Posts by Marc Sanchez
FDA Cosmetic Safety and Modernization Act (S2003)
Yesterday, October 2, 2018, Senator Orrin Hatch introduced the FDA Cosmetic Safety and Modernization Act (S2003). The proposed bill, like many of its predecessors, including Personal Care Products Safety Act (S.1113) and Cosmetic Modernization Amendments of 2017 bill (H.R. 575), would fundamentally change the cosmetic industry. Senator Hatch’s FDA Cosmetic Safety and Modernization Act (S2003) includes familiar changes like…
Read MoreFDA Microneedling Guidance
FDA microneedling guidance at long last arrived today (Sept. 14, 2018). The Draft Guidance document is available here. Previous posts on microneedling can be found here and here. Only a summary of the microneedling guidance posted today. Below is the constituent update announcing the release. As expected it appears the FDA will propose a two pronged approach…
Read MoreMedical Device User Fee Rates for Fiscal Year 2018
The US FDA announced Medical Device User Fee Rates for Fiscal Year 2018 on Monday morning (August 28, 2017). The Medical Device User Fee Rates for Fiscal Year 2018 will impact the annual registration fee along with a number of submissions. For FY18, the registration fee for each establishment is $4,631 (in U.S. Dollars). All establishments that are…
Read MoreRegulatory Mediator
Mediation is an increasingly used tool both by courts and parties to avoid litigation. When a dispute involves regulatory issues, such as FDA compliance questions, a regulatory mediator can help parties reach a resolution without spending valuable time educating a mediator about the regulations. Common regulatory disputes involve Lanham Act for unfair trade practices, trademark…
Read MoreInterview on AME Food Testing Show
My Interview on Whether FSMA will Require Food Producers to Test their Products <object classid=”clsid:D27CDB6E-AE6D-11cf-96B8-444553540000″ codebase=’http://download.adobe.com/pub/shockwave/cabs/flash/swflash.cab#version=9,0,0,0′ width=’210′ height=’105′ name=”214821″ id=”214821″><param name=”movie” value=”http://www.blogtalkradio.com/btrplayer.swf?file=http%3A%2F%2Fwww.blogtalkradio.com%2Fame-foodtestingshow%2F2011%2F11%2F09%2Fwill-fsma-require-food-producers-to-test-their-products%2Fplaylist.xml&autostart=false&bufferlength=5&volume=80&corner=rounded&callback=http://www.blogtalkradio.com/flashplayercallback.aspx” /><param name=”quality” value=”high” /><param name=”wmode” value=”transparent” /><param name=”menu” value=”false” /><param name=”allowScriptAccess” value=”always” /><embed src=”http://www.blogtalkradio.com/btrplayer.swf” flashvars=”file=http%3A%2F%2Fwww.blogtalkradio.com%2Fame-foodtestingshow%2F2011%2F11%2F09%2Fwill-fsma-require-food-producers-to-test-their-products%2fplaylist.xml&autostart=false&shuffle=false&callback=http://www.blogtalkradio.com/FlashPlayerCallback.aspx&width=210&height=105&volume=80&corner=rounded” width=”210″ height=”105″ type=”application/x-shockwave-flash” pluginspage=”http://www.macromedia.com/go/getflashplayer” quality=”high” wmode=”transparent” menu=”false” name=”214821″ id=”214821″ allowScriptAccess=”always”></embed></object><div style=”font-size: 10px;text-align: center; width:220px;”> Listen to <a href=”http://www.blogtalkradio.com”>internet…
Read MoreFDA Textbook by Springer International; Release Date Annouced
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…
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