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.
Ready to learn how we can help you grow?
Tell us more about your goals to receive a FREE quote and 30 minute consultation.