Category: Foods & Beverages
Top 5 Violations in the Latest FDA Foreign Supplier Verification Warning Letters
It’s not just the temperatures that have been sizzling as of late! FDA’s recent flurry of FSVP Warning Letters continues to demonstrate that FSVP enforcement is hot, and high! As a reminder, FSVP mandates that importers verify that their foreign suppliers meet U.S. safety standards. We will take a look here at the top five […]
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 […]
The Importance of Conducting a Regulatory “Check-Up”: Ensuring FSVP Compliance and Passing an FDA FSVP Inspection
FDA plays a critical role in safeguarding public health by enforcing regulations to ensure the safety of imported food products via routine inspections and other means. Recently, the FDA issued three warning letters to food companies for their failure to have a Foreign Supplier Verification Program (FSVP) in place. Specifically, FDA found that all three […]
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 […]
FDA Intensifies Scrutiny on Honey Amid Rising Concerns of Economic Adulteration
The FDA announced this week that honey will undergo testing for economically motivated adulteration (EMA) via import sampling and a risk-based import entry screening program. Honey, the golden nectar cherished for its natural sweetness and numerous health benefits, has been on FDA’s radar over the last few years with Agency sampling assignments carried out in […]
Implications for Food Industry and Businesses
FDA’s recent step in issuing Import Alert 99-48 for food products containing chemical contaminants has sent ripples through the food industry and businesses engaged in food production. Particularly affected are companies involved in the production of products containing per- and polyfluoroalkyl substances (PFAS) or other chemical contaminants . PFAS are a group of man-made chemicals […]
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 Showcases New Regulation Portal for Food + Cosmetics Program
In efforts to increase transparency and support stakeholders with understanding the FDA’s regulatory agenda, the Agency unveiled its new website identifying regulations that the Agency plans to publish by October 2024, and longer-term regulations the FDA is prioritizing for publication at a later date. Aimed at informing industry on “what’s ahead”, the FDA Foods Program […]
Quickly Remove Potentially Violative Product and Minimize Business Disruption and Loss
A pantry staple, granola bars and granola cereals faced a nationwide product recall just before the holidays by the Quaker Oats Company due to potential contamination with Salmonella, a high-risk bacteria that can cause fatal infections in vulnerable populations such as children, the elderly, and those with weakened immune systems. The recall affected Quaker Chewy […]
FDA Screens Incoming Shipments of Cinnamon for Lead Contamination as a Result of Recalled Apple Cinnamon Fruit Pouches.
Following additional reports of illnesses potentially linked to lead in recalled fruit and applesauce pouches, the U.S. Food and Drug Administration (FDA) announced that it is screening shipments of cinnamon from multiple countries for possible lead contamination. So far, cinnamon rolls and other cinnamon-containing products can be still by joyfully had this Thanksgiving and holiday […]
★★★★★
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.
