Has the FDA issued any approvals, clearances, or warnings about gelatide since 2020?

1. What the record shows about “gelatin,” not “gelatide”

The FDA maintains public pages and regulatory listings for gelatin and collagen — for example an FDA export list for collagen and gelatin and GRAS-related rules — which document that gelatin is regulated for food and manufacturing uses and eligible for export lists under established definitions ^{[1] [4]}. Those pages and related FDA materials describe how gelatin is treated in food law but do not identify a product or substance named “gelatide” ^{[1] [4]}.

2. FDA safety and policy actions that touch gelatin since before and after 2020

FDA materials record substantive policy moves relevant to gelatin: a rule clarifying that gelatin manufactured by customary industry processes is not a prohibited cattle material under BSE-related rules, and ongoing GRAS/food-additive listings that set permitted uses and levels for gelatin in foods ^{[3] [4]}. These are regulatory frameworks and lists rather than product-by-product approvals or single-product clearances ^{[3] [4]}.

3. Approvals, clearances, and withdrawals cited in available sources

Some non‑FDA sources referenced in the result set assert historical agency actions — such as statements that gelatin is GRAS or that FDA “withdrew approval for the use of all intravenous drug products containing gelatin” — but those claims are in third‑party summaries (DrugBank, ScienceDirect) rather than primary FDA press releases in the provided set; the FDA primary pages in this collection do not show a specific post‑2020 approval, clearance, or warning that mentions a product named “gelatide” ^{[2] [5] [6]}. Where DrugBank or academic papers assert FDA positions, confirmatory FDA citations are not present in the supplied results ^{[5] [6]}.

4. Warning letters and label enforcement involving gelatin

Warning letters and enforcement actions sometimes reference capsule ingredients such as gelatin (for example past FDA letters discussing undeclared capsule materials), and industry commentaries summarize such letters — but the assembled sources include a commercial summary of warning‑letter themes rather than an FDA warning letter that names “gelatide” or a specific gelatin product since 2020 ^{[7] [8]}. The FDA’s main warning‑letter index exists ^[8], but no supplied item from that index names gelatide.

5. Gaps, competing claims, and what’s not in the reporting

The supplied material contains numerous documents about gelatin’s regulatory status, market use, and technical applications ^{[2] [1] [9]}, but none of the items provided mention a product, active ingredient, or company brand called “gelatide.” Therefore any claim that the FDA approved, cleared, or warned about “gelatide” since 2020 is unsupported by the available sources — not contradicted explicitly, but simply not found in current reporting (available sources do not mention gelatide) ^{[1] [2]}.

6. How to verify further (practical next steps)

To settle the question definitively: search FDA primary databases by the exact term “gelatide” in Drugs@FDA, Devices@FDA, FDA warning letters, and the Food Additive/GRAS databases; inspect FDA press releases and the Federal Register for the years 2020–2025; and check company filings or 510(k)/PMA records if “gelatide” is a device or drug candidate. The materials provided here include the FDA export/collagen pages and the CFR/GRAS listings that you would cross‑check, but they do not supply a match for “gelatide” ^{[1] [4] [3]}.

Limitations and note on sources: my analysis relies solely on the set of documents you provided. Those items comprehensively cover gelatin policy but do not include an FDA document, warning letter, approval notice, or clearance record that mentions “gelatide” by name; therefore definitive proof either way is outside the scope of the current file set (available sources do not mention gelatide) ^{[1] [8]}.