WARNING LETTER
SANA Group LLC
MARCS-CMS 612256 —
February 18, 2021
Delivery Method:
Via Overnight Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Jason W. Harris
Recipient Title
Owner
SANA Group LLC
1200 E. Woodhurst S-200
Springfield
,
MO
65804
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
RE: [CMS:612256]
Dear Mr. Harris,
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address, www.sleepsana.com
,
in December 2020 and has determined that you take orders there for your Sleep Sana “Sleep Drops” and “Sleep Shots” products. The claims on your website establish that your
products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov
.
Examples of some of the
website claims that provide evidence that your “Sleep Drops” and “Sleep Shots” are intended for use as drugs include:
On the webpage for Sleep Sana “Sleep Drops” and “Sleep Shots” ingredients:
"GABA (an ingredient in your
Sleep Sana “Sleep Drops” and “Sleep Shots” products)
is taken by mouth for relieving anxiety, ... and treating attention deficit hyperactivity disorder (ADHD). It is also used for ... stabilizing blood pressure, and relieving pain."
"L-tryptophan (an ingredient in your
Sleep Sana “Sleep Drops” and “Sleep Shots” products)
is used for insomnia, sleep apnea, depression, anxiety, facial pain, a severe form of premenstrual syndrome called premenstrual dysphoric disorder (PMDD), ... attention deficit-hyperactivity disorder (ADHD), Tourette's syndrome....
"
"Valerian (an ingredient in your
Sleep Sana “Sleep Drops” and “Sleep Shots” products)
is most commonly used for sleep disorders, especially the inability to sleep (insomnia)."
"[Y]our body may produce melatonin (an ingredient in your
Sleep Sana “Sleep Drops” and “Sleep Shots” products)
either earlier or later in the day than usual. This change can lead to symptoms of seasonal affective disorder (SAD), or winter depression."
Your “Sleep Drops” and “Sleep Shots” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C.
§
321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C.
§§
331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C.
§
352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R.
§
201.5).  Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C.
§
353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your “Sleep Drops” and “Sleep Shots” products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for their intended purposes. Accordingly, your “Sleep Drops” and “Sleep Shots” products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C.
§
352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C.
§
331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. 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.
You should take prompt action to address the violates cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these 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 Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so. Your reply should be sent via e-mail to
FDAAdvisory@fda.hhs.gov
.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Content current as of:
02/19/2021
Regulated Product(s)
Food & Beverages