FDA Legal & Compliance
Guidance
Guidance
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 piggyback off an FDA warning letter and begin their 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.
In most cases, we begin our review by determining how a product will be classified. Common classifications include:
Cosmetic
Dietary Supplement
Drug (Prescription or OTC)
Food
Medical Device
Medical Food
There are also combination products.
FDA Authority to Issue Warning Letters
The United States Food and Drug Administration (FDA) regulates other products than those in the name of the agency – food and drugs. The FDA regulates dietary supplements, cosmetics, medical devices, tobacco products, animal food, vaccines, OTC and Rx drugs, homeopathic medicines, biologics, combination products, and many other health-related items. Regulations include:
- Approving ingredients
- Mandatory labeling requirements
- False labeling
- Misbranding
- Proper manufacturing processes/GMPs
- What is considered credible scientific research for substantiation
The FDA regulations aren’t just guidelines. The FDA has numerous powers to enforce the Federal Drug and Cosmetic Act, including under other applicable federal laws (such as the Dietary Health Safety and Education Act of 1994, the Nutritional Labeling and Education Act of 1990, and the Fair Packaging and Labeling Act), and other regulations enacted by the Agency.
Before starting any enforcement actions, the FDA may conduct an investigation or review. This analysis by the FDA includes a visual inspection of the manufacturer’s physical plant; conducting chemical analysis of the products; and examining online, print, and media marketing materials.
Different Types of FDA Warning Letters
FDA warning letters generally come from one of the following FDA offices:
- Office of Prescription Drug Promotion Letters
- Office of Compliance/Immediate Office
- Office of Manufacturing Quality
- Office of Scientific Investigations
- Office of Unapproved Drugs and Labeling Compliance. Invalid labeling can result in an FDA warning.
- Office of Drug Security, Integrity and Recalls
What are FDA Warning Letters?
FDA warning letters are normally sent after less formal notices are made about a company’s regulatory violations. FDA warning letters should:
- Identify the regulation or law that is being violated
- Explain why the violation is of public concern
- State what corrective measures must be taken
- Provide a timeline for compliance
- Explain the consequences for non-compliance
FDA Warning Letters – Dietary Supplements
With dietary supplements, the FDA often focuses on claims that products can treat diseases vs. allowed structure/function claims. Structure/function claims generally involve statements about how the product affects the body or someone’s general well-being. Disease claims are subject to a much more rigorous scientific review than structure and function claims. Many FDA warning letters center around the issue of whether the product is a dietary supplement or a drug. Dietary supplements should be intended to supplement (not replace) a user’s diet. Dietary supplements typically include vitamins, herbs, minerals, and other substances that are taken orally and intended for ingestion.
Dietary supplements, that aren’t also considered drugs, generally don’t require FDA pre-approval. The maker of dietary supplements should be able to support its claims. A dietary supplement maker is required to submit its claims to the FDA for approval – within 30 days after the marketing of the product begins.
- Warnings for invalid labeling. The FDA can issue warning labels if the labeling does not include or contains false information regarding:
- The nutritional elements
- The list of ingredients
- The identity of the supplement
- Claims about the dietary supplement
- The net quantity of the contents
- Pre-market Notification of New Dietary Ingredients
- Other Labeling Information
- Invalid claims – misbranding. Dietary supplements can’t make disease claims. Health claims and nutrient claims must be carefully worded. The FDA will examine the product’s name, the product’s label, the product’s indications (ex., for relief of ___), and the product marketing materials.
Warnings can be issued if the required information is not adequately prominent and conspicuous and for many other reasons. The best course of action is to review each claim with an experienced FDA lawyer before the product labeling and marketing stages begin. Developers should also meet with a skilled FDA lawyer before beginning the manufacturing of the dietary supplement. Warning letters can be issued by the FDA for failure to maintain good manufacturing processes. Maker, suppliers, and producers of dietary supplements should be able to show that their manufacturing practices meet industry standards. The FDA may issue a warning letter if the manufacturing standards are subpar, there are nonapproved ingredients, the amounts of the ingredients are not correct, or the product is contaminated.
FDA Warning Letters – Cosmetics
Cosmetics companies can’t make structure/function claims or disease claims. Cosmetic makers and sellers can only make claims allowed by cosmetics law.
The Federal Food, Drug & Cosmetic Act (FD&C Act) has strict definitions for cosmetics are such as that they should be use to clean, beautify, or promote one’s appearance. Cosmetics include lipsticks, skin moisturizers, perfumes, facial and eye makeup, shampoos, toothpaste, and other products.
FDA warning letters can be issued if the cosmetic is a drug. An experienced FDA lawyer can explain and how companies verify – the often-thin line between being considered a cosmetic or a drug. The intended use of the product determines whether it is a cosmetic or a drug.
Some products can be considered both a cosmetic and a drug. For example, an anti-dandruff shampoo may fit both categories because it cleans the hair (a cosmetic use) while treating dandruff (a drug use). The FDA provides good manufacturing guidelines for cosmetics but, unlike drugs and other products, doesn’t have specific manufacturing requirements. FDA warning letters can be issued if cosmetics don’t have proper labels or the labeling is false or makes misrepresentations. Cosmetics should be labeled according to the Cosmetic Labeling Manual. Cosmetic companies can’t have it both ways. They can’t tell the FDA that their product isn’t a drug but then tell consumers that their product acts like a drug. For example, claims that cosmetics can reduce cellulite, treat acne, or that make health-treatment claims will be questioned by the FDA.
Many warning letters are sent to cosmetic makers on the basis that a cosmetic is classified by FDA a new drug – which requires that the company file a New Drug Application.
FDA Warning Letters – Medical devices
Medical device companies face a host of regulatory challenges, including determining whether they are even subject to medical device regulation in the first and determining the level of regulatory classification the FDA will impose. Our lawyers work to determine if the device is subject to regulation, how the device will be classified, whether premarket approval is required, the labeling requirements, and other FDA concerns.
FDA warning letters can be issued if the product isn’t properly labeled, the marketing is false, the device doesn’t do what it is intended to do, the directions on use aren’t adequate, and for other reasons.
FDA Warning Letters – Other products
The FDA also issues warning letters for these products:
- Food
- Drugs
- Radiation-emitting products
- Vaccines, blood and biologics
- Animal and veterinary products
- Tobacco products
Red flags that cause the FDA to issue a warning letter
By being proactive, reviewing internal procedures, and examining the merits of claims; companies can reduce the odds of receive an FDA waning letter. Some red flags an experienced FDA attorney will review are:
- False claims or disease claims for dietary supplements and cosmetics. For example, claiming that dietary supplements can treat diseases such as cancer and diabetes is a red flag. As an illustration, in February, 2019, the FDA and the FTC sent joint letters to Gold Crown Natural Products, TEK Naturals, and Pure Nootropics, LLC, challenging the following claims.
- In the Gold Crown Natural Products letter, the following claim was challenged: “Many experiments have been conducted on this and it is proved that melatonin supplements are used to cure Alzheimer’s disease.”
- TEK Naturals claimed as “clinically shown to help diseases of the brain such as Alzheimer’s and even dementia.”
- Pure Nootropics, LLC claimed that some of its products had benefits for dementia, schizophrenia, Alzheimer’s, and Parkinson’s, among others.
- Failing to examine items that a quality department should find
- Receipt of an FDA 483 notice. This notice is usually answered after an FDA inspection.
- Numerous FDA inspections
- Multiple responses by the FDA indicating they aren’t satisfied with the manufacturing materials, the labels, or the marketing
- Not addressing adverse effects of dietary supplements, cosmetics, foods, and drugs
- Customer complaints
- Media complaints
- Notices of unproven claims and improper labels
What to do when you or your company gets an FDA warning letter
Often, if your business works with an experienced FDA warning letter attorney, the company can continue operations or resume work after adjustments are made.
Our FDA lawyers work to understand exactly what laws and regulations the FDA claims are being violated.
- We begin by reviewing whether your product is being properly categorized.
- We seek to extend the timelines for compliance when necessary.
- We advise our clients on what remedies the FDA is likely to accept.
- Our FDA lawyer work to verify your claims.
Our healthcare and FDA lawyers explain what follow-up steps the FDA will likely take to show the requirements of the warning letter are being met. Common follow-up steps include additional chemical testing, site-inspections, and other measures to verify the company is working towards compliance.
The FDA’s enforcement powers and penalties
FDA warning letters should indicate the possible penalties for not complying with the FDA warning letter. Possible penalties can include:
- Civil fines and penalties. These costs can be quite substantial.
- Seizure of products. If the FDA believes a product violates the act, that misbranding has occurred, or the that product is adulterated in some way – it can seize the products and remove them from the stream of commerce.
- The FDA can seek a court order enjoying the makers and sellers of the product from violating applicable law or regulations
- Criminal prosecution. Corporations can be subject to criminal fines up to $500,000 if someone dies as a result of a violation of the Food, Drug, and Cosmetic Act – individuals can be fined up to $250,00 someone dies due to a violation. Imprisonment is also possible.
Contact us before the FDA warning letter comes, for help with compliance that makes strategic sense for your healthcare business. Our lawyers help you understand the FDA requirements such as manufacturing best practices, label requirements, false claims, and misbranding. If an FDA warning letter does arrive, we’ll help you craft a timely process and review the appropriate remedies.
Or contact us immediately when a warning letter comes. Typically FDA will give you a limited window to respond. Call us at 310-844-3173 or use our online contact form to schedule a consultation and we can discuss how you can best respond to an FDA warning letter regarding your product and marketing claims.
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.
