WARNING LETTER
Lifted Naturals
MARCS-CMS 612216 —
February 18, 2021
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Sylvia & Tim Hall
Recipient Title
Owner(s)
Lifted Naturals
1101 Mulberry St, A2 Suite 10
Kansas City
,
MO
64101
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
RE: [CMS: 612216]
Dear Sylvia & Tim Hall,
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.liftednaturals.com
in December 2020 and has determined that you take orders there for your Mood Boosting Probiotic product. The claims on your website establish that your
product is a 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 Mood Boosting Probiotic is intended for use as a drug include:
On the Mood Boosting Probiotic product page of your website:
"Our blend is especially potent with our PREBIOTIC, GOS-- the ONLY prebiotic that's been proven to help with anxiety."
On the About Us page of your website:
"After a tough go-around with postpartum depression, Sylvia decided there had to be a better way to feel better. Her research led her down the rabbit-hole of the gut-brain connection. Her idea for a probiotic specifically designed to help with mood and anxiety was the springboard for Lifted and Mood Boosting Probiotic was their first product."
On the Blog page of your website, from a July 20, 2020 post titled, “How do Probiotics Support a Healthy Mood?”:
"Constantly struggling with symptoms of anxiety and depression can have an incredibly detrimental impact on your life. . . . Our vision for the future of mental health is that we reach for probiotics as a first line of defense and even prevention for mental health issues.”
Your Mood Boosting Probiotic 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 Mood Boosting Probiotic 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 Mood Boosting Probiotic product fails to bear adequate directions for their 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 this misbranded drug 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