center for Devices and Radiological Health (CDRH) has implemented many new programs to help developers obtain authorization of medical devices

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

Many metaverse augmented reality, virtual reality, artificial intelligence, and other med-tech applications will need to meet FDA medical device requirements.

Integrative cardiology practitioners, doctors and non-physicians, need to review their working relationship for violations of state licensing laws, HIPAA, self-referral laws, and other legal [...]

The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.

The Food and Drug Administration issues a press release that said, even though the pandemic is severe, patients should receive the mRNA vaccines in two properly timed doses.

Johnson & Johnson’s adenovirus-based vaccine for preventing the transmission of COVID-19 is expected to be reviewed by the Food and Drug Administration in February 2021.

FDA granted emergency use authorization to Lucira Health Inc. for a COVID-19 self-testing kit. The EUA has numerous conditions that the manufacturer must meet.

FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers

The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration [...]

FDA might classify your cosmetics product as a new drug if you make disease claims for your cosmetics product. FDA also requires that you substantiate your claims and have safe ingredients

The FDA issues warning letters for numerous products including dietary supplements. FDA violations include findings that the supplement is a new drug, product adulteration, misbranding, and [...]

Jane’s Herbal Healthcare Startup is an ambitious collaboration with overseas physicians who use herbal medicine to treat certain diseases, based on some theory from another, indigenous system of [...]

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

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.

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 [...]

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

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

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

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

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

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

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

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

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 [...]

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 [...]

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 [...]

FDA is changing the playing field by withdrawing its earlier Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on [...]

BECAUSE TELEHEALTH AND TELEMEDICINE OFTEN INVOLVE PRACTICE ACROSS STATE LINES, HEALTHCARE PRACTITIONERS MUST UNDERSTAND THE STATE LAWS WHICH ALLOW PRACTICE IN SITUATIONS WHERE THE HEALTHCARE [...]

Healthcare providers who move beyond a brick-and-mortar physical practice often find themselves in a legal gray zone, wondering whether they are compliant, or even what rules might apply. This [...]

Does FDA deem your product to be a medical device, or is it just a consumer product that would not be regulated by FDA? Here are basic steps you can take to work through the puzzle.

The Federal Trade Commission (FTC) has slammed homeopathic drugs with a guidance document on substantiation. This is perhaps the biggest regulatory backlash against homeopathic medicine since [...]