WARNING LETTER
JusByJulie.Com LLC
MARCS-CMS 594139 —
April 13, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Sesar Maleh
Recipient Title
President
JusByJulie.Com LLC
2184 McDonald Ave.
Brooklyn
,
NY
11223-3926
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
WARNING LETTER
CMS# 594139
April 13, 2020
Dear Mr. Maleh:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address, http://www.jusbyjulie.com, in December 2019, and has determined that you take orders there for your products, including Bye Bye Bloat (which includes Citrus Tur-eamsicle Smoothie, Pineapple Bliss Smoothie, Green Fuel Smoothie, Acai Blend Smoothie, Spicy Lemonade, Watermelon Wizard Smoothie, Green Radiance Smoothie, and Assorted Ginger Citrus and Turmeric Shots), 3 Day Cleanse (which includes an assortment of Sweet Spin, Spicy Lemonade / Spicy Pomegranate, Green Radiance, Chia Berry, Choco-nana / Watermelon Wizard / Acai Blend, and X-treme Greens), 5 Day Jus ‘Til Dinner Cleanse (which includes an assortment of Sweet Spin, Spicy Lemonade / Spicy Pomegranate, X-treme Greens, and Chia Berry / Acai Blend), and Ginger Citrus Shot. The claims on your website establish that the 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 for such uses 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:
On your http://www.jusbyjulie.com website:
• Under the web tab “Shop/Meal Replacements”
Bye Bye Bloat:
o “A week’s worth of smoothies and shots to help deal with inflammation and digestive issues. . .*
o
Green Fuel Smoothie
(12oz) – Fruit-forward drink with inflammation-calming celery juice*
o
Watermelon Wizard Smoothie
(12oz) – Hydrating blend of fruits and Maqui Berry powder, a Chilean superfood known for its inflammation fighting properties*”
In addition, your website also includes the following pages:
• “Learn / Which Cleanse? / More questions about cleansing? We've got the answers here / The JUS Journal / How to Kick Start Your Morning Routine Without Coffee /
Read More: Here's Why Blended Juices Are Far Healthier Than Cold Pressed
,” which includes links to pages where you sell the 3 Day Cleanse and the 5 Day Jus ‘Til Dinner Cleanse products:
o “[B]ut that pulp corresponds to higher levels of naringin, a phtyonutrient proven to have cancer-fighting properties. Naringin also regulates inflammation and contains antioxidants that may be able to help treat diabetes and other metabolic disorders. . .”
• “Learn / Which Cleanse? / More questions about cleansing? We've got the answers here / The JUS Journal / 6 Ways To Improve Your Digestion When You Feel Bloated,” which includes a link to a page where you sell the Ginger Citrus Shot product:
o “
Kickstart with Ginger & Lemon
Get the day started off on the right foot by consuming some inflammation fighting ginger and lemon before you eat anything. . .”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. 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 3 Day Cleanse and 5 Day Jus ‘Til Dinner Cleanse 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 3 Day Cleanse and 5 Day Jus ‘Til Dinner Cleanse 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 list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 correct all violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, including your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter, please contact Ms. Aveta at
718-662-5576
or E-mail at lillian.aveta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
Program Division Director
Office of Human and Animal Food Operations East – Division 1
Content current as of:
04/28/2020
Regulated Product(s)
Food & Beverages