OTC Drug Claims

Many natural products on the market contain ingredients or formulations which already meet the Food and Drug Agency's (FDA's) Over-The-Counter (OTC) drug requirements.

Analysis of your product's formulations allows our team to identify potentially strong marketing claims you could be making, unlocking access to an entirely new market.

Structure / Function Claims

If your natural product is intended for ingestion and includes phrases such as "supports a healthy immune system" or "improves mood," it's required to have a substantiation dossier and be registered with the FDA.

Our team can manage this entire process for you, keeping your marketing in compliance.

Protect your bottom line with health claim substantiation

Many companies focus on the US Food & Drug Administration (FDA) when it comes to labeling compliance, but few realize that the US Federal Trade Commission (FTC) has jurisdiction over the health claims contained in your product’s labels, advertising, and marketing. Even if your product has a successful clinical trial, your marketing team must still comply with limitations regarding how you communicate those findings. How can you be sure your claims are sufficiently substantiated?

When you include a health claim on your labels, website, or other advertising methods, you are claiming that a relationship exists between your product and a specific health outcome. This claim must be substantiated with sufficient high quality scientific evidence. Companies with insufficient evidence to substantiate claims are at risk of adverse actions from regulatory authorities.

Formulation Analysis

Identify untapped health claims you could be making–or learn how minor tweaks to your formula could unlock new marketing potential.

Dossier Compilation & Review

Our team can compile your substantiation dossier or review the dossier your team has compiled, providing an expert analysis and commentary.

Save Time

Our expertise in claims compliance and integrative health saves time and money

Unlock New Potential

Discover new marketing strategies and untapped claims you could be making

Peace of Mind

Rest easy knowing your express and implied claims are fully substantiated

Ready to learn how we can help you grow?

Tell us more about your goals to receive a FREE quote and 30 minute consultation.