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Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.

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End-of-Year Recap: 2023 Recall Trends and Projections for 2024/2025

As 2024 concludes, it’s time to reflect on the key trends that defined the year in product recalls and consider how 2024 is shaping up….

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FDA Influencer Marketing Guide for Compliance

Navigating the complex landscape of FDA advertising guidelines is crucial for food and drug companies looking to leverage the power of influencer marketing while staying…

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US Supreme Court Hears Flavored Vape Case: Key Takeaways for Industry Stakeholders

The U.S. Supreme Court heard oral arguments on Monday in Wages and White Lion Investments. The Court heard arguments regarding the FDA’s defense of refusing…

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Nicotine Pouches and FDA Regulations

Nicotine pouches have gained popularity as an alternative to smoking. Here, we will guide you through the FDA regulations surrounding nicotine pouches.

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Regulatory Attorneys vs Consultants: The Right Choice for You

Understanding the roles of regulatory consultants and attorneys is crucial when bringing a product into the market. Here, we will showcase their differences.

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Confidently Responding to a 510(k) FDA Deficiency Letter

Not sure how to handle an FDA deficiency letter? This guide outlines steps to confidently respond and get your product cleared for market.

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Importing FDA Regulated Products for the Holidays in 2024

The holiday season is a peak time for businesses importing goods into the United States. However, when these goods are regulated by the FDA, there…

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Listeria Outbreak Difference Between Deli Meat and Cantaloupes

As has been widely reported, Boar’s Head issued a recall in late July for more than 7.2 million pounds of its ready-to-eat liverwurst and some…

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FDA Tobacco Submission Tracking Number Import Requirement

New FDA and Treasury Rule Proposes Streamlined Import Process for E-Cigarettes In an important step toward regulating the import of Electronic Nicotine Delivery System (ENDS)…

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FDA Plans to Launch Updated Submission Portal for New Tobacco Product Applications in 2025

The FDA’s Center for Tobacco Products (CTP) has announced its plans to unveil the CTP Portal Next Generation (“CTP Portal NG”) in 2025, an improved…

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Supreme Court Agrees to Hear Case Challenging FDA’s Vape Regulation

Supreme Court Grants FDA’s Petition for Certiorari in Wages and White Lion Investments v. Food & Drug Administration In a significant move that could reshape…

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The Impact of the Supreme Court Striking Down Chevron on FDA Regulation

As has been widely reported today, the United States Supreme Court overturned a 40-year old precdent known as the Chevron Doctrine. There are excellent write-ups…

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