Tag: New dietary ingredient

The US dietary supplement market exceeded $53 billion in 2023, yet a core challenge for consumers and manufacturers remains: understanding the complex regulatory framework. So, how are nutraceuticals regulated in the US, and what key laws govern their safety and marketing?

According to the FDA, dietary supplements are regulated as a category of food, not as drugs, which fundamentally changes the way the agency oversees them. This key distinction helps explain why the FDA does not approve dietary supplements before they are sold to the public, and clarifies what are FDA supplements in the context of federal law.

More than 10 dietary supplement companies have received FDA warning letters for including hordenine in their products, an ingredient the agency deems "adulterated". For anyone prioritizing a safe and effective nutrition diet, understanding why is hordenine banned is crucial to avoiding potentially harmful and unregulated stimulants.