Advocacy Group Calls for Stricter Regulations and Labeling for Botox and Rival Injections

14 December 2023

Public Citizen Petitions FDA to Address Safety and Promotional Concerns Surrounding Botox and Similar Neurotoxin Injections

Public Citizen, a U.S. advocacy group, has raised concerns about the safety and promotional practices surrounding AbbVie’s popular medical and cosmetic injection, Botox. In a petition sent to the FDA, the group called for the removal of misleading promotional statements from the labeling of Botox and its rivals, as well as a strengthening of the black box warning for all approved neurotoxin injections. While Botox dominates the market, Public Citizen’s petition also targets other products, including Daxxify, Jeuveau, Myobloc, Dysport, and Xeomin. The group highlights the potential serious safety risks associated with these neurotoxins and urges the FDA to take action.

The Dominance of Botox in the Medical Aesthetics Field

Botox, a medical and cosmetic injection containing a highly potent neurotoxin, has been the market leader in the medical aesthetics field for over three decades. With annual revenue of approximately $5 billion, Botox has been a significant source of profit for AbbVie since its acquisition of Allergan in 2019. The drug is widely used for cosmetic purposes, such as reducing the appearance of wrinkles, as well as for medical conditions like migraines and incontinence.

Public Citizen’s Concerns and Petition to the FDA

Public Citizen has a longstanding history of advocating for stricter regulations surrounding Botox. In its latest petition to the FDA, the group calls for a stronger black box warning on the labeling of all approved neurotoxin injections, including Botox and its competitors. The current warning, implemented by the FDA in 2009, fails to explicitly mention the risk of “systemic iatrogenic botulism,” a potential complication that can cause muscle paralysis or weakness.

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Addressing Safety Risks and Misleading Promotional Statements

Public Citizen also urges the FDA to remove misleading promotional statements from the labeling of Botox and Botox Cosmetic. The group specifically challenges the claim that there have been no definitive serious adverse events associated with the use of recommended doses of these drugs for certain therapeutic indications and approved cosmetic uses. Regulators in other countries, such as Canada and the U.K., do not endorse this claim. Public Citizen highlights its analysis of the FDA’s safety database, which revealed that Botox was the primary suspect in adverse reactions related to one of the therapeutic indications listed in the misleading claims. Additionally, the group found that 42% of these adverse reactions were suggestive of iatrogenic botulism.

Extending the Concern to Botox Rivals

While Botox holds a dominant position in the market, Public Citizen’s petition also raises concerns about the safety and promotional practices of Botox’s rivals. These include Revance Therapeutics’ Daxxify, Evolus’ Jeuveau, Supernus Pharmaceuticals’ Myobloc, Galderma’s Dysport, and Merz Therapeutics’ Xeomin. Public Citizen emphasizes the need for consistent regulations and labeling standards across all neurotoxin injections to ensure patient safety.

International Regulatory Discrepancies and the Call for Action

Public Citizen’s petition highlights the discrepancies in regulatory approaches to neurotoxin injections. While the FDA’s current labeling and promotional claims have been challenged, other countries’ regulatory bodies have taken a more cautious stance. The group’s analysis of adverse events reported to the FDA suggests that there may be a higher risk of iatrogenic botulism associated with these injections than previously acknowledged. Public Citizen’s call for action aims to protect patients from potential safety risks and ensure accurate and transparent information regarding the use of neurotoxin injections.

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Public Citizen’s petition to the FDA brings attention to the safety and promotional concerns surrounding Botox and its competitors. The advocacy group calls for stricter regulations, including a strengthened black box warning and the removal of misleading promotional statements. By highlighting potential safety risks and international regulatory discrepancies, Public Citizen seeks to ensure patient safety and transparency in the medical aesthetics field. As the FDA reviews the petition, the outcome will have implications for the regulation and labeling of neurotoxin injections, ultimately impacting the millions of individuals who rely on these treatments.

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