Have you ever been tempted to buy a food item because the packaging stated it was “low in sodium” or “low in fat”? It is important to understand what these claims mean so that you can make informed decisions about the food you buy for yourself and your family. We can review the evidence for customer claims in light of federal and state substantiation requirements, and draft liability waivers that comply with the regulations. The FDA has published a guide on interim procedures for qualified health claims (see the interim procedures for qualified health claims on the labeling of conventional foods for humans and dietary supplements for humans) and on the scientific criteria used by the agency to evaluate health claims (see the Evidence-Based Review System for the Scientific Evaluation of health claims).Health claims describe the relationship between a food, a food component, or an ingredient in a dietary supplement and the reduction in the risk of a disease or health-related condition. This fact sheet from the Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH) provides information that should not replace medical advice.
The requirements that govern the use of nutrient content statements help ensure that descriptive terms, such as high or low, are used consistently for all types of food products and are therefore meaningful to consumers. Before a drug is allowed to be marketed, manufacturers must obtain FDA approval by providing convincing evidence that it is safe and effective. Product declarations serve to provide consumers with information about the product and can help them determine which products are best suited for them. Health claims describe a relationship between a food substance (a food, a food component, or an ingredient in a dietary supplement) and the reduction in the risk of suffering from a disease or health-related condition. The FDA has published guidance on how a company can file such a notification and use authorized health claims based on health claims. These three types of statements do not require prior approval from the FDA, but the manufacturer must demonstrate that the statement is true and not misleading and must send a notification to the FDA with the text of the statement no later than 30 days after marketing the dietary supplement along with the statement.
Therefore, the food would have to meet the nutritional criteria for a “low nutrient” statement or carry a disclosure statement stating that it does not meet the requirements for the declaration (for example, although the FDA issues enforcement discretionary letters to the petitioner requesting the qualified health claim), qualified statements are available for use in any food product or dietary supplement that meets the discretionary conditions of compliance specified in the charter. It is essential to be aware of what health claims are allowed on dietary supplements so that you can make informed decisions when purchasing them. It is important to understand what these claims mean so that you can make informed decisions about which dietary supplements are best suited for you. It is also important to be aware of what evidence is required by law to support these claims so that you can be sure that any product you purchase meets all legal requirements. The FDA has published guidance on how companies can file notifications and use authorized health claims based on scientific evidence. Companies must demonstrate that their statements are true and not misleading before they can market their products.
Furthermore, companies must submit notifications to FDA with their statements no later than 30 days after marketing their dietary supplements. In conclusion, it is important to understand what health claims are allowed on dietary supplements so that you can make informed decisions when purchasing them. It is also important to be aware of what evidence is required by law to support these claims so that you can be sure that any product you purchase meets all legal requirements.
