Posts by Marc Sanchez
FDA Exemption to E-Cigarette Deeming Rule
***UPDATE December 16, 2016*** The draft text of the Omnibus Bill does not include the FDA exemption to e-cigarette deeming rule. If this is confirmed, then the rule will go into effect as originally planned. A potential FDA exemption to the E-Cigarette Deeming Rule may pass Congress before the end of 2015. A rider has…
Read MoreFDA Picamilon Status
In the FDA’s most recent set of warning letters Picamilon noticeably stood out with five (5) firms receiving a FDA Warning Letter on the same day. The FDA Picamilon status is now clear – it is not an approved dietary ingredient. In each FDA Warning Letter the ingredient is described as: This ingredient is also…
Read MoreCriminal Charges USPlabs LLC
Breaking News – Criminal Charges USPlabs LLC The US Department of Justice and the Food and Drug Administration announced criminal charges and other civil charges. The criminal charges will be against USPlabs and its corporate officers – a stinging reminder of the broad personal liability under the Food Drug and Cosmetic Act. The announcement highlights an intensified…
Read MoreFDA Holiday Imports
The time is fast approaching where US shoppers will begin their holiday shopping. FDA holiday imports are a common feature of the holiday season in particular speciality foods imported from across the globe. FDA holiday imports are unique because the timing is absolutely crucial. An import delay or refusal could lead to a costly missed…
Read MoreNew FDA Automatic Destruction Rule
Under New Authority Re-Export Option May be Removed An ominous sounding new rule goes into effect tomorrow (October 15, 2015). The rule is titled, “Administrative Destruction of Certain Drugs Refused Admission to the United States. Final rule.” This may be one scenario where the rule is as ominous as the title suggests. Under the new…
Read MoreFDA Criminal Liability – PCA and the DOJ Yates’ Memo
Peanut Corporation of America executives Stewart Parnell and Michael Parnell were sentenced yesterday following a conviction last year for their role in the salmonella outbreak linked to their tainted plant (click here for media coverage). Stewart Parnell will spend 28 years in jail while his brother Michael will spend 20 years. The family owned company based…
Read MoreFDA Shutdown – Preparing for the Likely Government Shutdown
***UPDATE: Congress approved a short term budget deal that will fund the government through December 11th. There remains a liklihood that a FDA shutdown could occur if a deal is not reached before then. The final quarter of the year will likely experience a rush to submit filings to the FDA in anticipation of a…
Read MoreFDA Warning for Kim Kardashian
A Lesson in paid and un-paid user testimonials It is a bit of a surprise to write about Kim Kardashian on a FDA regulatory blog. For clients it is often equally surprising to discover the FDA monitors and enforces social media posts among other mediums of marketing. If you are one of Mrs. Kardashian’s 42…
Read MoreRegulatory Planning for FDA FY 2016
The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1 through September 30. The new FY brings fee increases, expiration of registrations and statuses like the Small Business Decision, and a call for registration renewals. Regulatory Planning for FDA FY 2016 varies depending on if you are…
Read MoreFDA Microneedling Regulations Status Update
Befuddled and Confused – Microneedling and the FDA One of the most common questions received in our office is whether a product is “FDA Approved.” As microneedling grows in popularity this question is being asked about manual and motorized derma rollers as well. The question comes amid a confusing backdrop of events where Warning Letters…
Read More510k Exempt Medical Device Guidance
510k Exempt Medical Device Guidance New Guidance Expands Class I and II Exemption to Devices Previously “Unclassified” or “Reserved” New 510 Exempt medical device Guidance was issued on July 1 by the US Food and Drug Administration. Prior to the 510k exempt medical device Guidance Document a certain group of medical devices were either deemed…
Read MoreElectronic and Radiological Devices Accession Numbers
Electronic and Radiological Devices Accession Numbers Electronic and radiological device accession numbers are one of several parts of bring a radiation emitting product to market. Accession numbers refer to the unique FDA identifiers for electronic product reports found in FDA’s radiation emitting electronic product database. The accession number is provided in response to mandatory reporting for electronic and radiolgoical…
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