Skull Smash LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your “SKULL SMASH® AMMONIA INHALANTS,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Passage 2

these products are intended for use as stimulant drug products.

Passage 3

“SKULL SMASH® AMMONIA INHALANTS . . . SNIFF-LIFT-DOMINATE” [from your product label]

Passage 4

“This potent, mint scented edition is sure to get your attention, amp up your alertness and aggression, and deliver a punch, like an ice cycle straight to your brain.” [from Facebook website at https://www.facebook.com/skullsmash.ammoniainhalants/]

Passage 5

“BADASS BITCH . . . SKULL SMASH AMMONIA INHALANTS . . . DON’T BE A BASIC BITCH…BE A BADASS BITCH . . . SNIFF – LIFT – DOMINATE” [from your product label]

Passage 6

“DOUBLE BARREL™ . . . By: Skull Smash® Ammonia Inhalants . . . SNIFF – LIFT – DOMINATE [from your product label]

Passage 7

“SKULL SMASH® SILVER BULLET AMMONIA INHALANTS . . . SNIFF-LIFT-DOMINATE” [from your product label]

Passage 8

“Smelling salts are common in strength sports to help mentally stimulate and ‘psych up’ the lifter on competition day or in training to give them a boost on their competitive lifts. They are also popular in combat contact and team sports to increase alertness and focus.” [from your website at https://skull-smash.com/about]

Passage 9

“**Benefits** . . . ● Increased levels of alertness . . . ● Elevated levels of focus . . .● Instantaneous boost of power and energy in competitive strength sports” [from your website at https://skull-smash.com/about]

Passage 10

No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for the products identified above.

Passage 11

these reflex stimulant drug products are deemed to be new drugs under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), because they are subject to a determination to be not GRASE in a proposed rule that is the most recently applicable proposal issued under 21 CFR part 330.

Passage 12

the FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “SKULL SMASH® Ammonia Inhalant,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.

Passage 13

“SKULL SMASH® Ammonia Inhalant,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subjects of applications approved under section 505 of the FD&C Act, 21 U.S.C. 355.