Over The Counter Claims
To Be or Not to Be (a Drug Product), That is the Question. . .
As an FDA Registered and Inspected 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.
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.
An “Active” Active Ingredient is a Must
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 Inaccessible
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.
For more information, please reach out to our team directly.
Main Areas of Focus for OTC and Topical Research
We have extensive experience working with the following OTC product categories:
- SPF and Sun Protection Products
- Dandruff Control Products
- Eczema, Psoriasis Treatments
- Anti-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
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.
Claim Support Validation Techniques
VCS can help support a wide range of label claims that consumers seek from their skincare and makeup providers in these areas including:
- Before and After Photography
- Biophysical Instrumentation
- Expert Clinical Grading
- Subjective Questionnaires
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
- Helps Even Skin tone
- Reduces Inflammation and Redness
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 woes.
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.
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.
Anytime you are using a word like “growth” that references a physiological change in the body, you can make the fair assumption that the consumer will start to think “drug product” and generally regulatory follows the same assessment parameters.
VCS can deploy our full-service hair salon for haircare studies, 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 improvement and hair thickening as functional cosmetic claims without going for the full drug claims.
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 have included. While Anti-Aging and skin tone are most often considered beauty or cosmetic claims, active ingredients can change the positioning of a given product very quickly.
Hyperpigmentation reduction, and age spot treatments, and secondary evening of skin tone all help to promote a more youthful appearance, and often times improvements in these conditions is 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.