FDA News

For regulated businesses, product safety, quality, and efficacy are paramount. A single training gap can lead to production errors, regulatory violations, and even product recalls. FDA compliance training is not just a box to check; it is a critical investment in your company’s success and a legal requirement. This guide explains what the FDA requires, who needs training, and how to develop a program that withstands regulatory scrutiny. Why FDA Compliance Training Matters FDA

A food label is a promise to your customers. It builds trust and communicates your commitment to quality.  But a single labeling mistake can break that trust, trigger an FDA inspection, or lead to a costly recall. For food businesses in the USA, understanding FDA food labeling requirements is essential to protecting your brand and your customers. This guide explains the core requirements for food labels , how to avoid common mistakes, and what to expect from new FDA regulatio

For regulated businesses, product safety, quality, and efficacy are paramount.  A single training gap can lead to production errors, regulatory violations, and even product recalls. FDA compliance training is not just a box to check; it is a critical investment in your company’s success and a legal requirement.  This guide explains what FDA requires, who needs training, and how to build a program that stands up to regulatory scrutiny. TL;DR: FDA compliance training is a legal

An FDA inspector arrives at your facility. For a prepared business, this is a chance to shine. For the unprepared, it can be a regulatory nightmare. FDA compliance checks are a fact of life for regulated industries.  This guide provides a playbook for how to prepare for, manage, and respond to FDA inspections. TL;DR FDA inspections are unannounced. The key to success is a constant state of readiness, not last-minute cramming. Your documentation should tell a coherent story o

When the FDA arrives, it’s a different ballgame than what you learned in compliance courses. Standard training provides the rulebook but overlooks the unwritten elements, including the strategic and psychological aspects that make or break an inspection. Preparing for the FDA doesn’t have to be a frantic scramble. By embracing a culture of readiness, you can face your next inspection with confidence. Here are 7 practical tips that compliance courses often overlook. 1. Tell a

Regulatory Compliance Attorney vs General Business Lawyer: these titles may sound similar, but they serve very different purposes for your business. If your challenge is about laws, government rules, or avoiding fines, a regulatory compliance attorney in Texas is the expert you need. But if you're focused on contracts, deals, or company growth, a general business lawyer will guide you through the legal side of building your business. Understanding the difference between a Tex

Structure/function claims provide a clear understanding of what a supplement can do for your body. These claims explain how vitamins, minerals, probiotics, or herbal supplements support normal health without claiming to treat or cure diseases.  Every claim must follow FDA food-safety rules, include a disclaimer, and be backed with scientific proof from reliable sources such as the National Institutes of Health. Understanding the difference between structure/function claims an

Receiving an FDA warning letter can be a daunting experience for any business. This official notice signals significant violations that demand immediate attention. The worst part is that this notice becomes public on the agency's website and worse can be picked up by media. So, what should you do if your business faces this challenge? First things first, don’t panic. Here’s a comprehensive guide to navigate this situation effectively.  Identifying and Addressing Common FDA C

Imagine this: You’re in the middle of a busy workday, juggling emails and meetings, when suddenly, you get the call. The FDA is at your...

Today is Election Day and most of us are nervously biting our nails while awaiting the results. Some because it could affect their legal...

Starting your own small business can be hard work, but extremely rewarding. Add a major governmental agency like the FDA into the mix and...

The Woodlands, Texas, August 19, 2022 (GLOBE NEWSWIRE) – Heather M. Bustos, Esq., Partner at FDA compliance firm, Bustos Law Group, has been selected by Best Lawyers for its 2023 “Best Lawyers: Ones to Watch” award. Bustos, an FDA compliance attorney, has previously been recognized by Super Lawyers Texas Rising Stars in 2022, as well as Marquis Who’s Who in America, in 2022. Best Lawyers “Ones to Watch” awards are recognitions given to attorneys for outstanding professiona

Discovering a new ingredient for a dietary supplement can be exciting. Not only is there a possibility of the ingredient helping...

Guided by their scientific findings, the FDA has removed Hydroxychloroquine and Chloroquine from the FDA emergency authorization citing...

Today the Food and Drug Administration (FDA) released a list of 1,003 class II medical devices that it believes do not require premarket...

Earlier this month, on August 4th, the FDA issued Amazon a warning letter beginning, “ This letter concerns your firm’s distribution of...

Partner, Heather Bustos, Selected as 2022 Texas Rising Star by Super Lawyers. We are pleased to announce that our managing partner,...

If you are the parent of a newborn or infant in 2021, you most likely know about all the innovative new tech gadgets coming to market for child monitoring. One of the most popular new products on the market currently is the Owlet Smart Sock. The smart sock is intended to monitor blood oxygen levels as well as heart rate and alert parents if these measurements go out of range. According to the FDA, the company has been marketing their Owlet Smart Sock product without premarke

A Note From Our Partner: Starting Bustos Law Group was always a dream of mine. I was fortunate enough to be introduced to the area of FDA...

The Food and Drug Administration (FDA) announced last week the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program...