WARNING LETTER
Native Remedies dba Silver Star Brands
MARCS-CMS 612268 —
February 18, 2021
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Bruce Valk
Native Remedies dba Silver Star Brands
250 City Center
Oshkosh
,
WI
54906
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
RE: [CMS:612268]
Dear
Mr. Valk
,
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.nativeremedies.com
in
December 2020 and has determined that you take orders there for your
MindSoothe
Drops and
MindSoothe
Capsules
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 these products 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 products are intended for use as drugs include:
MindSoothe Drops
"Relieves feelings of depression"
"Regulates disturbed sleep patterns (insomnia or hypersomnia)"
"Improves disturbed appetite (loss of appetite or binge eating)"
"
MindSoothe
™ should be taken when there is a noticeable loss of interest in activities that are normally enjoyable, a change in eating habits (such as overeating or appetite loss), or difficulty concentrating, remembering details, and making decisions."
MindSoothe Capsules
"Relieves feelings of depression"
"Regulates disturbed sleep patterns (insomnia or hypersomnia)"
"Improves disturbed appetite (loss of appetite or binge eating)"
"MindSoothe is ...formulated to relieve the symptoms of depression. ...without any of the harmful side effects possible with prescription medicine."
"Supporting emotional health... depression-free." [ellipsis in original]
Your
website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
"Your
MindSoothe
remedy helped my depression so much!"
Your
MindSoothe
Drops and
MindSoothe
Capsules
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
MindSoothe
Drops and
MindSoothe
Capsules
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 products safely for their intended purposes. Accordingly, your
MindSoothe
Drops and
MindSoothe
Capsules
products fail to bear adequate directions for their inte
nded use and, therefore, these 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 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 violations cited in this letter.  Failure to promptly address 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)
Drugs
Food & Beverages