The United States (US) hosts a vast array of food and dietary supplements—each asserting to provide a unique set of benefits for consumers. From vitamins and minerals to herbal supplements and protein powders, the market is inundated with products that promise to enhance health, manage health conditions and lower risks of diseases. However, with such numerous options available, it can be challenging for consumers to make informed decisions regarding which products to select. In this blog, we shall explore the intricate landscape of food and food supplement claims in the US: examining the various types of claims, Regulatory requirements and what consumers must know to make educated choices.
What are Claims?
In the US, food and dietary supplement labels include claims about the product's healing properties, nutritional value, and special characteristics that distinguish it from competitor products. Such claims can be found on Front-of-Pack (FOP) and Back-of-Pack (BOP) labels.
Regulations and HAs
The regulation of claims on food and dietary supplement labels in the US falls primarily under the jurisdiction of the US FDA. The US FDA is tasked with ensuring that claims by and on food and dietary supplement labels are truthful and not misleading. The US FDA 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 require a “significant scientific agreement” between experts in such a manner that one can be sure of the benefits of food or food components in disease or health-related conditions. Should there be no significant consensus among the factors of health, qualifying statements on the label to define the strength of the evidence that supports the claim.
- US FDA Nutrient Content Claims: These specify the levels of nutrients in a product or supplement, and they must receive US FDA approval.
- US FDA Structure/Function Claims: These claims concern the effect of food or supplements on the structure or function of the human body. They cannot be false or misleading. They do not require premarket review or scientific approval.
Regulatory Requirements for Claim Approval
The US Regulatory requirements for obtaining exposure claims involve the following points:
- Determine the claim - The manufacturer shall determine the claim to be made with respect to the product label.
- Scientific research - This shall entail scientific research into support for that claim, gathering data from clinical trials, epidemiological studies, and other sources of scientific evidence.
- Submission of a Petition- The manufacturer shall submit a petition directed to the US FDA that explains the scientific evidence supporting the claim.
- FDA Review - The US FDA then appraises the petition and dictates whether the claim attains "significant scientific agreement."
- Label Approval - If approved, the manufacturer may proceed with the claim, and it will feature on the product label.
- Timeline - The length and unpredictability of the review by the US FDA can be a long process, with possible rejection or suggestions for modification. Depending on the complexity of the claim and the strength of the submitted evidence, timelines will fluctuate. Health claims are allowed to be used under the Food and Drug Administration Modernization Act (FDAMA) for 120 days post notice of submission, pending the US FDA assessment. In all, timelines for obtaining claims approval for food and dietary supplements in the US, therefore, vary and remain particular to a given case.
Difficulties Faced by Manufacturers
These are some of the challenges faced by manufacturers while getting their claims approved:
- Scientific Evidence: Gathering sufficient scientific proof to back the claims is very time-consuming and expensive.
- US FDA Review: As discussed, considering the lengthy and unpredictable review of the US FDA, it is not odd for a rejection or modification of claims to happen.
- Food Labeling Requirements: Labels must comply with the highly complex and tedious regulations set by the US FDA.
Consequences of Non-compliance
Noncompliance with the US FDA means severe consequential damage to manufacturers, namely:
- FDA Warning Letters: The FDA may issue warning letters for making unsubstantiated statements or claims.
- Product Recall: If the FDA considers a product to be unsafe or misbranded, it may order it recalled.
- Legal Actions: If US FDA regulations are violated, a manufacturer may find itself in trouble in civil or criminal proceedings with consumers or Regulatory authorities.
In conclusion, it needs to be emphasized that a mindful and nuanced understanding of the food and dietary supplement claims in the US requires a thorough knowledge of different claims, Regulations, and consumer requirements. The Regulatory experts at Freyr will help you navigate through the intricacies of this landscape with FDA compliance to Regulatory pathways with substantiation of claims with scientific evidence. Partner with Freyr to ensure that your products are safe, effective, and compliant with the Regulatory requirements of the US FDA Regulations, allowing for a smoother process in handling the launch of your products into the US market. Reach out to Freyr today!
