WARNING LETTER
Wholesome Wellness
MARCS-CMS 612257 —
February 18, 2021
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Jimmy Nguyen
Recipient Title
Owner
Wholesome Wellness
6804 NE 79th Court
Portland
,
OR
97218
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
RE: [CMS:612257]
Dear Mr. Nguyen,
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.wholesome-wellness.com
in December 2020 and has determined that you take orders there for your Natural Anxiety & Depression Relief product. The claims on your website establish that your
product is drug 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 it is 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 “Natural Anxiety & Depression Relief” is intended for use as a drug include:
On the webpage for Natural Anxiety & Depression Relief:
Product name:
"Natural Anxiety Depression Relief"
Product label image:
"Helps fight against depression"
"[contains] 7 healing herbs … [that] act as a natural antidepressant"
"Fight Off … Depression, and Anxiety the Natural Way!"
"Gotu Kola [an ingredient in Natural Anxiety & Depression Relief] … is used to soothe … wound healing, and disease prevention."
"Rhodiola Root [an ingredient in Natural Anxiety & Depression Relief] ... reducing ... depression, and anxiety ...."
"St. John’s Wort [an ingredient in Natural Anxiety & Depression Relief] ... alleviating (and protecting against) diseases. ... [T]he herb’s efficacy to manage mild-to-moderate depression was recognized, presenting fewer side effects than other prescription antidepressants."
"Ashwagandha Root [an ingredient in Natural Anxiety & Depression Relief] ... to reduce the symptoms of ... anxiety disorders. ... effective herbal ... anxiety, and depression remedy ...."
"Lemon Balm Leaf [an ingredient in Natural Anxiety & Depression Relief]:  . . . [T]he herb has been used in various ways, such as treatment for a range of medical disorders . . ..  [T]he herb contains compounds . . . that are responsible for its . . .  anti-inflammatory, and antithrombotic properties."
"Ginkgo Leaf [an ingredient in Natural Anxiety & Depression Relief]: ... Chinese herbalists prepare the herb in formulas ... and mixed in different decoctions to cure diseases. . . . [T]he Ginkgo Leaf extract protects . . . against neuronal damage."
"Eleuthero Root [an ingredient in Natural Anxiety & Depression Relief] . . . treats various conditions such as diabetes, cognitive disorders, and frequent colds."
"If stress stays within your system for weeks or months, it could weaken your immune system and develop physical and psychological problems such as high blood pressure, heart disease, fatigue, depression, anxiety, and so on."
Your Natural Anxiety & Depression Relief product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” 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 Natural Anxiety & Depression Relief product is 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 its intended purposes. Accordingly, your Natural Anxiety & Depression Relief product fails to bear adequate directions for its intended use and, therefore, the product is 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 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