Life Sciences (FDA & FTC) Law
Companies that bring a healthcare product or technology to market understand the value of working with a top-notch FTC and FDA lawyer.
When you manufacture or distribute healthcare products, you come within the jurisdiction of numerous federal and state agencies that can stop health and wellness companies in their tracks. Among these, the federal Food and Drug Administration (FDA) and Federal Trade Commission (FTC), as well as state Attorneys General (AG), District Attorneys (DA), and a host of other agencies exercise enforcement discretion over healthcare products, including:
- Dietary Supplements and Nutraceuticals
- Medical Devices (including mobile medical apps)
- Medical Foods
- OTC Drugs
- Healthcare or health and wellness software
- Foods and food additives
- Homeopathic Drugs
- Stem Cell Products
FDA Analysis of Claims for Cosmetics, Dietary Supplements, Medical Devices, & Other Products
When FDA reviews a product, FDA makes a regulatory classification of the product into one of the categories that FDA regulates, such as: cosmetic, dietary supplement, medical device, or drug. Sometimes the product can be classified by FDA as a combination product, in which case the product must meet FDA’s legal requirements for both kinds of products (for example, a medical device and a drug).
FDA looks to the “intended use” for the product. FDA determines intended use from all the “labeling,” which includes not only the label on the product bottle or box, but also all of the marketing content. FDA has broad enforcement discretion and deep enforcement powers.
In its review, FDA typically evaluates the claims a company makes for its healthcare products.
For example, dietary supplements are defined in part of one, or any combination of: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by people to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, or extract. Dietary supplements can only be sold with “structure/function” claims. Therapeutic or “disease” claims are prohibited.
Similarly, cosmetics cannot make disease claims. Common cosmetics include eye and face makeup, perfumes, shampoos, deodorants, lipsticks, skin moisturizers, hair colors and any product that is intended to be “rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance”
If FDA determines that “disease claims” are involved for, say, a dietary supplement or cosmetic, then FDA will classify that healthcare product as a “drug” and the product will be deemed legally “misbranded.”
Under relevant FDA law, new drugs cannot be introduced into interstate commerce with a New Drug Application (NDA); and getting an NDA can be cost- and time-prohibitive for most dietary supplement and cosmetic manufacturers. As well, FDA can bring an enforcement action against dietary supplement and cosmetic distributors who make unlawful claims.
The biggest mistake when either manufacturers or distributors are marketing dietary supplements is underestimating the serious enforcement powers of FDA, as well as other federal and state agencies—and, as well, underestimating the zeal and speed with which class-action plaintiffs’ attorneys can move to shred an established company.
Animal supplement manufacturers are also subject to FDA jurisdictions. The claims that FDA allows for dietary supplements that are marketed to pet owners are very limited. Consequently, animal supplement manufacturers often get surprised by FDA enforcement action.
FDA also regulates medical devices. Even when medical devices are exempt from the more onerous FDA clearance (or even pre-market approval) process, FDA has other requirements that apply to medical device manufacturers, such as establishment registration, product listing, and cyber-security requirements in the development process. Often companies do not know whether or not they have a medical device that will be subject to FDA regulations; these companies will benefit from simply having a legal assessment as to whether the product is an ordinary consumer technology on one hand, or a regulable medical device on the other.
Physician Payments Sunshine Act (PPSA)
Sunshine act is a section of the Patient Protection and Affordable Care Act of 2010 that requires pharmaceutical manufacturers to collect comprehensive data of payments from physicians. The act has established certain procedures for drug and medical device manufacturers to give in annual cost reports to CMS. This is designed to increase transparency of financial relationships between physicians and manufacturers. Some categories of drugs, including OTC drugs, and medical devices are exempted to this rule, which may require an experienced healthcare attorney to determine.
Overlapping FTC Jurisdiction & Other Regulatory & Legal Dangers
While FDA and FTC have overlapping jurisdiction in the area of healthcare advertising and marketing, it is typically FTC that brings enforcement actions against advertising that FTC considers to be false, deceptive, or misleading. Whereas FDA enforcement action typically (but not always) starts with a warning letter, urging the manufacturer or distributor to take corrective action, a Civil Investigative Demand (CID) from FTC usually is the start of a long and onerous regulatory process. FTC penalties can be steep, including requiring a company to disgorge its profits to FTC.
In addition to the FDA and FTC regulatory dangers, waiting in the wings are plaintiffs’ class action lawyers, who can allege FDA or FTC violations, and seize on these allegations to make demands on dietary supplement, cosmetic, medical device, and other healthcare technology or healthcare software companies, in the millions of dollars.
Added to the regulatory and legal dangers are the prospect of enforcement action by federal agencies such as the Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), and the U.S. Department of Agriculture (UDSA), As well, states have their own legal equivalents to federal food and drug law, such as the California laws and state regulations regarding foods, drugs, cosmetics, medical devices, and biologics.
Our FDA and healthcare attorneys have handled investigations and enforcement by the California Department of Public Health (CDPH), as well as other compliance and enforcement agencies in a variety of situations, including dietary supplements, cosmetics, medical devices, and biologicals.
Our FDA, FTC, and Life Sciences Regulatory Practice
Our FDA, FTC, and Life Sciences regulatory practice evaluates clients’ strategies from conception to market, and can include:
- Adverse event reporting to FDA
- Customs and import issues related to FDA issues
- Due diligence review of FDA regulatory issues in M&A transactions involving cosmetics, dietary supplements, or medical device companies
- Establishment registration and product listing
- Legal advice on classification of medical devices (Class I, Class II or Class II)
- Legal advice on need for 501(k) vs. PMA for medical device
- Legal advice on General Wellness products
- Legal advice on combination products (e.g., drug-device)
- Legal counsel on the regulatory classification and pathway for a healthcare product
- FDA legal review of claims for cosmetics and personal care products
- FDA legal review of dietary supplement structure/function claims under DSHEA
- FDA legal review of health claims, nutrient content claims
- FDA legal review of animal supplements and nutritional products
- FDA legal review of dietary supplement labeling
- FDA legal review of testimonials and social media sites advertising dietary supplements or cosmetics
- Legal recommendations regarding substantiation
- FDA compliance attorney recommendations
- FTC compliance recommendations
- New Dietary Ingredient (NDI) review and submission
- Other regulatory and advisory services
- Preparation of pre-market notification to FDA
- Related partnership agreements, shareholder agreements, and corporate law issues
- Response to FDA Warning Letters
- Response to 483 inspections
- Review of advertising and marketing content for enforcement and litigation risks
- Review of related corporate governance and securities issues
- Review of related intellectual property issues (copyright, trademark, patent)
The FDA regulatory environment constantly changes. Our seasoned FDA lawyers have longstanding experience in handling FDA matters and in navigating clients through regulatory processes. In addition, our FTC & FDA compliance attorneys understand the enforcement side of FDA and FTC law and ably counsel clients who must respond to warning letters, civil investigative demands, or other enforcement activities.
In counseling biotechnology, pharmaceutical, medical device, diagnostic, software, and other healthcare companies regulated by FDA and FTC, our healthcare and FDA/FTC attorneys are experienced in designing innovative legal strategies and solutions for product manufacturers and distributors at the cutting edge of healthcare advancement and technology.