Class Action Alleges Performix SST Metabolism Supplement Label Missing Required FDA Disclosure

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A proposed class action claims Performix LLC has unlawfully sold its SST Timed Release Metabolism dietary supplement capsules given the product’s packaging does not include certain required disclosures.

The lawsuit alleges that because the packaging of the supplement includes certain claims regarding its purported ability to affect the human body’s structure or function, including by boosting metabolism, increasing energy and promoting focus, federal regulations mandate that Performix also clarify on the product’s labels that the supplement has not been approved by the FDA and is not “intended to diagnose, treat, cure, or prevent any disease.”

Absent these statements, the Performix SST Time Release Metabolism supplement is considered misbranded and unlawful to sell under federal and California law, the case alleges.

According to the suit, one panel of the SST Time Release Metabolism product states that the dietary supplement is “powered by Caffeine and Capximax to accelerate your body’s metabolism, provide sustained energy, and support fat breakdown.” Other statements on the label claim the product can “increase resting energy expenditure,” “accelerate your own body’s metabolism” and “promote focus, clarity, concentration, and alertness,” the filing adds.

The lawsuit alleges these statements constitute structure/function claims—i.e., claims that the product can affect the body’s structure or function—as defined under the Federal Food, Drug, and Cosmetic Act (FFDCA) and therefore must be accompanied by the following “prominent and bolded” disclaimer:

Without the FDA disclaimer, which the suit notes must be present on each panel of the product’s packaging where a structure/function claim is made, the dietary supplement qualifies as an unapproved “drug” under the FFDCA and is therefore not legal to sell under federal and California law.

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