Posts by Marc Sanchez
HPHC
HPHC or Harmful and Potentially Harmful Constituents is a submission required under the 2016 Deeming Regulation. By November 8, 2019, vape (e-liquids and hardware), hookah and cigar companies (manufacturers, importers or agents) will need to file an HPHC. There’s been confusion about what an HPHC submission involves. In particular, since the last FDA Guidance was…
Read MoreRedacting a FOIA Request
Redacting a FOIA Request – Tips & Insights The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request copies of records not normally prepared for public distribution. This includes regulatory submissions (e.g., NDAs, 510(k)s, PMTA, etc.) and enforcement materials and correspondence (e.g., Warning Letter responses, Form 483s, It…
Read MoreFDA Approved Meaning
FDA Approved Meaning One of the most frequently asked questions by clients and the public alike is what FDA approved means. The difficulty is there is no single answer. Typically, what someone is trying to say or imply is that their individual product or formula was subject to some type of review where the FDA…
Read MoreFDA Due Dilligence Review
FDA Due Diligence Review Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic company, you need to prepare for an FDA due diligence review. An FDA due diligence review is an opportunity for the buyer to review your company’s regulatory compliance, compliance history,…
Read MoreFDA Shutdown
FDA Shutdown The partial government shutdown, now in its 24th day with impacts at the FDA felt across all its Centers. Currently, with the FDA shutdown, most if not all functions are limited to safety inspections. In a series of tweets on Sunday, FDA Commissioner Scott Gottlieb, M.D. stated the shutdown, “represents one of the most significant operational…
Read MoreCBD
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)
Microneedling 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…
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 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…
Read MoreMicroneedling Classification Order
Microneedling 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.…
Read MoreGovernment Shutdown
Government 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…
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