Bustos Law Group, PLLC

01/06/2026

The FDA’s updated MoCRA timelines are a clear signal that cosmetic enforcement is gaining speed.

Fragrance allergen labeling, formaldehyde restrictions, and GMP requirements are all taking shape. For beauty brands, this is the time to tighten supplier documentation, ingredient transparency, and internal compliance calendars.

In her latest article, managing partner Heather Bustos explains how MoCRA will change cosmetic regulation, which deadlines to prioritize, and what actions brands should take before final rules are released.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant change to United States cosmetics regulation in eighty years. Over the past two months, the FDA has updated its implementation timelines, and beauty brands need to pay close attention.

01/02/2026

Congress is revisiting the approval process for food ingredients, and it could alter the GRAS system as we know it.

The Better Food Disclosure Act aims to end self-affirmed GRAS determinations and require all safety conclusions to be reviewed and made public by the FDA. For food manufacturers and suppliers, this is a potential game-changer that could introduce new layers of documentation, disclosure, and oversight.

This article from managing partner Heather Bustos covers what the proposed bill means, what companies should be doing now, and how to prepare before it becomes law.

The food industry has depended on the self-affirmed GRAS pathway for decades. It has allowed companies to determine that an ingredient is Generally Recognized as Safe and bring it to market without submitting the evaluation to the FDA.

12/30/2025

The FDA is expanding enforcement against unapproved blood pressure monitors and wearable devices that claim to measure medical conditions.

Many products marketed as consumer health tools actually fall under the medical device classification and require 510(k) clearance. Companies that miss this distinction risk warning letters, inspections, and removal from major platforms.

Managing partner Heather Bustos breaks down what the FDA’s latest safety communication means, how to determine if your device qualifies as a regulated product, and what compliance steps to take now.

The FDA’s recent safety communication on over-the-counter blood pressure monitors and wearable devices is one of the most significant enforcement signals the device industry has seen in years. Smartwatches, rings, wristbands, and connected devices have flooded the consumer health tech market.

12/26/2025

The FDA’s spotlight is officially on the cosmetics industry, and thanks to MoCRA, “serious adverse event reporting” isn’t optional anymore.

Brands that ignore these requirements risk recalls, registration suspensions, and major reputational damage.

Heather Bustos, our managing partner, breaks down exactly what counts as a “serious” event, who’s responsible for reporting, and what every brand needs to have in place before the FDA comes knocking.

Read the full breakdown below.

The cosmetics industry is officially under the FDA’s microscope — and if you’re a brand owner, manufacturer, or distributor, the time to get serious about adverse event reporting is now. Thanks to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetic products are no longer fl...

12/23/2025

With RFK Jr. now leading HHS, the supplement industry is heading into uncharted territory, and our managing partner, Heather Bustos, has thoughts.

In her latest article, Heather unpacks what the “Make America Healthy Again” (MAHA) agenda could mean for supplement makers: looser regulations, expanded health claims, and a push for transparency that could reshape the entire market.

What’s opportunity for some may be compliance chaos for others.

Catch up on what’s changing in the article below.

If you’re in the dietary supplement industry, you’ve probably noticed the winds shifting — and fast. With Robert F.

12/20/2025

California is once again rewriting the playbook — banning Red Dye No. 3, cracking down on PFAS, and rolling out aggressive packaging reform deadlines.

Heather Bustos, our managing partner, explains why these state-level laws will soon have national impact and what food brands should be doing now to reformulate, relabel, and rethink packaging before enforcement hits.

Read Heather’s full legal insight in the article below.

11/05/2025

Big changes are coming for medical device manufacturers.

By February 2026, the FDA will officially align its Quality Management System Regulation with ISO 13485, and managing partner Heather Bustos is walking companies through what this means for compliance, documentation, and global market access.

Don’t wait until 2026 to get ready.

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If you're in the medical device space, you've likely heard the buzz: the FDA is officially aligning its Quality Management System Regulation (QMSR) with ISO 13485:2016. This is a big deal — and it’s not just regulatory housekeeping.

10/30/2025

Beauty / Cosmetic brands, Did you miss our last webinar? This fireside chat answers the crucial question: How do you support your beauty claims with data that stands up to legal scrutiny?
Join Heather Bustos (Bustos Law Group) and Suzanne Mickey (Citrus Labs CEO) to learn the science behind true regulatory compliance.

Check it on our youtube channel, and don't forget to like and subscribe if you found it valuable! We post new videos every week aimed at educating you on all things FDA regulatory compliance.

https://youtu.be/pTPhwS4WtHs

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This fireside chat answers the crucial question: How do you support your beauty claims with data that stands up to legal scrutiny? Join Heather Bustos (Busto...

10/01/2025

In the world of dietary supplements, outsourcing manufacturing is common, but compliance can't be outsourced.

Our latest post breaks down what brand owners must do to stay on the right side of FDA regulations when working with contract manufacturers.

From auditing partners to establishing product specs and SOPs, we cover the key steps to protect your brand and meet 21 CFR Part 111 requirements.

Whether you're new to supplement compliance or need a refresher, this article is a must-read.

Introduction In the dietary supplement industry, outsourcing manufacturing is common—but it doesn’t absolve brand owners of regulatory responsibility. The FDA holds brand owners accountable for ensuring that products manufactured by third parties meet all applicable requirements, especially thos...

09/28/2025

🎉 Exciting News! 🎉

Please join us in congratulating Heather Bustos, Managing Partner and Founder of Bustos Law Group, on being named a 2025 Texas Rising Star by Super Lawyers!

This prestigious honor is awarded to only 2.5% of attorneys in Texas and recognizes Heather’s outstanding work in regulatory compliance law and her dedication to supporting purpose-driven brands in the health, wellness, and beauty industries.

👏 We’re proud to see Heather’s leadership and impact recognized at the state level.

09/10/2025

Is Your Wellness Product Actually a Medical Device?

The FDA’s General Wellness Guidance draws a fine line between lifestyle products and regulated medical devices, and crossing it can lead to enforcement.

In our latest article, we break down what qualifies as a general wellness device, share real-world examples, and highlight a recent FDA warning that’s a must-read for wearable tech brands.

Read the full article here:

Introduction Not every product that promotes health is exempt from FDA regulation. The agency’s General Wellness Guidance outlines what qualifies as a low-risk wellness device—and what crosses the line into regulated medical device territory.

09/08/2025

With the FDA’s expanded authority under the Modernization of Cosmetics Regulation Act (MoCRA), cosmetic companies now face stricter requirements for reporting serious adverse events. From timely submissions to recordkeeping and label documentation, compliance is no longer optional—it's essential.

In this article, we break down what brand owners and legal teams need to understand to stay ahead.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in a new era of accountability and transparency in the cosmetics industry. For the first time, cosmetic manufacturers, packers, and distributors are required to report serious adverse events to the FDA.