Bustos Law Group, PLLC

Bustos Law Group, PLLC We are an FDA compliance firm empowering mission-driven businesses in the health, wellness, and beauty industries to thrive within the regulatory landscape.

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

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

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

The FDA’s spotlight is officially on the cosmetics industry, and thanks to MoCRA, “serious adverse event reporting” isn’...
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...

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

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