Over The Counter Claims

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
• 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
• 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.

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

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
• 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.

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 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.

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.

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 a lot of 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 in high resolution Clinical Imaging, VCS can provide 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. In the individualized clinical studies, we take high resolution close up images and follow product treatments out for a timeline that usually lasts 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 your reduction. Since we’re talking about Acne products, you can also describe a reduction in redness as a function of inflammation. These claims together can create a very compelling visual support package for your topical Acne Control Products.