WARNING LETTER
Skull Smash LLC
MARCS-CMS 672714 —
March 13, 2024
Product:
Drugs
Recipient:
Recipient Name
Steve Welch
Recipient Title
Owner
Skull Smash LLC
3101 Bartold Avenue
Maplewood
,
MO
63143-3600
United States
steve@liftersbag.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
WARNING LETTER
March 13, 2024
RE: 3029879389
Dear Mr. Welch:
This letter concerns your firm’s distribution of over-the-counter (OTC) stimulant drug products. On November 16, 2023 the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address (https://www.skull-smash.com) and on November 20, 2023, your social media account on Facebook, where your “SKULL SMASH® AMMONIA INHALANTS,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” drug products are available for purchase in the United States. Based on our review, FDA has concluded that 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). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.
Unapproved New Drug and Misbranded Drug Violations
“SKULL SMASH® AMMONIA INHALANTS,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as stimulant drug products.
Examples of the claims from the products’ labeling, including your product labels, website, and social media account on Facebook, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:
“
SKULL SMASH® AMMONIA INHALANTS
”
“SKULL SMASH® AMMONIA INHALANTS . . . SNIFF-LIFT-DOMINATE” [from your product label]
“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/]
“
BADASS Bitch
”
“BADASS BITCH . . . SKULL SMASH AMMONIA INHALANTS . . . DON’T BE A BASIC BITCH…BE A BADASS BITCH . . . SNIFF – LIFT – DOMINATE” [from your product label]
“
DOUBLE BARREL™ Ammonia Inhalant
”
“DOUBLE BARREL™ . . . By: Skull Smash® Ammonia Inhalants . . . SNIFF – LIFT – DOMINATE [from your product label]
“
SILVER BULLET Ammonia Inhalants
”
“SKULL SMASH® SILVER BULLET AMMONIA INHALANTS . . . SNIFF-LIFT-DOMINATE” [from your product label]
Website Claims for Ammonia Inhalants
:
“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]
“
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]
Based on the above labeling claims, “SKULL SMASH® Ammonia Inhalant,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” drug products containing the ingredient ammonium carbonate are intended for use as stimulant drug products. Specifically, these products are intended for use as both reflex stimulants (i.e., smelling salts, ammonia inhalants) and, more generally, as stimulants to help restore mental alertness or wakefulness. As described below, these stimulant drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
In general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). 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.
“SKULL SMASH® Ammonia Inhalant,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” are reflex stimulant drug products subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, 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. The term “smelling salt” typically is used to refer to an ammonia aromatic preparation used as a reflex stimulant.
1
On June 19, 2008, FDA issued a proposed rule (73 FR 34895)
2
setting forth a determination that ammonia and any other ammonia ingredient in a drug product that is labeled with claims or directions for use as a reflex stimulant are not GRASE or are misbranded. This June 19, 2008 proposed rule is the most recent applicable FDA proposal issued under 21 CFR part 330 with respect to ammonia as a reflex stimulant in OTC drug products. Thus, these reflex stimulant drug products are deemed to be new drugs under section 201(p)(1) of the FD&C Act and subject to the requirement to have an approved new drug application under section 505 of the FD&C Act, 21 U.S.C. 355, beginning on September 23, 2020.
3
Even if “SKULL SMASH® Ammonia Inhalant,” “BADASS Bitch,” “DOUBLE BARREL™ Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” were not marketed as reflex stimulant drug products and were only marketed as more general stimulant drug products, your products would still not meet the requirements under section 505G, under which they would be deemed to be GRASE and not a new drug.
Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. In particular, nonprescription stimulant drug products are deemed to be GRASE and not a new drug if, among other things, they conform to the conditions of use in the Over-the-Counter Monograph, M011: Stimulant Drug Products for Over-the-Counter Human Use (hereinafter M011), as set forth in the applicable final administrative order.
4
However, your “SKULL SMASH® Ammonia Inhalant,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” stimulant drug products do not conform to the conditions of use specified in Monograph M011 because your products are formulated with the active ingredient ammonium carbonate
5
and are labeled with directions for intranasal administration, neither of which are permitted conditions of use under the final administrative order. Therefore, even if “SKULL SMASH® Ammonia Inhalant,” “BADASS Bitch,” “DOUBLE BARREL Ammonia Inhalant,” and “SILVER BULLET Ammonia Inhalants” were marketed only as general stimulant drug products, they would not meet requirements under section 505G, under which they would be deemed to be GRASE and not a new drug.
In addition, 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. Moreover, there is no evident basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).
Lastly, “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. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. Please be aware that you are responsible for investigating and determining the causes of any violations and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to adequately address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot completely address the violations within 15 working days, state your reasons for delay and schedule for completion.
If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please direct your email response to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research - Office of Unapproved Drugs and Labeling Compliance at the following email address to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
_____________________
1
Merriam Webster’s dictionary defines “smelling salts” as “a usually scented aromatic preparation of ammonium carbonate and ammonia water used as a stimulant and restorative.”
2
On June 19, 2008, FDA issued a proposed rule (73 FR 34895) setting forth a determination that ammonia and any other ammonia ingredient in a drug product that is labeled with claims or directions for use as a reflex stimulant are not generally recognized as safe and effective (GRASE) or are misbranded.
3
FDA did not determine that it was in the interest of public health to extend the period during which any drug subject to section 505G(a)(4) may be marketed without an approved new drug application.
4
Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 C.F.R. part 330 prior to enactment of the CARES Act. In the case of OTC stimulant drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M011: Stimulant Drug Products for Over-the-Counter Human Use. (Over-the-Counter Monograph M011 Final Administrative Order (OTC000025))
5
M011 specifies that caffeine, in a form suitable for oral administration, is the only acceptable active ingredient for use as a stimulant under the order.
Content current as of:
03/19/2024
Regulated Product(s)
Drugs