Posts by Marc Sanchez
FSMA Inspections
FSMA inspections are well underway. The Food Safety Modernization Act (FSMA) is slowly beginning to roll out. The implementation is a learning curve both for industry and the FDA. Still there have been dozens of inspections. FDA Atty completed a Freedom of Information Act (FOIA) request with the FDA’s Center for Food Safety and Nutrition…
Read MoreWhat represents an FDA Consent Decree?
An FDA Consent Decree represents a serious step in FDA enforcement. To obtain a consent decree the FDA must work with the Department of Justice (DOJ) trial attorney to file a complaint in Federal District Court. This type of filing requires a response otherwise a default judgment will be entered against the defendant facility. In…
Read MoreFDA Amazon 2017
FDA Amazon 2017
Read MoreVET Permit Gelatin
Is Vape Doomed?
As state bans begin to join major city bans and the FDA announcement of a new crackdown the question many people are asking is vape doomed? There’s no question vape (e-cigarette, e-liquids, ENDS hardware, etc.) faces an uphill battle at both the state and federal level here are some reasons it may continue albeit in…
Read MoreEmerging Growth Companies
Our firm offers works with companies of all sizes and at all different stages of growth. Emerging growth companies in regulated industry can need special guidance on corporate matters. Issues ranging from formation, questions about investing regulations, distribution agreements and agreements with contract manufacturers. We can discuss a broad range of corporate issues and develop…
Read MoreSNAP Trafficking Charge Letter
Overview of USDA/FNS Charge Letter Response and Appeal SNAP Trafficking charge letter act as the official notification from the USDA FNS (United States Department of Agriculture Food and Nutrition Service) to a SNAP retailer. It will indicate the nature of the trafficking violations, the time-frame to respond, which is incredibly short, and the type of…
Read MoreFDA Form 483 Response Strategy – FY 2012 Inspectional Observation Summaries
FY 2012 Inspectional Observation Summaries FDA Form 483 response strategy – perhaps the best strategy to both prepare for a
Read MoreListing of Ingredients in Tobacco Products
Listing of ingredients in tobacco products will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). The listing of ingredients must be submitted using the FDA’s Electronic Submission Gateway (ESG). The ingredient listings are due on one of two deadlines depending on the scale of operations. Those are…
Read MoreTobacco Health Certificate (NCTTP)
The tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). These certificates must be submitted using the FDA’s Electronic Submission Gateway (ESG). Health certificates are due on one of two deadlines depending on the scale of operations. These are February 8, 2017, or August…
Read MoreWalmart VTA Supplier Requirements
Selling with a major retailer is a dream for many companies. When selling with any major retailer it is important to understand the retailer’s regulatory requirements. Walmart VTA supplier requirements (vendor tagged advertisement) is one example. This process is sued by Walmart to approve or reject any radio or TV advertisements for its vendor’s products.…
Read MoreAmazon FDA Registration Proof
Amazon FDA registration proof can be a moving target. Is it a certificate, a screenshot, or something else!? The answer varies from week to week and from seller support agent to seller support agent. Amazon FDA registration proof is something this blog has tackled on numerous occasions. Over the past six months, I’ve been working…
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