Tag: FDA News
Cosmetic Facility Registration, Product Listing, Record-Keeping, Recall Readiness, and Labeling and Substantiation Compliance for Lasting Radiance Hear ye hear ye! Implementation deadlines and compliance dates for the new Modernization of Cosmetic Regulation Act (MoCRA) requirements, aimed at strengthening FDA’s regulation of cosmetic product safety in over 80 years, are around the corner. And we must […]
You import a product to the U.S. and then receive a notice from your customs broker that the shipment has been held by the FDA. Next, you receive a Notice of FDA Detention right when you are about to fulfill a huge Purchase Order. Now what? Is the shipment lost in FDA space or can […]
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 […]
A Look at FDA’s Enforcement Policy on Major Food Allergen Labeling and Cross-Contact
Update to FDA’s Enforcement Policy on Major Food Allergen Labeling and Cross-Contact As FDA recalls related to allergen labeling continue to abound, and as the agency continues to receive reports of consumers who experienced adverse reactions following exposure to an allergenic substance in foods, FDA provided a much-needed update with its issuance of an updated […]
How to Comply with USDA Requirements for Animal and Plant-Derived Products, and Avoid Import Holds and Enforcement Action Imported orchid extract in shampoos, chicken broth in pre-packaged soup, fish oil in supplements, seeds for planting, seeds for research use only, and vitamins and minerals derived from bovine and ovine origin surprisingly have a common thread. […]
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 […]
Ongoing Scrutiny Over Kratom: Challenges as a Bulk Dietary Ingredient and as a Dietary Supplement FDA recently seized more than 250,000 units of dietary supplements and bulk dietary ingredients that are or contain kratom (also known as mitragyna speciosa, a tropical tree native to Southeast Asia, commonly used for its leaves). The dietary supplements, manufactured […]
Belgian authorities destroy American beer for failure to comply with Protected Designation of Champagne: A look at Parallel Market Imports and Food Standards and Labeling Last week, Belgian authorities destroyed more than 2,000 cans of Miller High Life at the request of the Comité Champagne, a trade organization that oversees use of the name Champagne, […]
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, […]
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 […]
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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.
