TGA action over alleged unlawful advertising by Booty N Buff Nutrition

The TGA has issued two infringement notices totalling $37,560 to Booty N Buff Nutrition Caringbah Pty Ltd (Booty N Buff Nutrition) in relation to the alleged unlawful advertising of therapeutic goods, contrary to the Therapeutic Goods Act 1989.

The TGA states Booty N Buff Nutrition paid the infringement notices in December 2025.

WHAT THE TGA ALLEGES

The TGA alleges Booty N Buff Nutrition advertised sports supplements that were not included in the Australian Register of Therapeutic Goods (ARTG) and that the products contained Schedule 4 (prescription-only) substances, namely tryptophan and levodopa.

The regulator notes that therapeutic goods not entered on the ARTG have not been assessed by the TGA for quality and safety and may pose a health risk.

WHY SCHEDULE 4 MATTERS

The TGA explains that Schedule 4 substances are prescription-only because of the risks associated with their use and the controls required to protect public health. Decisions to use a prescription-only medicine should be made between a patient and a prescribing practitioner, with informed consent (including discussion of possible side effects).

The TGA reiterates that advertising prescription-only medicines directly to consumers is prohibited under the Act.

WHAT PAYMENT OF AN INFRINGEMENT NOTICE MEANS (AND DOESN’T MEAN)

The TGA’s infringement-notice guidance clarifies that payment discharges the recipient’s liability for the breach specified in the notice and prevents court action in relation to that breach, but payment is not an admission of liability.

Infringement notices are used as one of the TGA’s compliance tools to achieve timely compliance, and that multiple infringement notices can be issued where the regulator believes there have been multiple breaches.

HOW THESE MATTERS COMMONLY ARISE IN THE “SPORTS SUPPLEMENTS” SPACE

The TGA has previously noted that the “sports supplement” category can sit on the food–medicine interface, and classification can be complex. Factors that can shift a product into the therapeutic-goods regime include the dosage form, the presence of a scheduled substance, and the way a product is represented/marketed (including the claims made).

The TGA also advises that products regulated by the TGA generally carry an AUST number on the label and must be included in the ARTG before lawful supply.