Approved vs Cleared vs Authorised
Approved, cleared and authorised are three different FDA outcomes resting on different evidence, and only approval means the agency reviewed data showing the product works for its stated use.
FDA uses distinct verbs for distinct legal acts. A drug is approved through a new drug application or licensed through a biologics license application on evidence of safety and effectiveness. Most moderate-risk devices are cleared through a 510(k), which asks only whether the device is substantially equivalent to a legally marketed predicate, a comparison rather than a demonstration of benefit. High-risk devices go through premarket approval, and novel low-risk ones through De Novo classification.
Authorised is a third thing again. An emergency use authorisation under section 564 permits marketing during a declared emergency on a may-be-effective standard well below approval, and it lapses when the declaration does. Outside the United States the word carries no such implication: the European Commission grants a marketing authorisation on the opinion of the EMA committee, and that is the equivalent of an FDA approval, not of a clearance.
The distinction decides what a claim is worth. Cleared tells you a predicate existed. Authorised tells you an emergency was declared. Approved tells you a review of adequate and well-controlled investigations concluded the product does what its label says. Peptide products sold as research chemicals, as cosmetics or as supplements have been through none of these, which is a different situation from having failed one.
The real abuse is a fourth word, registered. Establishment registration and product listing are administrative filings; FDA registers facilities, it does not approve them, and the agency has repeatedly said that FDA-registered on a label or website is misleading. FDA-approved facility and FDA-approved laboratory are not categories that exist, and neither is FDA-approved ingredient for most of what the phrase is attached to.