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Friday, December 18, 2020

FDA Issues Advisory on Green Gorilla Root Juice

FDA issued an Advisory for consumer to avoid Green Gorilla Root Juice.

Green Gorilla Root Juice is made by the Green Gorilla Root Juice Company in St. Louis, MO. It contains Cayenne Pepper, apple juice, and a proprietary blend of natural herbs. One of those "natural herbs" was discovered by FDA to be Yohimbine.

Yohimbine is botanical compound extracted from the bark of the Pausinystalia yohimbe tree. It has been used to treat ED, with varying degree of success. It has been looked at for treating other health issues as well. However, it does have side effects.  "Yohimbine has been associated with heart attacks, seizures and other serious side effects, as well as confusion, dizziness, anxiety, tremors, headaches and skin flushing, and may interact with medications."

In the case of Green Gorilla Root Juice, the ingredient Yohimbine was not declared on the label and product "samples tested by the FDA contained 147 milligrams of Yohimbine in one 16 ounce bottle, which is at least several times higher than what would normally be recommended for use by a physician."

https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-consumers-avoid-green-gorilla-root-juice-due-potentially-harmful-undeclared-ingredient
FDA Advises Consumers to Avoid Green Gorilla Root Juice Due to a Potentially Harmful Undeclared Ingredient
December 18, 2020


Consumers who have recently purchased Green Gorilla Root Juice, sold by Green Gorilla Root Juice, LLC in St. Louis, Missouri.

Product Product: Green Gorilla Root Juice
Packaging Description: Green Gorilla Root Juice is sold as a brown liquid in 16 ounce plastic bottles. The bottles have a green screw lid with white, black and green labeling. Yohimbine, an ingredient confirmed to be in the product by FDA testing, is not listed on the label as required by law.
Distribution Information: The product is offered for sale at greengorillarootjuice.com.

Purpose

The FDA is advising consumers to not drink Green Gorilla Root Juice sold by Green Gorilla Root Juice, LLC in St. Louis, Missouri. The product contains Yohimbine, an ingredient that can be dangerous at the levels found in this product. Green Gorilla Root Juice is offered for sale online at greengorillarootjuice.com. Consumers are advised to discard any Green Gorilla Root Juice immediately. Consumers of these products who are experiencing side effects associated with Yohimbine consumption should contact their healthcare provider and report their symptoms to their local Health Department.

Side Effects Associated with Consuming Yohimbine

Yohimbine has been associated with heart attacks, seizures and other serious side effects, as well as confusion, dizziness, anxiety, tremors, headaches and skin flushing, and may interact with medications.

Summary of Problem and Scope

Laboratory tests conducted by the FDA indicated Green Gorilla Root Juice contains the undeclared ingredient Yohimbine. The problem was discovered as part of a joint regulatory investigation by the FDA and the Missouri Department of Health and Senior Services (DHSS). Product samples tested by the FDA contained 147 milligrams of Yohimbine in one 16 ounce bottle, which is at least several times higher than what would normally be recommended for use by a physician.

The product is offered for sale at greengorillarootjuice.com. The FDA and DHSS are working to ascertain if there are other sales outlets, but these efforts have been delayed by the firm’s lack of cooperation. After multiple unsuccessful attempts to contact the firm to inform them of the sample results, the FDA and DHSS attempted to conduct an inspection on December 16, 2020, but they were not permitted access.

FDA Actions

The FDA will continue to work with DHSS to contact the firm, and to notify consumers who purchased the product and request that they immediately dispose of it.

Recommendations for Consumers

Consumers who have Green Gorilla Root Juice should discard it.

Consumers who have symptoms of potential side effects from Yohimbine should contact their health care provider to report their symptoms and receive care.

To report a complaint or adverse event (illness or serious allergic reaction), you can

Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.

Complete an electronic Voluntary MedWatch form online.

Complete a paper Voluntary MedWatch form that can be mailed to FDA.

You may also notify the FDA if you have purchased Green Gorilla Root Juice from an outlet other than the firm’s website.

Visit www.fda.gov/fcic for additional consumer and industry assistance.

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