Posts by Marc Sanchez
CBD
Cannabidiol or CBD, is a common ingredient seen in a lot of products, especially dietary supplements. But what is the regulatory status of CBD? This is a question that our office routinely receives but is heard more frequently following the passage of the Agriculture Improvement Act of 2018. Many wondered if CBD was a legal…
Read MoreHEMP GRAS
The FDA recognized Hemp as GRAS today. The FDA Atty law firm worked with Fresh Hemp Foods Ltd. (Manitoba Harvest) to file GRN 000765, GRN 000771, and GRN 000778 on ingredients derived from hemp seeds. Today is the first time hemp has ever been recognized as GRAS. A link to the announcement is here. “GRAS”…
Read MoreMicroneedling 510(k)
The first microneedling 510(k) has been filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The FDA Atty firm worked with Esthetic Education LLC to file a microneedling 510(k) for its SkinStylus SteriLock MicroSystem. The SkinStylus is now under a 90-day review. The SkinStylus Sterilock system is unique as it’s…
Read MoreThe Microneedling Classification Update
The FDA formally issued a Microneedling Classification Order on Friday (link here). Unlike before, the Final Order is now codified in the Code of Federal Regulations (CFR). The effective date was Friday and will be codified as 21 CFR 878.4430, which marks the typical 90-days for the FDA to publish a classification order. If you thought the…
Read MoreFDA FSVP
FDA FSVP and FSMA Enforcement Update Marc recently attended the Food and Drug Law Annual conference as a speaker alongside FDA’s interim director of FSMA Operations, Jennifer Thomas. Marc and Jennifer were also joined by Steve Armstrong of EAS consulting. Together they present on key updates from the FDA’s enforcement of FSMA. The FDA’s FSVP…
Read MoreMicroneedling Classification Order
The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was issued in response to a De Novo application submitted by Bellus Medical. The Microneedling Classification Order follows a microneedling guidance issued on Sept. 14, 2018. The Draft Guidance document is available here. (Previous posts on…
Read MoreGovernment Shutdown
A government shutdown now seems increasingly likely (see, Reuters latest headline). This blog wrote extensively on the 2013 Government shutdown (here, here, and here). Although unpredictable and difficult to plan around on short-notice it is important to be aware of the impact this could have. One that affects both industry and consumers. In the event the…
Read MoreFDA Warning Letters 2017
FDA Warning Letters 2017 is a post summarizing last year’s Warning Letters. Each year the FDA releases an enforcement report along with a summary of Inspectional Observations from the previous fiscal year. As an FDA attorney, it is important for my firm to understand enforcement trends to help clients respond to a range of FDA…
Read MoreFDA Bitcoin
FDA Bitcoin related questions are cropping up as the cryptocurrency continues to gain steam. This post discusses whether the FDA accepts Bitcoin or whether Bitcoin or blockchain technologies are FDA approved. The first question bound to bubble-up at some point – does the FDA accept Bitcoin? The short answer is, no. The FDA does not accept…
Read MoreCDER Direct
CDER Direct is one of two tools commonly used for drug establishment registration, National Drug Code (NDC) relabeler code request, and drug listings. It is intended as an improvement on the Electronic Submissions Gateway (ESG) portal that relies on a SPL X-form editor. The integration of the SPL-X editor into the system is one of its…
Read MoreFDARA Marketing Status Report
FDARA Marketing Status Report deadline about 4-weeks away. In August 2017, the FDA Reauthorization Act of 2017 (FDARA), was passed and signed into law. FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA)…
Read MoreFDA Homeopathic Drugs
FDA Homeopathic Drugs are subject to a new enforcement policy that could lead to big changes. Current homeopathic drugs are the subject of a Compliance Policy Guide (CPG), which is an explanatoryatory note for FDA staff and industry. As CPG Sec. 400.400 explains, the FDA recognizes and permits homeopathic drugs recognized by a Homeopathic Pharmacopeia.…
Read More