Category: OTC Drugs
The FTC’s July 2025 Crackdown on “Made in USA” Claims Puts Industry on Notice
A Patriotic Primer Turned Compliance Crossfire As barbecues sizzled and flags fluttered this July 4th, the Federal Trade Commission (FTC) was busy preparing a fireworks display of its own—this one of the regulatory variety. Declaring July as “Made in USA Month,” the Commission followed up its symbolic gesture with real regulatory firepower: four warning letters […]
A Look at Audit Readiness in the Age of Expanded Inspections
The FDA is back in full swing, and inspections—both scheduled and surprise—are becoming more frequent, more detailed, and more critical than ever. As global regulators expand the scope, frequency, and depth of inspections, companies face increasing pressure to demonstrate compliance and transparency. Expanded inspections, whether triggered by legislative updates, whistleblower complaints, or routine agency policy, […]
FDA Announces Expanded Use of Unannounced Foreign Inspections
In what can only be described as the regulatory equivalent of “We were in the neighborhood…”, the U.S. Food and Drug Administration (FDA) announced May 6, 2025, its expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. Yes, you read […]
Strategic Guidance for FDA-Regulated Companies
The return of Trump-era “America First” trade policies in 2025 has reshaped the regulatory and economic environment for companies regulated by the U.S. Food and Drug Administration (FDA)—particularly those in the food, cosmetics, medical device, and over-the-counter (OTC) drug sectors. With the reimposition of tariffs on key imports, intensified scrutiny of foreign manufacturing, and a […]
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 […]
The Magic of FDA Export Certificates Including New Requirements for Dairy Exports to India
U.S. FDA compliance, marketing clearance, and being in general good standing with the Agency is oftentimes the secret sauce to international markets. Foreign governments and foreign purchasers are keen to understand whether and to what extent exported goods comply first with U.S. regulatory requirements, marking a glittery stamp of approval. To help in this effort, […]
The Wild Waters of an FDA Recall
Recalls are critical for ensuring public safety when products pose health risks but for businesses, this also means reacting quickly to contain the bleeding, limit supply chain disruption and avoid business and reputation damage while simultaneously working alongside the FDA, which plays a pivotal role in managing and helping effectuate recalls – a juggle of […]
An Endurance Test of Paperwork and Patience
Welcome to the FDA import detention merry-go-round, where we say, hold onto your paperwork! The FDA import detention process can be a daunting (and let’s be honest, derailing!) experience for businesses involved in importing goods, especially those in the realm of foods, cosmetics, dietary supplements, drugs or medical devices. However, with proper knowledge and strategic […]
New Fiscal Year 2024 Rates and What You Need to Know
Last week, FDA announced the rates for over-the-counter (OTC) monograph drug facility fees for fiscal year (FY) 2024 with a noticeable 31% marked rate increase from FY 2023 rates: FY 2024 rates include $34,166 for a Monograph Drug Facility (MDF), and $22,777 for a Contract Manufacturing Organization (CMO). As a reminder, OTC monograph drug facility […]
FDA Issues Final Guidance on Updated Procedures and Timeframes
This week, the FDA announced the availability of final guidance for the dietary supplement industry regarding procedures and timeframes for premarket safety notifications, commonly referred to as new dietary ingredient notifications (NDINs). Aimed at improving the rate of compliance with the new dietary ingredient (NDI) notification requirement, the quality of NDI notifications, and ensuring the […]
★★★★★
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.
