OTC Drugs Legal & Compliance
Guidance
Guidance
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 the FDA or conform to final regulations specifying conditions whereby they are typically 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 sold without specific approval pending publication of final regulations under the ongoing OTC Drug Review. Once a regulation covering a particular 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 Food and Drug lawyers understand the regulatory distinctions between dietary supplements, homeopathic products, medical foods, prescription drugs, and over-the-counter drugs, and the way that product positioning and marketing can affect regulatory classification by the FTC. Let our legal team guide you through the complex laws and regulations that can affect the way you bring your OTC drug to market.
OTC Monographs
Suppose there is an FDA OTC monograph on a given drug category. In that case, the monograph will establish conditions under which the OTC product in that category is generally recognized as safe and effective and not misbranded. Accordingly, the monograph will specify the necessary statement of identity, indications, warnings, and directions. A drug claim outside a monograph is problematic. Put another way, if you have a product that would fall within a particular drug category based on its claim, then your product must comply with the monograph. For some monographs, your product must have at least one of the ingredients in the monograph, and for others, your product must have all of the ingredients. Suppose you have a product that does not fall within a given drug category in the OTC monographs because of its claim. In that case, the list of OTC active ingredients may nonetheless provide references to regulations that prohibit certain kinds of statements regarding the ingredient. For example, no claim can be made for chamomile as a digestive aid product. The relevant regulations do not give permission for any particular claims to be made regarding an ingredient; they only prohibit particular claims.
Suppose an ingredient is listed in 21 CFR 310.545 (Drug Products Containing Certain Active Ingredients Offered Over-The-Counter (OTC) For Certain Uses). In that case, the regulation provides (depending on which subsection the ingredient is listed), that either:
A number of active ingredients have been present in OTC drug products for various uses, as described below. However, based on evidence currently available, there are inadequate data to establish general recognition of the safety and effectiveness of these ingredients for the specified uses;
Any OTC drug product that is labeled, represented, or promoted for the uses specified and containing any active ingredient(s) as specified in paragraph (a) of this section is regarded as a new drug within the meaning of section 210(p) of the Federal Food, Drug, and Cosmetic Act (the Act), for which an approved new drug application under section 505 of the Act and part 314 of this chapter is required for marketing. In the absence of an approved new drug application, such product is also misbranded under section 502 of the Act;
Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for the OTC uses and containing any active ingredient(s) as specified in paragraph (a) of this section is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter; or
Any OTC drug product that is not in compliance with this section is subject to regulatory action if initially introduced or initially delivered for introduction into interstate commerce after the dates specified in paragraphs (d)(1) through (d)(37) of this section.
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.
