WARNING LETTER
Enlifta, LLC
MARCS-CMS 612253 —
February 18, 2021
Delivery Method:
Via Overnight Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Nathan Schumacher
Enlifta, LLC
16372 Page St.
Omaha
,
NE
68118
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
RE: [CMS:612253]
Dear Mr. Schumacher,
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet address, www.enlifta.com
,
in December 2020 and February 2021. FDA observed that your website directs customers to your Amazon pages to purchase your “Enlifta Mood Elevator” and “Enlifta Anxiety” products.
We have also reviewed
product listings on your Amazon page,
https://www.amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/ref=sr_1_2?dchild=1&keywords=Enlifta&qid=1608252523&sr=8-2
and
https://www.amazon.com/Enlifta-Supplement-Ashwagandha-L-Theanine-supplement/dp/B071P2YZNC/ref=sr_1_5?crid=3MDQSIYFRH3C8&dchild=1&keywords=enlifta+anxiety&qid=1608252697&sprefix=Enlifta+an%2Caps%2C169&sr=8-5
.
The claims on your websites and Amazon pages 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 “Enlifta Mood Elevator” and “Enlifta Anxiety” are intended for use as drugs include:
On the webpage for “Enlifta Mood Elevator”:
"The Only Doctor Designed Depression Pill, Enlifta Depression Supplement - Best Natural Antidepressant."
"ENLIFTA: OUR #1 BEST-SELLING DEPRESSION SUPPLEMENT"
“‘Every day a patient was unhappy that their expensive prescription medications for depression weren’t working.  They wanted something more natural & without all the side effects of ‘hard’ prescription drugs.’"
On the webpage for “Enlifta Anxiety”:
“‘A new natural supplement is providing relief to people across America suffering with severe anxiety and stress!’”
The product was created “‘. . . with 7 proven ingredients that remedy severe anxiety.’”
"Chamomile Flower [an ingredient in “Enlifta Anxiety”] . . . can provide treatment as an anti-inflammatory, . . . for insomnia, and for anxiety relief."
"English Lavender Flower Powder [an ingredient in “Enlifta Anxiety”] . . .for the treatment of insomnia and anxiety."
"Passion Flower Herb Powder [an ingredient in “Enlifta Anxiety”] . . . . One study showed it worked as well as a common prescription medication for treating anxiety, but had fewer short-term side effects."
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Enlifta Mood Elevator” and “Enlifta Anxiety” for the cure, mitigation, treatment, or prevention of disease.  Examples of such testimonials include:
"I have tried tons of supplements looking for a depression cure. This is it!!!"
"It is the perfect blend of several natural, non-drug, anti-depressant supplements all in one pill."
"I would recommend enlifta to anyone who needs a [sic] excellent natural remedy for relieving depression and anxiety."
On your linked Amazon page for “Enlifta Mood Elevator”: https://www.amazon.com/Doctor-Designed-Depression-Enlifta-Supplement/dp/B00STR2MLQ/ref=sr_1_2?dchild=1&keywords=Enlifta&qid=1608252523&sr=8-2
:
“NATURAL SAFE & EFFECTIVE ANTIDEPRESSANT FORMULA: More natural alternative to prescription drugs”
“Enlifta is the only natural remedy depression supplement designed & created by a Psychiatrist.”
On your linked Amazon page for “
Enlifta Anxiety”
: https://www.amazon.com/Enlifta-Supplement-Ashwagandha-L-Theanine-Supplement/dp/B071P2YZNC/ref=sr_1_5  crid=3MDQSIYFRH3C8&dchild=1&keywords=enlifta+anxiety&qid=1608252697&sprefix=Enlifta+an%2Caps%2C169&sr=8-5
,
“NATURAL SAFE & EFFECTIVE ANXIOLYTIC FORMULA: More natural alternative to prescription drugs”
“Enlifta is the only natural remedy anxiety supplement designed & created by a Psychiatrist”
“Unlike other supplements and prescription medications, Enlifta Anxiety helps to manage stress and associated anxiety without causing excess fatigue or a ‘medicated’ feeling during the day.”
Your “Enlifta Mood Elevator” and “Enlifta Anxiety” 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 CFR
§
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 “Enlifta Mood Elevator” and “Enlifta Anxiety” 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 “Enlifta Mood Elevator” and “Enlifta Anxiety” 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 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, w
ithin 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 Administratio
n
Content current as of:
02/19/2021
Regulated Product(s)
Food & Beverages