3 min read
The United States (US) is home to a vast array of food and dietary supplements, each claiming to offer a unique set of benefits for consumers. From vitamins and minerals to herbal supplements and protein powders, the market is flooded with products promising to improve health, manage health conditions, and reduce risks of diseases. However, with so many options available, it can be challenging for consumers to make informed decisions about which products to choose. In this blog, we shall delve into the complex landscape of food and dietary supplement claims in the US, exploring the different types of claims, Regulatory requirements, and what consumers need to know to make informed choices.
What are Claims?
In the US, claims on food and dietary supplement labels denote the advantages of products, spanning health benefits, nutritional value, and unique features in comparison to competitor products. These claims are visible on both Front-of-Pack (FOP) and Back-of-Pack (BOP) labels.
Regulations and HAs
In the US, the regulation of claims on food and dietary supplements falls under the purview of the US Food and Drug Administration (FDA). The US FDA is responsible for ensuring that claims made on food and dietary supplement labels are truthful and not misleading. The US FDA also regulates the manufacturing, labeling, and marketing of dietary supplements to ensure that they are safe and effective.
Types of Claims
Three (03) main types of claims that can be used on food and dietary supplement labels in the US are:
- US FDA Health Claims: These claims must be supported by a “significant scientific agreement” among experts that the claimed benefit of a food or food component on a disease or health-related condition is true. When significant scientific agreement is lacking, qualifying statements may be required on the label to describe the strength of the evidence that supports the claim.
- US FDA Nutrient Content Claims: These claims describe the level of nutrients in a food product or supplement, and they require the US FDA’s approval.
- US FDA Structure/Function Claims: These claims describe the effect of a food or supplement on the structure or function of the human body. They must be truthful and not misleading. Also, they are not subject to pre-market scientific review and approval.
Regulatory Requirements for Claim Approval
To get a claim approved in the US, manufacturers must follow a specific pathway:
- Determine the Claim: The manufacturer must determine the specific claim they want to make on their product label.
- Conduct Scientific Research: The manufacturer must conduct scientific research to support the claim. This includes gathering data from clinical trials, epidemiological studies, and other sources of scientific evidence.
- Submit a Petition: The manufacturer must submit a petition to the US FDA, detailing the scientific evidence that supports the claim.
- FDA Review: The US FDA then reviews the petition and determines whether the claim is supported by a “significant scientific agreement”.
- Label Approval: If the claim is approved, the manufacturer can use it on their product label.
- Timeline: The US FDA’s review process can be lengthy and unpredictable, with possible claim rejection or suggested modifications. Timelines vary, based on the complexity of the claim and strength of the evidence. Health claims under the Food and Drug Administration Modernization Act (FDAMA) can be used one hundred and twenty (120) days post the notification of submission, pending the US FDA’s assessment. Overall, approval timelines for food and dietary supplement claims in the US are variable and case-specific.
Difficulties Faced by Manufacturers
Some of the challenges manufacturers may face in the process of getting their claims approved are:
- Scientific Evidence: Manufacturers must gather robust scientific evidence to support their claims. This can be a time-consuming and costly process.
- US FDA Review: As mentioned earlier, the US FDA’s review process can be lengthy and unpredictable, and manufacturers may face rejection or modification of their claims.
- Labeling Requirements: Manufacturers must ensure that their labels comply with the US FDA’s regulations, which can be complex and nuanced.
Consequences of Non-compliance
Non-compliance with the US FDA’s regulations can have severe consequences for manufacturers, including:
- Warning Letters: The US FDA may issue warning letters to manufacturers making unsubstantiated claims or violating labeling regulations.
- Product Recalls: The US FDA may order a product recall if it is deemed unsafe or misbranded.
- Legal Action: Manufacturers may face legal actions from consumers or Regulatory authorities if they violate the US FDA’s regulations.
To sum up, understanding the intricate terrain of food and dietary supplement claims in the US demands a profound grasp of various claim types, Regulatory mandates, and consumer needs. Freyr’s Regulatory experts specialize in guiding you through this complex landscape, ensuring adherence to Regulatory pathways and substantiation of claims with scientific evidence. By partnering with Freyr, you can confidently ensure that your products are safe, effective, and compliant with the US FDA’s regulations, which will, in turn, streamline your launch process in the US market. Contact Freyr today!
