What are over-the-counter (OTC) claims?

Over-the-counter (OTC) claims are product performance, safety, or efficacy statements made for non-prescription products. These claims often require clinical testing, consumer perception studies, and data-driven substantiation to support compliant marketing.

What types of OTC claims testing does Validated Claim Support provide?

Validated Claim Support provides OTC claims testing services including clinical trials, safety and efficacy studies, consumer perception testing, active ingredient testing, acne testing, dandruff testing, hair growth studies, and claims substantiation.

How does OTC claims testing help support marketing claims?

OTC claims testing provides scientific and consumer-based evidence to help validate product performance, support compliant advertising claims, reduce legal risk, and build consumer trust.

Who should use OTC claims testing services?

OTC claims testing is ideal for skincare brands, haircare companies, personal care manufacturers, cosmetic companies, and marketers that need validated data to support non-prescription product claims.

OTC And Drug Product Clinical Support

Dandruff, SPF, Redness Reduction, Acne Products, Psoriasis, Melasma Studies, and Custom Anti Aging Support

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Over The Counter Topical Claims

As an FDA Registered and Inspected Lab facility, VCS can help you maximize your OTC level claims and conduct pilot research or proof of concept studies on new, novel ingredients.

We have extensive experience working with standard “drug level” skincare claims, and we can help ensure that you are not overstating your goals or product performance and are staying in line with local and international regulatory requirements.

To Be or Not to Be (a Drug Product), That is the Question. . .

OTC level claims generally have posted regulatory guidelines as well as best industry practices for safety and efficacy, so it is particularly important to bring in a claims consultant for relevant international markets of interest.

Whether you decide to market your product as a drug or a skincare/cosmetic product, VCS has your back.

Drug Claim Secondary Regulatory Requirements

To make drug claims in most markets, it is imperative to have an approved active ingredient in the formula to meet regulatory requirements.

Regardless of whether or not your product actually has the capability to treat or improve an underlying condition, you must follow all appropriate posted regulatory guidances.

A perfect example is any product that references Acne in the US. The word “Acne” automatically classifies your product as a drug product if it is used in your marketing materials, and as such if you use it you must:

Have valid clinical data showing that your product can indeed improve Acne in some way
Include an approved FDA Active Ingredient (drug) which is formally listed, such as Salicylic Acid

Without a Drug Active, Drug Claims are Strongly Not Recommended

While there are many new natural and homeopathic remedies which can improve the underlying conditions associated with OTC level conditions (lesion counts, oil/sebum reduction, reduction in redness etc) it is imperative that you do not overstep your claims unless you have followed all the respective monograph rules.

Simply stating a word like “Acne,” “Dandruff,” or “Scars” can have drastic implications for a brand. Validated always advises speaking to a claims and label attorney before making any “Drug” oriented claims. When in doubt, we always recommend caution and sticking to softer marketing language.

An “Active” Active Ingredient is a Must

Anytime you use a word like “growth” it references a physiological change in the body, and you can make the fair assumption that the consumer will think “drug product”. This risks triggering regulatory oversight.

VCS can run your hair care study in our full-service hair salon, bridging the gap between take home and professional use products.

We can also bring in our consulting Dermatology group for more detailed grading and assessment criteria.

For non-drug claims, VCS can also look at hair volume and density improvement and hair thickening as functional cosmetic claims without going for the full drug claims.

For more information, please reach out to our team directly.

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Main Areas of Focus for OTC and Topical Research

We have extensive experience working with the following OTC product categories:

OTC Claims

Anti-Inflammatories
SPF and Sun Protection Products
Dandruff Control Products
Eczema, Psoriasis Treatments
Acne Products
Scar care and Wound Healing
Anti-Pruritic and Anti-Itch Products
Hyperpigmentation and Age Spot Reduction
Chronic Dermatitis
Hair Regrowth/Hair Growth
Eyelash Growth
Anti Aging and Wrinkle Reduction
Collagen and Skin Firmness
Cellular Regeneration

When conducting drug level claims validation, it is particularly important to ensure you are using an FDA registered and inspected testing facility for compliance.

In addition to these OTC categories, VCS also has extensive secondary experience designing novel outside the box pilot and full-blown clinical studies, and we would be quite happy to discuss your next clinical study directly with your team.

Acne, Pores and Comedones

While more common in young adults and adolescents, pimples, acne, and generally troubled skin can be a major source of self-consciousness and frustration.

It’s more important than ever to differentiate your acne products for the global consumer, and we can help you do so with a number of different study designs.

Sample Acne Claims

Reduces the Appearance of Acne Lesions
Helps Reduce Oil/Oil Control
Reduces the Appearance of Acne Lesions
Reduces Inflammation and Redness
Non-Comedogenic
Additional Considerations

It’s more important than ever to differentiate your acne products for the global consumer, and there are quite a few different methods to do so.

Consider compiling oil reduction claims via Sebumeter instrumentation with some Validated Clinical Photography images to really help your product stand out.

Dandruff Control Studies

There are multiple natural and approved drug level products which can help to reduce redness, flaky skin, and battle some of the causes of Dandruff and other scalp issues.

Reduction can be quantified via expert grading, plaque collection and d-squame, subjective user perception, and clinical photography.

While natural remedies exist, directly using the term dandruff is a “red flag” for products and must be treated as a full OTC level product launch with relevant support.

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Hair Growth Studies

Hair growth goes hand in hand with youthful, healthy appearance in men and women. Losing your hair due to aging or secondary underlying conditions can be a major concern for consumers around the world, and treatment products can help to boost confidence and improve the overall appearance of end users.

Pigmentation and Anti-Aging

Depending on the nature of your product it may cross-over into the drug realm simply because of an ingredient that you included. While Anti-Aging and skin tone claims are most often considered beauty or cosmetic claims, active ingredients can change the positioning of a product very quickly.

Hyperpigmentation reduction, age spot treatments, and evening of skin tone all help to promote a more youthful appearance, and oftentimes improvements in these conditions are used to further support Anti-Aging Claims.

Active Ingredient Testing and Claims

If you are using Monograph level ingredients, it is imperative that you follow all posted rules and guidelines, and it is often recommended that you go above and beyond when it comes to product safety.

Active ingredients such as Retinol have been shown to have some irritating properties, and any known irritants must be treated with an additional standard of care.

There are many different underlying conditions which can lead to variations in skin tone and color, and some of them are more severe than others. As an FDA Registered Clinical Support Laboratory, Validated Claim Support is capable of testing skincare and beauty products outside of drug monographs, and we’re capable of testing new OTC and drug level ingredients for efficacy and eventual approval as well. Clinical Photography and Before and After images allow you to accurately and reproducibly demonstrate the changes in pigmentation over time, and as the world’s leading provider of high resolution Clinical Imaging, VCS will deliver a truly market leading visual support package for your products and your brand.

Acne studies can be conducted at the global level or we can follow individual spot treatments to see how they impact isolated lesions or pimples. Every study is individually designed, and we take high resolution close up images and follow product treatments for a timeline that usually lasts at least a couple of days. We analyze the size of the lesions as well as the color intensity using L*A*B* colorspace, and this allows you to have two main methods to describe improvement. Since we’re talking about Acne products, you can also describe a reduction in redness as a function of inflammation. Together these claims can create a very compelling visual support package for your topical Acne Control Products.