WARNING LETTER
Native Salts LLC
MARCS-CMS 674277 —
February 28, 2024
Product:
Drugs
Recipient:
Recipient Name
Andrew J. Pickens
Native Salts LLC
515 N. Noble St.
Chicago
,
IL
60642
United States
wakeup@nativesalts.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
WARNING LETTER
February 28, 2024
Dear Mr. Pickens:
This letter concerns your firm’s distribution of an over-the-counter (OTC) stimulant drug product. The U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.nativesalts.com on November 15, 2023. We also reviewed your social media websites at https://www.facebook.com/nativesalts1, where you direct consumers to your website, https://www.nativesalts.com to purchase your product.
“
N
, Native Salts” drug product is an unapproved new drug 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 is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such a product 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
“
N
, Native Salts” is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is 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 it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as a stimulant drug product.
Examples of the claims observed on the “
N
, Native Salts” labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:
“Instant Alertness[:] Native Salts provide a quick and easy way to regain focus, improve energy, and get back to things that matter most to you.” [from your product’s website at https://www.nativesalts.com/]
“Native Salts is an all-natural, handmade smelling salts that you can actually use everyday and does not only produce an energizing and alert sensation but also smells pleasant and aromatic.” [from your product’s website at https://www.nativesalts.com/]
“Is Native Salts healthy? Native Salts are composed of simple organic ingredients to provide a natural, refreshing, & alert sensation. They are an invigorating way to stay alert without caffeine. …. We take pride that our smelling salts are all-natural, aromatic, while keeping you alert!” [from your product’s website at https://www.nativesalts.com/faq]
“Is Ammonia in Native Salts dangerous? …Smelling salts, like Native Salts, contain a heavily diluted form of ammonium, which gives off ammonia gas. Think of it like this, inhaling pure ammonia is like doing a belly flop off of an Olympic high dive. It's going to hurt a lot. Inhaling Native Salts is like doing a cannonball off the side of the pool. It's going to wake you up and give you a tiny boost of adrenaline.” [from your product’s website at https://www.nativesalts.com/faq]
“When Should I Use Native Salts? They are most commonly used during sports games or at the gym for strenuous exercise and to aid in getting that last rep up. The great part about Native Salts is that it can be used in a variety of settings outside of lifting and intense workouts. In most scenarios, it can give you a quick jolt of energy when you're tired while avoiding caffeine. Its other usages can vary from waking up in the morning, before a yoga class, a work meeting, a big exam, or even while out at a bar with friends.” [from your product’s website at https://www.nativesalts.com/faq]
“When you want a pick-me-up, but don’t want a caffeine crash.” [from a post on your Facebook webpage, dated 8/21/2023, at https://www.facebook.com/nativesalts1]
Based on the above labeling claims, your “
N
, Native Salts” drug product, containing the ingredients ammonium, eucalyptus oil, peppermint oil, polymer crystals, glycerin, and water, is intended for use as a stimulant drug product. Specifically, this product is intended for use as both a reflex stimulant (i.e., smelling salt, ammonia inhalant) and, more generally, as a stimulant to help restore mental alertness or wakefulness. As described below, this stimulant drug product is an unapproved new drug 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 the FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your firm’s “
N
, Native Salts” drug product.
“
N
, Native Salts” is a reflex stimulant drug product subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Specifically, this reflex stimulant drug product falls under section 505G(a)(4) of the FD&C Act, 21 U.S.C. 355h(a)(4), because it is 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, “
N
, Native Salts” is deemed to be a new drug 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 “
N
, Native Salts” was not marketed as a reflex stimulant drug product and was only marketed as a more general stimulant drug product, your product would still not meet the requirements under section 505G, under which it 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 GRASE and not a “new drug” if, among other things, they conform to the conditions of use set forth in the Over-the-Counter Monograph, M011: Stimulant Drug Products for Over-the-Counter Human Use (hereinafter M011).
4
However, your “
N
, Native Salts” stimulant drug product does not conform to the conditions of use specified in Monograph M011 because your nonprescription product is formulated with the active ingredient ammonium
5
and labeled with directions for intranasal administration, neither of which comply with the applicable conditions of use specified in M011, as set forth in the final administrative order OTC000025. Therefore, even if “
N
, Native Salts” was marketed as only a general stimulant drug product, it would not meet the requirements under section 505G, under which it would 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 “
N
, Native Salts” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Further, as noted above, there are no approved applications in effect for this product. Accordingly, this product is an unapproved new drug marketed in violation of sections 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, “
N
, Native Salts” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject 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 may exist in connection with your product. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov and include your firm name in the subject line of your email.
Sincerely,
/S/
CAPT Tina Smith
Office Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
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) and 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
OTC stimulant drug products are subject to Over-the-Counter Monograph M011: Stimulant Drug Products for Over-the-Counter Human Use, as set forth in a final administrative order established under section 505G of the FD&C Act. (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:
03/05/2024
Regulated Product(s)
Drugs