Bustos Law Group

A medical device startup invested two years and $2 million developing an innovative Class II diagnostic tool. They believed their 510(k) submission was airtight, relying on a consultant who promised a quick path to market. Instead, the FDA issued an Additional Information (AI) request, citing inadequate clinical data and poorly defined intended use statements. The launch was delayed by nine months, investor funding dried up, and a competitor beat them to market. This catastrophic scenario is...

Many supplement brands believe that using natural or organic ingredients shields them from strict FDA oversight. This misconception has led to hundreds of enforcement actions, devastating financial penalties, and irreversible brand damage. A common pitfall is the inadvertent promotion of "off-label use," where a product is marketed for a purpose beyond its substantiated structure/function claims. When a brand implies its supplement can cure, treat, or prevent a disease, it crosses a dangerous...

The FDA issued 847 Warning Letters in 2024, with many companies facing enforcement actions simply because they misunderstood the strict requirements of Title 21 CFR. For food and beverage brands, the consequences of regulatory ignorance are severe. A single violation can lead to a 15-day response deadline, product seizures, or a mandatory recall. This is not a hypothetical risk; it is a daily reality for companies that fail to align their operations with FDA regulations. Title 21 of the Code...