Most people think of Over-the-Counter (OTC) as cough syrup or something you can buy from the drugstore without a prescription. While that is true, it can also refer to drugs and other products with “medicinal” ingredients. A few examples of OTC products are decongestants, topicals that relieve itches, and treatments for common bodily aches, like Tylenol.
But, most people don’t think of sunscreen, hand sanitizer, or eczema lotion as being an OTC product, much less a “drug.” At Tropical Labs, we receive many inquiries for OTC products, with sunscreen being one of the most common requests and one of the harder custom formulas to bring to market in terms of expense, compliance, and time involved.
OTC custom formula manufacturing is neither viable for small quantity orders (less than 5000 units), nor for fast product launches. If you have been yearning to develop and launch the next innovative OTC product, read on. This article will walk you through Tropical Labs’ process of R&D formulations for OTC products. Our goal is to give you a clear understanding of the expense, development time, and regulations associated with OTC product development.
The good news is: With our multi-decade experience, Tropical Labs can help you stay fully compliant while also avoiding the OTC pitfalls that can snare you.
What is an OTC?
It’s pretty simple: If you make a claim on your label, it must follow rules and regulations set forth by the Food and Drug Administration (FDA) for OTC products. You may think you have the next best eczema lotion, but even just calling your product an “eczema lotion” is a claim. What about an SPF30 lotion? With this product, you are claiming that it will protect against sunburn according to the parameters set forth by the FDA for SPF30. Hand sanitizer? Your claim is that it kills germs. In short, if there is a claim, there is a path of compliance you have to follow, or you risk drawing the attention of the FDA or the Federal Trade Commission (FTC).
Making OTC Claims
When advertising OTC products to target markets, manufacturers create claims describing the functions, applications, and ingredients the items contain. OTC product claims have to be substantiated by the FDA monograph. This means, you can only claim what the monograph allows for. If you marketed, even if true, claims that were not covered under the monograph, they would be considered misbranded by the FDA.
If you have ingredients that you think are the “cure” or efficacious for an ailment, the easiest way to bring a new formula to market and make that “claim” is to add the ingredients in the inactive ingredient section and select a standard monograph active. For example, Eczema has a monograph for salicylic acid.
If you have essential oils that you think are the key to the cure, you would add them in the inactive ingredients but use the monograph for salicylic acid as an active, to make the claim for Eczema relief.
We have often had clients report amazing discoveries with a combination of natural ingredients and they want to “claim” and report the success of their anecdotal evidence, but they cannot. Even if, for example, rosemary extract grew back hair, you would not be able to make this claim without finding a monograph that already exists and is approved for the claim of hair regrowth.
There are three ways to safely make product claims:
1. HARD: New Drug Application (NDA)
If a company wants to base a claim on a new, raw material or new formulation, they will have to prove to the FDA that the formula or ingredients work as described. This process is very expensive, time consuming, and is closely related to what pharmaceutical companies go through to bring a drug to market.
2. EASY: Follow The FDA Monograph (https://dps.fda.gov/omuf)
The FDA has a list of ingredients that they consider viable for making a claim. When you follow the monograph, you can make a claim; just be sure to file your National Drug Code (NDC) number. If you follow a monograph, you will pick an “active material” already approved by the FDA when used in the formula at the percentage required by the FDA.
In other words, a monograph is a predetermined product “recipe” that, when followed, the FDA allows companies to make the established claim tied to that recipe, and that the product is safe and effective enough to be sold over the counter. Adhering to the FDA guidance means you can safely make a claim for the given active material.
Many times, new and innovative ingredients are “hidden” as inactive ingredients because to use the new ingredient as an “active” would cause the (now new) formula to fall out of the parameters of the monograph. In such a case, the product would have to be filed as an NDA.
3. EASY: Follow Cosmetic Claims
Cosmetic claims are not the same as OTC claims. Cosmetics are typically defined as intended for external use (skin, hair, lips, nails), or perhaps related to teeth, with an exclusive focus on cleaning, perfuming, changing appearance, correcting odors, or protecting. Cosmetics claims typically involve a temporary effect imparted by the product. Any claims related to treating or preventing disease would make the product a drug and therefore subject to FDA regulation.
The short list of cosmetics claims that can be made are:
- Cleanses skin
- Enhances beauty
- “Alters, reduces or minimizes the appearance of” a characteristic, such as wrinkles
OTC “Drug Facts” Label
The “Drug Facts” label on OTC products provides information, directions, warnings, and approved OTC product use. The FDA regulates OTC manufacturers to observe the following format in creating “Drug Facts” labels:
- Active ingredients and amount in each dosage unit
- Product purpose
- Product uses (indications)
- Specific warnings (e.g., side effects, when to consult a doctor)
- Dosage instructions
- Inactive ingredients
- Other information to help customers avoid ingredients that may induce allergic reactions
Additionally, the “Drug Facts” label will fall under a monograph claim by FDA. As mentioned above, OTC products must be FDA-registered with a National Drug Code (NDC) number.
OTC R&D Formulation Process
Through the R&D formulation process, Tropical Labs makes product development a breeze for our clients — from formulating and packaging compatibility, to stability and full compliance and regulatory review. We combine science, technology, and nature to manufacture products tailored to our customers’ specifications. Our in-house chemists and lab techs abide by the highest quality standards to develop new formulations for our patrons. Specifically, Tropical Labs’s R&D formulation for OTC products follows this process:
- Confirmation and acquisition of desired ingredients
- Full specification of the formula
- Claims processing
- OTC formulation (organic, gluten-free, kosher)
- Hero ingredients selection
- Ingredients to avoid specification
The estimated time to formulate an OTC product ranges from nine to 12 months. Take a look at the OTC flow process infographic for a convenient overview. Once the formulation process is complete, products undergo rigorous testing to ensure compliance with regulations. This procedure often takes at least six months before market introduction.
Stability alone for a two-year shelf life on an OTC product requires six months, or three months for a one-year shelf life. One strategy we have seen clients use is they will launch with a one-year expiration date to begin with, while continuing their two-year testing. As soon as the two-year testing is complete, the expiration date is updated in production runs.
Testing and Quality Assurance
At Tropical Labs, our highest priority is quality. We make sure our products are thoroughly tested to ensure our formulation’s effectiveness, safety, and long shelf life.
For our OTC products, we regularly run the following tests for quality assurance:
- API Efficacy testing
- Microbial (impurities)
- Specific gravity
- PH balance
- Heavy metals
- FTIR – identity testing
Confidently Launch Your OTC Products With Tropical Labs
Tropical Labs is committed to helping our clients succeed by formulating and thoroughly testing exceptional, effective, and FDA-compliant OTC products that best suit their demands and specifications! We have assembled a team of specialists with extensive experience, integrity, and creativity to bring your product vision to life and make your launch as smooth as possible.
With our R&D process, Tropical Labs can help you build superior OTC products from start to finish — product conceptualization, formulation, testing, artwork and packaging, and approval and product launching. You can even choose between Private Label and Ready-To-Finish to launch your products!
Contact us today to bring your next big product to market!