On Nov. 5, 1982, the U.S. Food and Drug Administration (FDA) published requirements of the tamper-resistant packaging (TRP) regulations covering most OTC products. Tamper-resistant Packing Regulations were issued by FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules.

The packaging must use an indicator or barrier to entry that is distinctive by design (such as an aerosol container), or must employ an identifying characteristic (a pattern, name, registered trademark, logo, or picture). Further, the regulations require a labeling statement on the container (except ammonia inhalant in crushable glass ampules, aerosol products, or containers of compressed medical oxygen) to alert the consumer to the specific tamper-resistant feature(s) used. The labeling statement is also required to be placed so that it will be unaffected if a TRP feature is breached or missing.

The Federal Anti-Tampering Act passed the U.S. Congress in 1983 made it a crime to tamper with packaged consumer products.