We are please to announce that our managing partner, Heather Bustos, was chosen as a 2022 Texas Rising Star by Super Lawyers. Only a few attorneys from each state are selected to Super Lawyers designation for any given year. The multi-factor selection process includes independent research, peer nominations and evaluations, as well as professional achievement in legal practice. "I am honored to receive this distinction and thankful to my colleagues for this recognition. My pas

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 compliance during law school, while working for a longtime FDA solo attorney. Though this area is rarely mentioned when listing common areas of legal practice, it is vast and constantly changing. The ability to help businesses succeed and thrive in the regulatory landscape is a joyful experience for me. The businesses BLG serves are product

Cosmetics are one of the least regulated product categories by the FDA, but that does not mean you can skip on compliance. There are still very good reasons to register even when voluntary that can greatly affect a business. One such optional program is known as the Voluntary Cosmetic Registration Program or VCRP. There are many benefits to completing this process, even though it is not a strict requirement of the Food and Drug Administration. The VCRP is broken into two par

Facilities who have not complied with paying the annual OTC Monograph User Fee Program (OMUFA) fees required under section 744M of the FD&C Act, are now publicly listed on the FDA arrears list. FDA has also stated that they "will periodically update the arrears list to reflect facility payments." If you believe that you were improperly listed, or believe you meet exemption requirements, reach out to Bustos Law Group for assistance. To download and view the list, please click

As we reported in our previous blog post, the FDA is now collecting OTC Monograph User Fees beginning May 10, 2021. These fees will apply to contract manufacturers and private labelers, but exemptions apply for hand sanitizer manufacturers who started manufacturing during the COVID-19 pandemic. Read more here: https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa Please reach out if you have questions about these fees and how they w

On March 27th, 2021, the FDA released the new OTC Monograph Facility Fees. New fees are due on May 10th, 2021.

Imagine an armband that, combined with special software, can tell you whether there is coagulation in the blood of a patient within 3-5 minutes of being worn? That technology may be here sooner than we think. “The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions,

"FDA has taken action to place all alcohol-based hand sanitizers from Mexico on import alert to help prevent entry of violative and potentially dangerous products into U.S. - protect U.S. consumers" Have questions about how this will impact you? Reach out to Bustos Law Group for a free consultation with one of our regulatory attorneys. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-place-all-alcohol-based-hand-sanitizers-mexic

The Food and Drug Administration (FDA) announced last week the fee rates under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. The federal register notice was released December 29th, 2020 with the new rates listed. Qualifying facilities FDA will assess and collect facility fees with respect to the two types of OTC monograph drug facilities—MDF and CMO facilities. A full facility fee will be assessed to each qualifying person that owns a f

There is a consensus that the Food and Drug Administration (FDA) is rushing the decision to “approve” Pfizers Covid-19 vaccine. Before rushing to that conclusion, let’s understand the FDA’s vaccine approval process at a glance. Firstly, it is important to note that even though the Pfizer vaccine was 95% effective at preventing cases of COVID-19 in both Latinos and non-Latinos, 100% effective in Black people, 94% effective in people who were at least 56 years old, 95% effectiv

The FDA has provided several updates regarding its ongoing response effort to the covid-19 pandemic. Included, was an update regarding the number of authorized tests to date: “As of today, 288 tests are authorized by the FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.” For the full November Covid-19 Update, click on the following link: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-november-16-2020

In case you missed it, the FDA has now shifted course (as anticipated) and removed the availability of the EUA (Emergency Use Authorization) pathway for filtering facepiece respirators manufactured in China. When COVID-19 first began making its way around the world, the FDA acted quickly to allow PPE (personal protective equipment) into the market to boost supply. However, much of the industry understood that this would not last long. As manufacturers and distributors submit

The FDA's CDRH issued guidance, effective immediately, detailing new requirements for medical device manufacturers to notify it of shortages

Did your hand sanitizer come inside of a beer can? is it chocolate scented? FDA has begun receiving reports of hand sanitizers packaged as baby food or beverages. In response, the FDA commissioner Stephen M. Hahn stated “Manufacturers should be vigilant packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers. The FDA continues to monitor these products and we’ll take appropriate actions as nee

The article titled: A [Texan] COVID Success Story discusses the rise of Texas oil and gas companies moving into the hand sanitizer industry in response to the COVID-19 pandemic . To learn more about the shift, find the article link here: https://issuu.com/leosur/docs/thl_julaug20/46 Full issue: https://www.thehoustonlawyer.com (page 46-47)

On August 5th, our firm partner, Heather Bustos, spoke at a webinar hosted by the Houston Indonesian Consulate. She went through the basics of FDA food compliance requirements. She reviewed everything from labeling and registration to Current Good Manufacturing Practices and COVID-19 updates. She joined other speakers on Indonesian exports and food compliance which included one of BLG's clients. Heather assisted Asnul with compliance of his Indonesian food products back in 20

The FDA has released a list of over 100 products that either contain methanol, have less than the required amount of ethyl or isopropyl alcohol. It also includes manufacturers who have products in the same facility as products that have been tested and found to contain methanol. Manufacturers should be weary of these issues and have quality procedures in place to avoid them. Distributors should ensure that they properly vet the sources of their products or manufacturers to en

During this pandemic, hand sanitizer has become a vital. household product to have “on hand”(excuse the pun). This has inspired many entrepreneurs, small businesses, and even large corporations, to jump into the manufacturing and distribution game. This, combined with the FDA’ Emergency Use Authorization for hand sanitizers, has allowed hand sanitizer to become more available and boosted supply. But there is a big risk in opening the gates. The quantity is increasing while th

Guided by their scientific findings, the FDA has removed Hydroxychloroquine and Chloroquine from the FDA emergency authorization citing “ineffectiveness”. Once thought to be an effective treatment for Covid-19, scientist have found that the malaria fighting drugs “showed no benefit on mortality or in a speedy recovery” during clinical trials. Acting director Patrizia Cavazzoni, M.D closed the announcement by reiterating that “We (FDA) remain committed to using every tool at o