In response to claims made by some physicians, clinics, and medical companies advertising the unsubstantiated beneficial effects of autologous stem cell therapies, the US Food and Drug Administration (FDA) published 3 draft “guidances” in the Federal Register, between 2007 and 2014, related to the use of aspirated fat and its constituents. The last set of guidances relevant to aspirated fat were the subject of public hearings in September, 2016. These guidances are nonbinding interpretations of federal regulations already on the books. While nonbinding, in their final iteration, they provide insight into how the FDA will interpret existing regulations. Unfortunately, while each guidance has attempted to further clarify the one before, the result has been to make all of them more difficult to assess. The guidances under scrutiny seem to interpret the federal code in a way that would require some clinicians who use human cells, tissues, and cellular-and tissue-based products (HCT/Ps) derived from adipose tissue to register and report as manufacturers. 1 Essentially, the FDA proposes to prohibit the separation and reinjection of the stromal vascular fraction (SVF) of adipose tissue, even in procedures within the same patient. However, upon closer examination, what the guidances really do is to obfuscate the issue and open the door to further misinterpretation, including the possibility of disallowing simple fat injections for a variety of reconstructive and aesthetic procedures for which they have been studied extensively, used for years, and shown to be safe. Board-certified plastic surgeons share the US FDA’s commitment to provide patients with access to safe and effective treatments. In addition, we respect the agency’s tiered, risk-based decision framework, which is intended to balance the need for protecting patient safety with the need for therapeutic alternatives. 2 The FDA is to be commended for undertaking the onerous task of providing regulatory guidelines for the medical use of HCT/Ps. Unfortunately, the recent FDA guidances have the possible unintended consequence of depriving patients in need of certain reconstructive and aesthetic treatments of an inexpensive and useful tool with proven safety and results. In a recent article in Mayo Clinic Proceedings, Dr Turner 3 focuses on several concerns related to the misuse and marketing of adipose-derived autologous stem cell treatments. While plastic surgeons support evidence-based use of stem cell therapies, we agree that the commercial use of these products needs to be further investigated and regulated as necessary to ensure patient safety and efficacy. The FDA’s current regulatory language, however, lacks the required specificity to provide meaningful guidance to healthcare professionals.