Bamboo Juice LLC in Palmetto, GA was inspected by the U.S. Food and Drug Administration Feb. 28 to March 2, 2018, and found serious violations of the Federal Food, Drug, and Cosmetic Act.
The inspection of the facility revealed serious violations of FDA’s juice Hazard Analysis Critical Control Point (HACCP) regulation, “These violations render your juice products to be adulterated, in that they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or where they may have been rendered injurious to health.”
Additionally, the FDA reviewed product labels collected during their inspection and from the firm’s website; “Based on our review, we have concluded that certain products are in violation of sections 403 and 505(a) of the Act,and regulations implementing the food labeling requirements of the Act,” FDA’s Atlantic district director said in a warning letter to the juice processor.
According to the warning letter, FDA investigators found that in addition to selling raw (i.e., unpasteurized) juice directly to consumers, the firm also sells or distributes raw (i.e., unpasteurized) juice to other business entities. Accordingly, “your facility does not meet the definition of a ‘retail establishment’ and is not exempt from the juice HACCP regulation,” the warning letter said. A retail establishment is defined as “an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers.”
FDA officials observed the following violations:
- The firm’s HACCP plan entitled “Bamboo LLC HACCP and 5-Log Reduction Plan” that covers all their low acid and acidic juices, including “DANDELION”, “GINGERED GREENS”, “CARROT COCONUT”, “CARROT GINGER”, “CILANTRO CELERY”, “CINNAMON YAM”, “DARK GREENS”, “PINEAPPLE JALAPENO”, “SEASONAL GREENS” and “APPLE” does not include control measures that will consistently produce a 5 log reduction of the pertinent microorganism.
Additionally, the FDA noted that they reviewed the firm’s response received via email on March 16, 2018, and their revised “Bamboo LLC HACCP and 5-Log Reduction Plan”, dated March 14, 2018, and found them inadequate; “Your revised plans continue to not include control measures that will achieve a 5 log reduction in the pertinent organisms.”
- The firm’s “Bamboo LLC HACCP and 5-Log Reduction Plan” that covers all the juices the firm processes fail to identify the food hazard of Clostridium botulinum growth and toxin formation that is reasonably likely in their low acid juice products.
The firm noted that it reviewed the firm’s response received via email on March 16, 2018, and their revised “Bamboo LLC HACCP and 5-Log Reduction Plan”, dated March 14, 2018, and found them inadequate; “Your revised HACCP plan continues to not list the food safety hazards that are reasonably likely to occur, including Clostridium botulinum.”
- The FDA reviewed the firm’s product labeling, including product labels and their website in August 2018, where the firm takes orders for the juice and beverage products Vanilla Mint, Turmeric & Beets, Sweet Fennel, Cilantro Celery, Carrot Ginger, Honey Turmeric, Antibiotic, Feel Better, Decongestant, Anti-Inflammatory, Carrot Coconut, and Lemon Ginger. The claims on their labels and/or website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease; “introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.”
Examples of some of the labeling claims that provide evidence that the firm’s products are intended for use as drugs include “Vanilla Mint”, with the product label and webpage “injury healing, respiratory healing,” and “Turmeric & Beets” with the product label and webpage “inflammation tamer, reduce inflammation, anti-inflammatory.” Additional claims include, “arthritis soother,” “best elixir for fighting and/or preventing illnesses,” “[its ingredients] are excellent for fighting candida or yeast found in the body,” and “this elixir helps heal the infection, knock out colds and reduce allergies.”
The FDA noted the firm’s products “are not generally recognized as safe and effective for the above-referenced uses and, therefore, the products are ‘new drugs.’” New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
- The firm’s Spinach Apple product is misbranded because the label fails to declare the statement of identity of the food; “Specifically, Spinach Apple is not an appropriate statement of identity for a food product, in that it is not appropriately descriptive of the foods.”
- The firm processes products containing almonds, an allergen, as they process juice products that do not contain almond and during the FDA’s inspection, “your kitchen manager said that you only rinse the equipment with water between use with products containing almonds and products that do not contain almonds.”
The firm’s procedures do not ensure there is no cross-contact between allergen and non-allergen containing products.
The FDA asked Bamboo LLC to respond in writing within fifteen working days from their receipt of this letter.
“In your response, identify the steps you have taken or will take to correct the above-noted violations and prevent similar ones. In your response, please include the timeframes in which the corrections will be completed and provide any documentation that will assist us in evaluating whether the corrective actions have been made. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the timeframe within which you will complete the corrections.”
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