Blog

Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.

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FDA Embargo

FDA Embargo FDA embargos typically refer to state embargos since this is not an enforcement tool used by FDA or allowed under the Food Drug…

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510(k) Process

510(k) Process There are many questions about the 510(k) process, but none is more common than, “how long does it take?” The stock answer of…

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Plasma Microneedling

Plasma microneedling is a new medical device raising a number of questions. The most common question received is, “is it FDA cleared or FDA approved?”…

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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…

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Redacting 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…

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FDA 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…

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FDA Due Dilligenc​e 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…

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FDA 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,…

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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…

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Hemp 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…

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Microneedling 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…

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Microneedling Update

Microneedling 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…

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