FDA & FTC Law

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 [...]

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 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Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, and issuing its new draft Guidance on [...]

PRIVACY, CONFIDENTIALITY, AND SECURITY ISSUES ARISE WHEN PRACTICING TELEHEALTH OR TELEMEDICINE JUST AS THEY DO IN A BRICK-AND-MORTAR PRACTICE. IT’S ESPECIALLY IMPORTANT TO UNDERSTAND THESE [...]

HOW DO HEALTHCARE PRACTITIONERS HANDLE STANDARD OF CARE ISSUES WHEN DIAGNOSING AND TREATING FROM A DISTANCE?

THE LAW HANDLES TELEMEDICINE PRESCRIPTION DIFFERENTLY THAN DIAGNOSING AND TREATING REMOTELY. HOW CAN YOU BEST COMPLY? PRESCRIBING IS DIFFERENT THAN OTHER TREATMENT

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 [...]

While recent legal developments have loosened legal strictures around truthful, non-misleading, off-label promotion of drugs, there are legal limits to an off-label promotion strategy. Here [...]

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 [...]

If you’re a dietary supplement manufacturer or distributor, know that FDA and FTC now encourage the public to report dietary supplement labeling violations.

Many healthcare companies, practitioners, and patients, think that they can get away with bringing unapproved drugs into the U.S. and that the FDA Personal Importation Policy will cover [...]

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 [...]

Substance abuse treatment centers must steer carefully when sending patients for labs. Self-referral, anti-kickback, and fee-splitting rules can create legal enforcement issues and must be [...]

If you have a medi-spa where the physician is never there but serves as “Medical Director,” think again. A lot of people misunderstand the concept of “medical director.” A medical director is [...]

Is it fee-splitting to hire another medical doctor, chiropractor, acupuncturist, or other health care practitioner in your office and give them a “cut” of patient revenues? Fee-splitting, [...]

Is it illegal for audiologists to dispense PSAPs? More broadly – are disruptive technologies also exploding healthcare professionals’ ability to prescribe or recommend to their patients? I [...]

WHEN ESTABLISHING YOUR FUNCTIONAL MEDICINE PRACTICE, YOU’LL BE WADING INTO CLINICAL WATERS THAT ARE OFTEN NAVIGATED BY MANY MEDICAL COLLEAGUES, YET NOT NECESSARILY ADOPTED WITHIN THE MAINSTREAM [...]

Avoid these common FDA mistakes marketing health products: communicating with FDA without legal counsel, making disease claims, misunderstanding the rules.

Our guest post this month is from Siegfried Othmer, Chief Scientist of the EEG Institute and President of the Brian Othmer Foundation, challenging this year’s FTC “brain training” enforcement.

For an OTC drug marketing legal checklist, 5 legal strategy steps can propel you to market.

Is there a Moore's law for law? Can healthcare and FDA laws regulate convergent, exponential technologies?

Cosmetic or drug? Claims matter for body sculpting and slimming products, and all health and wellness products.

False and misleading educational products incur FTC wrath, particularly when it comes to claims about training pr protecting or improving the brain, treating ADD and ADHD, and marketing to children.

According to FDA medical device guidance - substantial equivalence in the 510(k) premarket notification process can be clearly determined if you know the underlying legal rules. One of the [...]

FDA's tobacco products Deeming rule imposes many regulatory requirements on tobacco products retailers, manufacturers, distributors, importers,including establishment registration and product listing.

FDA's tobacco products deeming rule hits companies with many compliance obligations for both existing tobacco products and new products "deemed" to be subject to FDA jurisdiction. This is a [...]

If you are a retailer, manufacturer, distributor, or importer of tobacco products, become familiar with the final rule by FDA Deeming Tobacco Products to be Subject to the Federal Food, Drug, and [...]

Digital health advances set healthcare law on edge because health tech develops exponentially while laws grow linearly.

Is my app an FDA-regulated medical device? That depends, in part, on whether it makes medical claims and whether the app itself, in FDA's view, diagnoses and treats disease.

FTC Big Data regulation tells companies how to use big data legally and responsibly, in FTC’s report, Big Data: A Tool for Inclusion or Exclusion? Understanding the Issues,

FTC tackles native advertising and sponsored content in an Enforcement Policy Statement on Deceptively Formatted Advertisements.