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Category: OTC Drugs

Celebrating Valentine’s Day with Aromatherapy Products or “Love” as an Ingredient in your Granola?

02/13/2024

A Quick Look at FDA’s Regulation of Cosmetics vs. OTC Drugs and FDA-Approved Ingredients

As you lovingly purchase essential oils and aromatherapy products for your Valentine or add a sprinkle of “love” in their breakfast food this Valentine’s Day, you may want to double check that these products are FDA compliant! Under FDA regulations, fragrance products such as essential oils that are marketed with aromatherapy claims that they will […]

FDA Issues Eyedrops Products Warning

11/02/2023

FDA Issues Warning to Avoid Purchase or Use of 26 Eyedrops Products from Several Major Brands due to Risk of Eye Infection

Protecting Your Sunny Side Up

06/06/2023

A Look at FDA’s Regulation of Sunscreen FDA has regulated sunscreen since the 1970s to ensure that consumers have access to safe and effective sun protection products, but not all sunscreens are created equally! As there have been several developments involving sunscreen regulation in the past few years, we’ll provide an update as to where […]

In Case You Haven’t Heard

05/10/2023

FDA’s Regulation of OTC Hearing Aids vs. PSAPs Last fall, FDA released its final rule establishing a regulatory category for Over-the-Counter (OTC) hearing aids, pursuant to FDA’s Reauthorization Act of 2017. The agency’s final rule allows adults ages 18 and older with perceived mild to moderate hearing loss to purchase air conduction hearing aids without […]

Is My Hand Sanitizer a Food? A Cosmetic?

04/21/2023

No! FDA Reminds Consumers that Hand Sanitizers are Regulated as Over-the-Counter Drugs With new marketing of hand sanitizers touting food flavors or fragrances, FDA recently issued a consumer notice, reminding consumers that the FDA regulates hand sanitizers as Over-the-Counter (OTC or non-prescription) drugs. Companies may market OTC drugs in the U.S. without FDA clearance, […]

OTC Drug Reform & The CARES Act

04/12/2023

FDA Issues Draft Guidance on Format and Content of OMOR Submissions: OTC Drug Reform and The CARES Act This week, FDA announced that it issued a draft guidance for industry on the format and content for Over-the-Counter Monograph Order Requests (OMOR), aimed at establishing or changing conditions for an OTC drug. The draft guidance is […]

FDA Roundup: The Latest Activity

03/31/2023

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 […]

FDA Roundup: A Look at the Latest FDA Activity

03/09/2023

What you Need to Know about FDA Device Regulation

02/08/2023

Marketing Sunglasses, Bandages, Hospital Equipment, Pregnancy Test Kits, Cosmetic Devices, Personal Lubricants and More The U.S. leads the world in medical innovation and is the largest consumer of medical devices in the world. We use medical devices daily, whether it is throwing on a pair of sunglasses, hitting the ski slopes with a pair of […]

How to Prepare and Execute an FDA Regulated Recall

01/19/2023

Protecting Consumers, Limiting Supply Chain Disruption and Avoiding Business and Reputation Damage Quickly and Effectively With product recalls consistently being in the news over undeclared allergens, bacterial contamination, physical hazards, potential of a product’s failure to conform to a performance standard, and many other reasons, consumer’s health and safety are naturally at stake. Companies also […]

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R.G. Client

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.

Mike H. Client

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.

Dr. Sastry Client

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.

Claire P. Client