What is active ingredient testing for over-the-counter (OTC) claims?

Active ingredient testing for OTC claims evaluates whether key ingredients in a product perform as intended. These studies help support safety, efficacy, compliance, and marketing claims for over-the-counter products.

What types of active ingredient testing does Validated Claim Support provide?

Validated Claim Support provides active ingredient testing services including clinical testing, analytical testing, safety and efficacy studies, claims substantiation, and data validation to support OTC product performance claims.

How does active ingredient testing help support marketing claims?

Active ingredient testing provides data-driven evidence that helps confirm product performance, validate ingredient effectiveness, and support accurate, defensible, and compliant marketing claims.

Who should use active ingredient testing services?

Active ingredient testing is ideal for skincare brands, cosmetic companies, OTC product manufacturers, and marketers that need validated data to support product claims, regulatory compliance, and consumer trust.

Active Ingredient Product Testing and Clinical Claim Support

Name: Validated Claim Support
Address: 400 Frank W Burr Blvd Suite 105, Teaneck, NJ, 07666, US
Telephone: (201) 331-9300

Active Ingredients and Drug Concentration Claim Support Studies

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OTC Ingredient And Cosmetic Actives Pilot Studies

Over The Counter (OTC) products and active ingredients should be tested only at an FDA Registered Facility, and Validated Claim Support is proud to have registered with the FDA before we opened our doors.

FDA current Registration Search: https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

Validating Your Next Active Ingredient Claims, Clinically

If you are using regulated active ingredients, it is imperative that you follow posted rules and guidelines, and it is often recommended that you go above and beyond basic cosmetic safety testing practices.

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

Common Over The Counter Ingredient claim support studies include:

Acne and Lesion Testing
Certain Hyperpigmentation Ingredients
Dandruff Control
Retinol based Anti-Aging Claims
Hair Growth Studies
Anti-perspirant Testing

Institutional Review Board for Drug Product Testing

We generally recommend that studies involving known irritants or OTC level ingredients are submitted to an Institutional Review Board (IRB), also known in some places as Ethics Committee. IRB review allows us to get a full third-party safety review for the product and its intended use.

VCS maintains a relationship with Allendale IRB and Advarra IRB, and we are happy to work with any other third-party IRB that a sponsor may prefer. Please note it may take additional time to complete an IRB Submission with a new Institutional Review Board.

Outside of OTC Ingredients, VCS also recommends an external IRB whenever there are known primary irritants, or a medical device/drug delivery system is used, or whenever an at-risk panel is required for testing.

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Allendale IRB (Regulatory and Technical Associates) for Cosmetic Studies

Regulatory and Technical Associates, Inc. (RTA) is a toxicology, medical device development and preclinical drug, and regulatory affairs consulting company that specializes in a wide range of development activities. Our consultants are Board Certified in safety, regulatory affairs, toxicology and have many years of experience in toxicology, preclinical drug & medical device development, and regulatory affairs. We work with domestic and international clients and provide superior consulting services.

VCS focuses our attention on our clients’ needs in the petroleum, chemical, consumer product, food, cosmetic, medical device, and pharmaceutical industries. We’re known as a leading expert in women’s reproductive health & are registered with the FDA as a US Agent.

Our toxicology, preclinical drug & medical device development, and regulatory activities focus on the safety evaluation of new and established products. RTA has the required experience in preclinical drug development, toxicology, & regulatory affairs to help our client’s address the product development regulatory issues & safety that directly impact their ability to bring their products to market.

RTA routinely makes preparations for regulatory submissions for the FDA and other worldwide regulatory agencies. These include GRAS determinations, Food Additive Petitions, PMAs, 510(k)s, IDEs, CTDs, NDAs, IND Annual Reports, and INDs.

Preliminary safety testing and skincare irritation testing protects the consumer, ensures that you meet local and international regulatory requirements, and allows you to enter competitive distribution channels with hard requirements in place.

Drug & medical device product development is a difficult, time-consuming, and labor-intensive process. RTA gives you the consultation, support, and experience in toxicology, medical device and preclinical drug development, and regulatory affairs necessary to bring your products to market.

Advarra (Formerly IntegReview) For OTC and Medical Studies

With Advarra’s One-Touch Collaboration, your research team benefits from an outstanding service experience, a single point of contact, and consistent reviews from our integrated, single IRB. It is our goal to proactively facilitate your study experience and deliver unmatched support. Benefits include:

One central point of contact who knows you and your study(ies)
One stream of clear, coordinated communications
One study startup process for all sites, whether an institution or an independent research site
One set of forms, processes, and document templates for clear document management

Unlike other IRBs, Advarra offers a truly single IRB review and delivers white-glove service to our clients. We guarantee an outstanding, streamlined process from submission to final documentation.

Typically, Advarra can perform a full board review of a new protocol and informed consent for a multisite trial within 4 business days. An expedited review of a new minimal-risk protocol & informed consent can be completed within a couple of business days or even less depending on the urgency of your need. Advarra also provides rush review services to help you meet demanding timelines. As your partner, Advarra is committed to getting your trial started on time and helping you reach critical study milestones quickly.

VCS handles all documentation and the submission to IRB in a seamless, efficient process.

Pilot Studies and Preliminary Efficacy for Topical Drugs

For preliminary active ingredient studies, sometimes sponsors are still “honing in” on the most optimal active concentration for consumer use. In these cases, VCS often recommends a pilot study on 5-10 subjects where we will be able to review the different concentrations directly in comparison to one another.

This isn’t always possible for facial application or long-term products, however, it is a very powerful and cost-effective way to begin your journey into claims support, and it can provide a robust set of comparison-related information.

For final claim support studies, VCS recommends completing the study with a minimum of 30 subjects for statistical significance. This number is also the widely accepted industry standard.

Validated can also provide Clinical Photography on a small subset of subjects to help demonstrate novel Active ingredient Efficacy.

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