FDA Legal & Compliance
Guidance
Guidance
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:
- Cosmetics
- 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
- Biologics
- Stem Cell Products
These legal and regulatory compliance challenges
FDA Analysis of Claims for Cosmetics, Dietary Supplements, Medical Devices, & Other Products
Physician Payments Sunshine Act (PPSA)
Overlapping FTC Jurisdiction & Other Regulatory & Legal Dangers
Our FDA, FTC, and Life Sciences Regulatory Practice
The healthcare industry is ever-evolving, as even established companies in other markets (such as, for example, consumer goods, online sales, and communications) add on features that track various health metrics (from number of steps walked to ECGs). Increasingly, new business models are restructuring healthcare practices. Concierge, VIP, and membership models reduce physician availability and drive patients into more exclusive, packaged healthcare programs. Corresponding with this surge in healthcare as a VIP service deliverable by practitioners, many companies are delivering healthcare as a product or software. The brick-and-mortar visit to the doctor is increasingly taking place as an online or mobile healthcare visit, with telemedicine and digital health (or “connected health” as the FDA has called it) leading the way.
Companies bringing a healthcare product or technology to market operate in one of the most complex
regulatory environments in the world. Our clients—from startup disruptors to global manufacturers—trust us to guide them through the overlapping jurisdictions of the FDA, FTC, and a patchwork of state and international regulations.
Your Legal Partner in Navigation FDA Legal & Compliance
Advertising and Marketing Claims
Our advertising and marketing compliance attorneys are highly skilled in Federal Trade Commission (FTC) and state law advertising issues. Advertising and marketing claims can plague a healthcare company with both liability and regulatory enforcement.
The Federal Trade Commission Act (FTCA) requires that all claims be truthful and non-misleading. With this one requirement, the FTCA sweeps everything into FTC’s jurisdiction, everything a company says publicly (including online) in its marketing materials about its services or products.
FTC can require that a company disgorge its unlawful profits; penalties can be in the millions.
One of the core requirements behind the FTC’s enforcement authority is that all claims be substantiated. As the FTC explains in the FTC Policy Statement Regarding Advertising Substantiation, the underlying requirement is that advertisers have a reasonable basis for advertising claims before they are disseminated. Failure to have a reasonable basis for the claims is an unfair and deceptive act or practice in violation of the FTCA.
This requirement severely limits the claims that can be made, independent of FDA concerns.
For claims involving healthcare services or products, those claims must be substantiated by competent and reliable evidence.
Biotechnology Issues
Biotechnology and life sciences companies can face a host of regulatory requirements, from FDA, FTC, and other three-letter agencies and require a realistic appraisal of the regulatory barriers and what they can do to overcome.
Agreements for Biotechnology & Life Sciences Clients
Our biotechnology and life sciences lawyers understand FDA, FTC, and relevant state laws that apply to your business. We provide regulatory compliance advice and corporate legal services, and can help you with:
- Acquisition Agreements
- Clinical Research Agreements
- Collaboration Agreements
- Dietary Supplement Structure/Function Claims
- Distribution and Manufacturing Agreements
- Drafting FDA-Compliant Product Labels
- Financing Agreements
- Intellectual Property and Technology Transfer
- Joint Venture Agreements
- Legal Review of Marketing Materials for FDA and FTC Compliance
Cosmetics Claims
Cosmetics companies can make claims for their products, so long as mindful of the way FDA and FTC laws and regulations shape the marketing environment.
Our Focus on Cosmetics Companies’ Legal Needs
Our legal team’s focus on cosmetics, dietary supplements, and medical devices gives us the expertise to help clients navigate FDA and FTC issues. We advise a range of clients on FDA and FTC legal questions, including:
- Advertisers
- Distributors
- Importers
- Manufacturers
- Resellers
- Our expertise includes products targeted to:
- Beauty
- Overall Health
- Weight Loss
Dietary Supplements Claims & Labeling
We can review or prepare labels and advise your company regarding products requiring FDA/FTC-compliant labeling such as dietary supplements, nutraceuticals, or cosmetics. We will assist with FDA compliance regarding foods, dietary supplements, drugs, or medical devices. We can determine whether product names and claims cause the product to meet the FDCA definition of “drugs” by making implied disease claims (versus allowed structure/function claims). We can review client’s evidence of substantiation of claims in light of federal and state substantiation requirements, and draft compliant disclaimers. In addition, we can provide legal review & advice relating to Marketing Materials (including brochures and main website) in light of FDA and FTC issues concerning claims, testimonials & endorsements.
The Dietary Health Safety and Education Act of 1994 (“DSHEA”) amends the federal Food, Drug & Cosmetic Act (“FDCA”), the foundational federal law governing foods, drugs, cosmetics, and medical devices.
Definition of Dietary Supplement
The DSHEA specifically defines a “dietary supplement” as:
- A product taken by mouth
- That is “intended to supplement the diet”
- And that contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanica
FDA Warning Letters
Our FDA compliance and regulatory lawyers are highly experienced in FDA compliance matters. We advise companies on the steps to take to help mitigate the prospect of receiving an FDA warning letter. We also advise businesses and individuals on the best ways to respond to an FDA warning letter, including compliance steps they need to take to preserve their business while appropriately responding to FDA concerns.
Failure to respond successfully to an FDA warning letter can result in more than just the cessation of the product’s development and sales. The FDA can follow-up the warning letter with civil fines, seizure of property, injunctions, and even (in the case of public safety concerns or intentional/reckless conduct), criminal prosecutions. In addition, the Federal Trade Commission (FTC) and state regulatory authorities can piggy-back off an FDA warning letter and begin their own enforcement.
Warning letters can damage the reputation to a company because the warning letters are posted on the FDA’s website which alerts the media. Shareholder confidence can be affected. The ability to get and keep federal and state government contracts can be diminished. Competitors may try to take advantage of the time and money you’ll need to focus on responding to the warning letter. And of course, once a dietary supplement, cosmetics, medical device, or other manufacturer or distributor receives an FDA warning letter, that company is on FDA’s radar for more serious enforcement.
Medical Device & Mobile Medical App Issues
Medical device companies face a host of regulatory challenges, including determining whether they are even subject to medical device regulation in the first place (or simply “general wellness” consumer products or non-medical mobile apps), and, determining the level of regulatory classification FDA will impose.
We help our clients with FDA issues related to medical devices, including:
- Classification of Medical Device (Class I, II or II)
- Establishment Registration
- Labeling
- Medical Device Reporting (MDR)
- Premarket Notification (510(k))
- Premarket Approval (PMA)
- Regulatory Requirements such as Quality System Regulation/Good Manufacturing Practices
- 513(g) Letter (arguing that product is not a medical device)
Off-Label Use
Our Off-Label Use lawyers counsels both individual clinicians and companies about FDA, FTC, and state law rules governing off-label use.
Off-label use is common among physicians, yet both practitioners and healthcare start-ups often need clear legal advice concerning off-label practices.
In U.S. v. Evers, the federal government charged Dr. Evers with misbranding a drug by using and promoting it for an off-label use (to treat arteriosclerosis instead of simply as a chelating agent). Dr. Evers’ off-label use was not itself considered illegal, since the FDA stated that a physician can, “as part of the practice of medicine, lawfully prescribe a different dosage for his patient, or may otherwise vary the conditions of use from those approved in the package insert, without informing or obtaining the approval of the Food and Drug Administration.”
However, the FDA argued that Evers had misbranded the drug by advertising the off-label use.
Even though the FDA rarely takes enforcement action against physicians, because of its reluctance to interfere with the practice of medicine, the FDA has taken action against manufacturers and distributors, including large pharmaceutical companies, for promoting a drug for off-label use. This is an arena of regulatory peril.
OTC & Homeopathic Drug Companies
How “Intended Use” Affects Your Product’s Regulation
It is the “intended use,” as established through product labeling, that can cause the FDA to consider a product to be a drug. The FDA notes that a product can meet the definitions of both cosmetics and drugs, by having two intended uses (such as a shampoo that is also intended to treat dandruff, or toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims). Such products must comply with the requirements for both cosmetics and drugs.
Regulation of OTC Drugs
Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Currently, certain — but not all — over-the-counter (OTC) drugs (that is, non-prescription drugs) that were marketed before the beginning of the OTC Drug Review (May 11, 1972) may be marketed without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a specific class of OTC drugs is final, those drugs must either:
- Be the subject of an approved New Drug Application (NDA), or
- Comply with the appropriate monograph, or rule, for an OTC drug
Our FDA, FTC, and Life Sciences
Regulatory Practice
Regulatory Practice
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 the 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.
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 related intellectual property issues (copyright, trademark, patent)
Review of advertising and marketing content for enforcement and litigation risks
Review of related corporate governance and securities issues
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 the FDA as a combination product, in which case the product must meet the 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, the FDA typically evaluates the claims a company makes for its healthcare products.
For example, dietary supplements are defined in part as 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. Nutritional supplements can only be sold with “structure/function” claims. Therapeutic or “disease” claims are prohibited.
Similarly, cosmetics cannot make disease claims. Everyday 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, the 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 the 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 jurisdiction. The claims that the FDA allows for dietary supplements that are marketed to pet owners are minimal. Consequently, animal supplement manufacturers often get surprised by FDA enforcement action.
The FDA also regulates medical devices. Even when medical devices are exempt from the more onerous FDA clearance (or even pre-market approval) process, the FDA has other requirements that apply to medical device manufacturers, such as establishment registration, product listing, and cybersecurity 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 regulated medical device on the other.
Physician Payments Sunshine Act (PPSA)
The Sunshine Act is a section of the Patient Protection and Affordable Care Act of 2010 that requires pharmaceutical manufacturers to collect comprehensive data on payments from physicians. The act has established certain procedures for drug and medical device manufacturers to submit 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 exempt from this rule, which may require an experienced healthcare attorney to determine.
Overlapping FTC Jurisdiction & Other Regulatory & Legal Dangers
While the FDA and the FTC have overlapping jurisdiction in the area of healthcare advertising and marketing, it is typically the FTC that brings enforcement actions against advertising that the 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 the FTC usually is the start of a lengthy 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 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.
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
