Tag: Imports
Navigating USDA Permits for FDA-Regulated Products
What do seeds imported for planting, chicken broth in an imported soup, or vitamins and minerals derived from animal origin materials intended for use in a dietary supplement have in common, you ask? They may all be jointly regulated by USDA and FDA! USDA (US Department of Agriculture) and FDA (Food and Drug Administration) regulations […]
Navigating FDA’s Complex Regulation of Homeopathic and Ayurvedic Products
In an era where natural and alternative medicines continue to gain traction driven by a growing interest in holistic and natural health alternatives, the U.S. Food and Drug Administration (FDA) finds itself at the intersection of tradition and science. Homeopathic and ayurvedic products, rooted in centuries-old practices, have become a sizeable industry in the United […]
The U.S. Food and Drug Administration (FDA) has announced its new medical device user fees for fiscal year 2025, effective October 1, 2024, highlighting significant updates aimed at strengthening regulatory oversight and ensuring the safety and efficacy of medical devices. The FDA’s user fee program is designed to generate necessary resources for the agency’s regulatory […]
Countdown to Cosmetics Compliance and the Upcoming Deadline
As the July 1 st deadline for compliance with the Modernization of Cosmetics Regulation Act (MoCRA) rapidly approaches, cosmetic companies are glamorously gearing up to meet the new regulatory requirements set forth by this landmark legislation. As a reminder, MoCRA represents a significant overhaul of the regulatory framework governing the cosmetics industry, ushering in a […]
In the story of “Ali Baba and the Forty Thieves” from The Arabian Nights, the phrase “Open Sesame” magically opens the mouth of a cave in which the Forty Thieves have hidden their plundered treasure. And now FDA is opening up discussion with industry regarding sesame regulations as the ninth major food allergen after observing practices involving […]
How to Avoid and Mitigate U.S. Customs Liquidated Damages and Penalties Did you know that U.S. Customs can assess penalties up to 3x the value of goods if you fail to export or destroy FDA refused merchandise timely? On top of FDA compliance concerns associated with FDA detained and ultimately refused goods, numerous other costs […]
This week, FDA kicked-off a new resource about the Modernization of Cosmetics Regulation Act of 2002 (MoCRA) and a follow-up constituent advisory that FDA has stopped accepting and processing submissions to the Voluntary Cosmetic Registration Program (VCRP). FDA is developing a program for submission of the facility registrations and product listings required by MoCRA which […]
Over the years, FDA has issued a number of Import Alerts across various FDA product categories.
Over the years, FDA has issued a number of Import Alerts across various FDA product categories. No issue and no product is off limits. Import Alerts have targeted firms that have not met dietary supplement GMPs, firms that promote unapproved new drugs in the U.S., firms that distribute devices without FDA clearance or approval, and […]
Import surveillance for Cosmetic Products
Representing a spike in enforcement, FDA reported 178 import refusals for cosmetic products in August 2022 alone. FDA refused various cosmetic products including eyelash, eyeshadow, and eyebrow products, skincare preparation products, hair preparation products, and deodorant products, on grounds that products appeared to contain unsafe color additives and were adulterated, lacked proper labeling of the […]
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Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
