---

---

---

WARNING LETTER
FY22-HAFE6-05 CMS 624051

March 11, 2022

Dear Mr. Herzog:

This is to advise you that the Food and Drug Administration (FDA) reviewed your Amazon.com storefronts at https://www.amazon.com/stores/Biotta/page/9B960DEE-B174-4936-974D-A819B9769B6B?ref_=ast_bln and https://www.amazon.com/juiceperformer?&_encoding=UTF8&tag=biottajuices-20&linkCode=ur2&linkId=d3d1183c057052af439e1da624875d15&camp=1789&creative=9325 in November – December 2021, and has determined that you take orders there for the products Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice, Biotta Elderberry Juice, Biotta Golden Beet Juice Blend with Turmeric, Biotta Celery Root Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cherry Juice, Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice. We also reviewed your website at www.drinkbeetjuice.com, which directs consumers to your websites at www.biottajuices.com, and www.juiceperformer.com, both of which direct consumers to your Amazon.com storefronts to purchase your products. The claims on your websites 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 website claims that provide evidence that your products are intended for use as drugs include:

Biotta product webpage claims
• Biotta Apple Beet Ginger Juice “Products” page (http://www.biottajuices.com/products/apple-beet-ginger-juice/)
- “Ginger: may … protect against Alzheimer’s”
- “Helps fight cancer…Apple: reduces the risk of colon and lung cancer¹…Beet: helps fight breast cancer, also protects from pancreatic, prostate cancers…Ginger: lowers the risk of breast, ovarian, pancreatic cancers”
- “Apple: prevents chronic diseases … Beet: reduces blood pressure … Ginger: calms indigestion and reduces nausea”

• Biotta Beet Juice “Products” page (http://www.biottajuices.com/products/beet-juice/)
- “Helps reduce blood pressure … Hypertension/AHA study shows 7% reduction in blood pressure … Contributes to a reduction in arterial stiffness”
- “…may lower risk of stroke…
- “Improved mobility for patients with COPD [chronic obstructive pulmonary disease]… Improved muscle power in patients with heart failure”
- “May help prevent Type 2 Diabetes”
- “Powerful … anti-inflammatory”

• Biotta Carrot Juice “Products” page (http://www.biottajuices.com/products/carrot-juice/)
- “Prevents … acne …”
- “Lowers risk of cardiovascular disease”
- “Reduces the risk of stroke”
- “Reduces breast cancer risk…”
- “When the liver functions well, it prevents the accumulation of fat and aids in its rapid digestion, preventing … obesity”

• Biotta Elderberry Juice “Products” page (http://www.biottajuices.com/products/elderberry-juice/)
- “[E]lderberry juice…has been effective in relieving colds and flu…”
- “Treats respiratory illness…May help reduce swelling in mucous membranes…antiviral properties of elderberries were able to effectively inhibit the H1N1 virus, and offered similar effects to prescription medications like Tamiflu”
- “Flavonoids in elderberries … may help prevent damage to the body’s cells … Lowers cholesterol …”

• Biotta Golden Beet Juice Blend with Turmeric “Products” page (http://www.biottajuices.com/products/golden-beet-juice-blend-turmeric/)
- “Improves heart health…Reduces blood pressure…Stabilizes blood sugar…Assists in fighting against heart disease”
- “Provides powerful anti-inflammatory effects … May be effective in lowering bad cholesterol”

• Biotta Celery Root Juice “Products” page (http://www.biottajuices.com/products/celery-juice/)
- “Acts as a diuretic, helping neutralize pH balance and stimulating kidney function, ridding the body of toxins and allowing the body to resist disease … Reduces formation of kidney stones”
- “Acts as an anti-inflammatory … Used to reduce effects of asthma”

• Biotta Breuss Vegetable Juice “Products” page (http://www.biottajuices.com/products/breuss-vegetable-juice/)
- “Ideal for Breuss cancer treatment…”
- “Featured in Dr. Breuss’ book – The Breuss Cancer Cure: Advice for the Prevention and Natural Treatment of Cancer, Leukemia, and Other Seemingly Incurable Diseases”

• Biotta Tart Cherry Juice “Products” page (http://www.biottajuices.com/products/tart-cherry-juice/)
- “Ideal for reducing inflammation …”
- “Prevents gout…Tart cherry juice can combat gout, a type of arthritis that causes repeated attacks of intense pain and swelling”
- “Good source of Potassium … Consuming foods rich in potassium may help lower blood pressure and decrease the risk of kidney stones”

Juice Performer webpage claims
On a page titled “Science” in the “Beet” section of the Juice Performer website (http://www.juiceperformer.com/beet-performer/science/):

Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice
- “Beet juice also lowers blood pressure…and reduces inflammation in the body”
- “Research has shown that a daily inorganic nitrate dose (like from Beet juice) can be as effective as medical intervention in reducing blood pressure… Some of the findings include:
     Drinking 8 oz of Beet juice lowered systolic blood pressure by an average of 4-5 points
     Beet juice contributed to a reduction in arterial stiffness as well as a sustained reduction in blood pressure. This was found to be as effective as prescription medication.
     Seniors With Heart Failure Benefit From Beetroot Juice”
- “Patients with COPD were able to improve their exercise function after drinking Beet juice.”

Your Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice, Biotta Elderberry Juice, Biotta Golden Beet Juice Blend with Turmeric, Biotta Celery Root Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cherry Juice, Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice 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)]. 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 products Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice, Biotta Elderberry Juice, Biotta Golden Beet Juice Blend with Turmeric, Biotta Celery Root Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cherry Juice, Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, 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 Biotta Apple Beet Ginger Juice, Biotta Beet Juice, Biotta Carrot Juice, Biotta Elderberry Juice, Biotta Golden Beet Juice Blend with Turmeric, Biotta Celery Root Juice, Biotta Breuss Vegetable Juice, Biotta Tart Cherry Juice, Juice Performer Beet Juice with Pineapple Juice, Juice Performer Beet Juice with B12, and Juice Performer Beet Juice with Passion Fruit Juice 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)].

This letter is not intended to be an all-inclusive statement of violations that may 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.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to the following address: U.S. Food and Drug Administration, Alecia Marson-Acting Compliance Officer, 550 W. Jackson Blvd., Suite 1500 Chicago, IL 60661. If you should have any questions regarding any issue in this letter, please contact Alecia Marson, Acting Compliance Officer, at (414) 326-3973 or email [email protected].

Sincerely,
/S/

William R. Weissinger, MS
District Director | FDA Chicago District
Program Division Director
Office of Human and Animal Food Operations East Division 6

____________________________________

1 Here and throughout the remainder of the letter, citations have been removed where they appear on your website.