Category: Fda compliance

According to the National Coffee Association, over 62% of Americans drink coffee daily, making it one of the country's most popular beverages. Despite its widespread consumption, many people are unaware of the regulatory framework behind their morning cup and often ask, 'Does coffee need FDA approval?'. The answer is complex, as the FDA regulates coffee differently than it would a drug, focusing on safety and labeling rather than pre-market approval.

According to the U.S. Food and Drug Administration (FDA), dietary supplements do not undergo the same pre-market approval process as pharmaceutical drugs, a key regulatory distinction often misunderstood by consumers. Instead of seeking "FDA approval," supplement companies must ensure their manufacturing facilities are registered and compliant with strict quality standards set by the FDA.