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New York District
158-15 Liberty Ave
Jamaica, NY 11433
April 5, 2017
WARNING LETTER NYK-2017-7
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Sesar Melah
Jus Bar LLC
2184 McDonald Avenue
Brooklyn, NY 11223-3926
Dear Mr. Melah:
We inspected your facility located at 2184 McDonald Avenue, Brooklyn, NY 11223-3926, on July 19-21, 2016. In addition, we reviewed your firm’s website at the internet address
http://www.jusbyjulie.com in March 2017
and have determined that you take orders there for your products described below. 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
Further, we reviewed your Sweet Spin, PB& Jus, and Almond Breeze Blended Juices product labels. Based on our review, we have concluded that your products are in violation of section 403 [21 U.S.C. § 343] of the Act, and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
Unapproved New Drugs and Misbranded New Drugs
The following are examples of some of the website claims that provide evidence that your products are intended for use as drugs:
Almond Breeze Blended Juice
- “The addition of heart-healthy cinnamon controls inflammation in the body as well as protects you from cancer, bacterial infections and neurodegenerative diseases.”
Sweet-Spin Blended Juice
- “The bananas and mango also help fight diabetes…”
Cran-Orange Crush Blended Juice
- “We added a bit of creamy cholesterol-lowering avocado…”
Choco Nana Blended Juice
- “Potassium-rich bananas that lower your…blood pressure, disease-fighting pomegranate ...”
All Green Everything Blended Juice
- “[I]t also has the ability to lower bad cholesterol.”
Chia Berry Blended Juice
- “Vitamin C content and anti-bacterial properties. Plus, they can fight cancer-causing agents.”
Spicy Pomegranate Blended Juice
- “[H]elps cure indigestion problems and controls blood pressure.”
Spicy Lemonade Blended Juice
- “[H]elps cure indigestion problems and controls blood pressure.”
Island Coconut Blended Juice
- “[A]n excellent cure for …hangovers.”
Dr. Green Blended Juice
- “Celery and ginger fight inflammation, one of the main causes of several diseases…Vitamin C & A help your body repel viruses and bacteria.”
Citrus Tur-Eamsicle Blended Juice
- “The vibrant turmeric in this juice, a natural anti-inflammatory, keeps the soreness under control…”
Kava Booster Shot
- “Kava is well known for offsetting a number of common life disrupting ailments such as … depression and ADHD”
Turmeric Booster Shot
- “[T]urmeric is a supreme anti-inflammatory …”
Ginger Booster Shot
- “Great for fighting a cold… and clear those stuffy nasal passages.”
Ginger Citrus Booster Shot
- Ginger Citrus… fight off cold & flu symptoms… has major anti-inflammatory properties. It is the perfect sickness fighting combination.”
Hearty Potato Leek Soup
- “[T]he leek is known for reducing your risk for heart disease, high cholesterol and high blood pressure.”
Carrot Turmeric Soup
- “Got a sore throat…pigmented turmeric, which will tame inflammation and burning…”
- “[T]his soup with butternut squash, sweet potatoes and carrots is a triple threat against colds and the flu. All three have the power to increase the number of infection-fighting cells in your body, giving those annoying sniffles a TKO.”
Creamy Carrot Ginger
- “Got a case of the sniffles?”
- “[T]his soup this soup will help you battle even the strongest of colds by preventing bacteria from entering your bloodstream. Plus, the spiciness of the ginger will soothe a sore throat and keep viruses at bay. Goodbye colds…”
- “Plus the mushrooms will fight any inflammation from a cold…”
Your products identified above 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, your Almond Breeze, Sweet-Spin Blended Juice, Chia Berry Blended Juice, and Kava Booster Shotproducts are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use the drugs safely for their intended purposes. Thus, these products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
1. Your Sweet Spin, PB & Jus, and Almond Breeze blended juice products are misbranded within the meaning of section 21 U.S.C. § 343(i)(1) [403(i)(1) of the Act] because the product labels fail to bear an appropriate statement of identity as required by 21 CFR 101.3. All three products appear to bear a fanciful name, but fail to provide an appropriate descriptive term.
Specifically, the fanciful names are all followed by the term “BLENDED JUICES” on the labels in a different type, which is then followed by a list of ingredients that contains fruits/vegetables as well as non-fruit/vegetable ingredients. Since these products are not simply blends of juices, “Blended Juices” is not appropriately descriptive of the products in accordance with the requirements of 403(i)(1) and 21 CFR 101.3.
2. Your Sweet Spin, PB & Jus, and Almond Breeze blended juice products are misbranded within the meaning of section 21 U.S.C. §343(i)(2) [403(i)(2) of the Act] in that they purport to be beverages containing juice; however, they fail to meet the requirements under 21 CFR 101.30. For example,
a. The Sweet Spin and PB & Jus product labels fail to declare an appropriate percent juice statement in accordance with 101.30(b)(1). These products are not 100 percent juice because they also contain a rice beverage ingredient and (for the PB& Jus) peanut butter.
b. The Almond Breeze product does not appear to contain a juice ingredient. Therefore, the product label fails to declare a juice ingredient and a correct percent juice declaration (i.e., something less than 100% juice).
This letter is not meant to be an all-inclusive list of the violations that exist at your firm or that exist in connection with your products. You are responsible for ensuring that your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations in this letter. Failure to promptly correct the violations may result in regulatory action without further notice, such as seizure or injunction.
We offer the following labeling comments:
- For the Almond Breeze product, if the food does not contain any juice ingredient the use of the term “Blended Juice,” would be false and misleading because the product is simply a blend of almonds, cinnamon, and rice beverage.
- If the rice beverage ingredient used in the products is fabricated from more than one ingredient, then the products labels would need to declare all sub-ingredients.
- The allergy statements “contains peanuts,” “contains almonds” should not appear within the nutrition information.
You should respond in writing within fifteen working days from your receipt of this letter outlining the specific steps that you have taken to correct these violations. You should include in your response documentation such as revised product labels and website information, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your written response should be sent to: Lillian C. Aveta, Compliance Officer, New York District Office, Food and Drug Administration, 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 firstname.lastname@example.org.
Ronald M. Pace
New York District