Regulation

Skin boosters in Panama: what Law 491 says and doesn't

Hyaluronic acid and polynucleotides for skin quality in Panama: Law 491 regulates "modeling and filler substances," but it is unclear whether skin boosters fall under it, and we could not find the Ministry of Health's list.

Published November 14, 2026 · 6 min read · 17 sources

Skin boosters in Panama: the question the law leaves open

A "skin booster" is not a volumizing filler: it is a shallow intradermal injection of non-cross-linked hyaluronic acid or polynucleotides aimed at improving skin quality (hydration, texture, elasticity) rather than restoring volume. That difference matters in Panama since President José Raúl Mulino sanctioned Law 491 on October 17, 2025, which regulates "modeling and filler substances"13. The practical question for dermatologists and plastic surgeons is whether a biostimulation product falls into that category. With the sources we could verify, the answer is not written down.

This piece builds on who may inject fillers and toxins in Panama and Law 491 and its background. For the science of polynucleotides, see Polynucleotides and PDRN: efficacy and safety.

What Law 491 establishes in Panama

  • Purpose: according to Panamá América, the law "establishes the regulatory framework for the use, application and marketing of modeling and filler substances"3.
  • Who applies them: TVN and Telemetro report that only "suitable physicians" who are specialists in Dermatology or Plastic Surgery, accredited by the Consejo Técnico de Salud, may apply them12. Panamá América quotes the same phrase but adds general physicians with certified aesthetic competencies3.
  • Minsa list: Minsa issues and updates the official list "every 90 days or when necessary"2. Panamá América adds that it must be issued no later than 30 days after the law takes effect and published on Minsa's website3.
  • Fines: B/.10,000 to B/.50,000 for promoting, producing, importing or applying non-permitted products, per Telemetro2; TVN breaks them down under article 13: B/.10,000 for producing, advertising or donating; B/.15,000 for importing, exporting or selling; B/.50,000 for applying without Minsa authorization1.
  • Informed consent: must detail components, possible complications, adverse effects and risks2.

A note on method: we could not read the official text. The Gaceta Oficial link cited by TVN points to issue 30391 of October 21, 2025, and when we opened it on November 14, 2026 its three pages held a Ministry of Culture resolution about a children's story contest, not the law4. So we do not give the Gaceta number for Law 491, and article numbers come from TVN1.

Do hyaluronic acid and polynucleotides fall under it?

According to TVN, the scope centers on injectables such as biopolymers, polymers and other non-biodegradable or permanent substances, and the report does not mention hyaluronic acid1. Panamá América describes the prohibition as "non-reabsorbable, non-biodegradable biopolymers, polymers and derivatives" and does not mention it either3. None of the open sources mentions polynucleotides.

But the definition of "non-permitted" is wider than "permanent." According to TVN, article 3 treats as non-permitted any substance Minsa has not authorized or that endangers life or physical integrity1. And article 4 requires permitted substances to appear on the official list1. Read that way, a skin product Minsa has not listed could be left uncovered even if it is reabsorbable. That is our reading of what was reported, not an authority's position.

The legislative record shows Minsa never liked the list. Bill 18 had passed third debate by October 25, 2024, when Panamá América reported it, with fines of 3, 5 and 10 base salaries5. When the Executive partially vetoed it on December 13, 2024, it objected to article 4 (the list) because, according to Minsa, publishing lists of permitted and non-permitted substances was inconsistent: "the only substances that should be used are those with a sanitary registration"6. That rule already exists in Law 419, whose article 25 says covered products "require obtaining a sanitary registration for their general handling"8. For a skin booster the underlying question is therefore twofold: does it hold a sanitary registration in Panama, and is it on the article 4 list?

The debate over who should apply: specialists versus general physicians

When the veto was discussed, the Panamanian Association of Plastic, Aesthetic and Reconstructive Surgery (APCPER) asked that only dermatologists and plastic surgeons be the qualified practitioners and that "medical suitability not be given to a technical career"; its spokesman, Dr. Luis Carlos Moreno, said the association "was never consulted"7. That tension returns today: Panamá América's version about general physicians with certified competencies is the one that would most change practice for anyone applying skin boosters in general consultation3.

What the clinical evidence says about skin boosters

For physicians, regulation meets a modest evidence base.

  • Hyaluronic acid: a systematic review of 13 studies, out of 2,996 screened, found improvement in hydration, firmness, brightness, texture and elasticity with a good safety profile, and called for large randomized trials9.
  • Polynucleotides: a systematic review of nine studies, of low and moderate quality, covering 219 patients, reported improvements in wrinkles, texture and elasticity with mild, transient side effects, and concluded there is limited consensus on optimal use10. Another, of seven randomized trials with 183 participants, reported no serious adverse events but flagged small samples and heterogeneous protocols13.
  • Head-to-head: a 2026 review of the periorbital region concluded hyaluronic acid remains superior for structural correction while polynucleotides improve dermal quality parameters; heterogeneity prevents definitive conclusions12.
  • Nomenclature: PN and PDRN differ in polymer length and mechanism, according to a 2025 review, which complicates speaking of "one" product11.
13studies in the systematic review of hyaluronic acid for facial skin quality9
219patients treated with polynucleotides across nine reviewed studies10
2randomized polynucleotide trials flagged as retracted in PubMed1416
B/.50,000Law 491's maximum fine, for applying without Minsa authorization1

One detail a purchasing committee should know: the 2014 trial comparing a polynucleotide filler with hyaluronic acid for crow's feet is flagged as retracted in PubMed16, and the 2025 trial comparing polycaprolactone with polynucleotides was also retracted in 20261415. Part of the most-cited comparative literature no longer stands.

Risks: why regulators look at superficial injections

A product being reabsorbable does not make it harmless. A review of the world literature identified 48 new published cases of vision loss after filler injection between 2015 and 2018; hyaluronic acid caused 81.3% of them, and only 10 patients recovered vision completely17. Those cases involve volumizing fillers, not intradermal skin boosters, but they illustrate why a health authority prefers a list of authorized products.

What to do while it gets clarified

  • Ask Minsa for the current list and the date of its last update; the law provides for reviews every 90 days2.
  • Check the sanitary registration of any injectable skin product you use or order; Law 419 requires it8.
  • Confirm whether your Consejo Técnico de Salud accreditation covers your specialty, since sources differ on the scope13.
  • Document components and risks in the informed consent, which the law requires to be detailed2.

This article is regulatory and evidence journalism, not legal advice. Alphagenics products are for research use only and are not intended for human or veterinary use.

Sources

  1. TVN. Sancionan ley que regula tratamientos estéticos con biopolímeros y polímeros. 21 de octubre de 2025. tvn-2.com ↗
  2. Telemetro. Presidente Mulino sanciona ley que regula el uso y aplicación de relleno en tratamientos estéticos. 21 de octubre de 2025. telemetro.com ↗
  3. Panamá América. Mulino sanciona ley que regula el uso de sustancias en tratamientos estéticos. 21 de octubre de 2025. panamaamerica.com.pa ↗
  4. Gaceta Oficial Digital No. 30391, 21 de octubre de 2025, archivo 115389.pdf (enlace citado por TVN; abierto el 14 de noviembre de 2026: Resolución MC-OAL-R-No. 289-25 del Ministerio de Cultura). gacetaoficial.gob.pa ↗
  5. Panamá América. Aprueban proyecto de ley que regula uso de biopolímeros. 25 de octubre de 2024. panamaamerica.com.pa ↗
  6. Panamá América. Presidente objeta proyecto de ley sobre regulación de sustancias y rellenos modelantes. 13 de diciembre de 2024. panamaamerica.com.pa ↗
  7. Panamá América. Como prudente califican objeción presidencial sobre sustancias modelantes. 17 de diciembre de 2024. panamaamerica.com.pa ↗
  8. República de Panamá. Ley 419 de 2024, que regula los medicamentos y otros productos para la salud humana (art. 25; texto vía vLex). vlex.com.pa ↗
  9. Ghatge AS, Ghatge SB. The Effectiveness of Injectable Hyaluronic Acid in the Improvement of the Facial Skin Quality: A Systematic Review. Clin Cosmet Investig Dermatol. 2023. PubMed 37038447 ↗
  10. Lampridou S, et al. The Effectiveness of Polynucleotides in Esthetic Medicine: A Systematic Review. J Cosmet Dermatol. 2025 Feb. PubMed 39645667 ↗
  11. Kim ST, et al. Comparison of Polynucleotide and Polydeoxyribonucleotide in Dermatology: Molecular Mechanisms and Clinical Perspectives. Pharmaceutics. 2025 Aug 7. PubMed 40871045 ↗
  12. Khan RS, et al. Hyaluronic Acid Fillers Versus Polynucleotides for Under-Eye Rejuvenation. J Clin Med. 2026 Jun 26. PubMed 42452433 ↗
  13. Alhussain AM, et al. Polynucleotides and Polydeoxyribonucleotides for Skin Rejuvenation, Postoperative Scar Prevention, and Wound Healing: A Systematic Review of Randomized Clinical Trials. Cureus. 2026 Jul. PubMed 42572627 ↗
  14. Choi SY, et al. A Randomized, Participant- and Evaluator-Blinded, Matched-Pair, Prospective Study Comparing the Safety and Efficacy Between Polycaprolactone and Polynucleotide Fillers in the Correction of Crow's Feet. J Cosmet Dermatol. 2025 Jan. [RETRACTED / RETRACTADO] PubMed 39313949 ↗
  15. Retraction: A Randomized, Participant- and Evaluator-Blinded, Matched-Pair, Prospective Study Comparing the Safety and Efficacy Between Polycaprolactone and Polynucleotide Fillers in the Correction of Crow's Feet. J Cosmet Dermatol. 2026 Mar. PubMed 41834780 ↗
  16. Pak CS, et al. A phase III, randomized, double-blind, matched-pairs, active-controlled clinical trial and preclinical animal study to compare the durability, efficacy and safety between polynucleotide filler and hyaluronic acid filler in the correction of crow's feet. J Korean Med Sci. 2014 Nov. [RETRACTED / RETRACTADO] PubMed 25473210 ↗
  17. Beleznay K, et al. Update on Avoiding and Treating Blindness From Fillers: A Recent Review of the World Literature. Aesthet Surg J. 2019 May 16. PubMed 30805636 ↗

Informational article. It summarizes news, official statements and published studies; it is not medical or legal advice. Sources were checked on the publication date.

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