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WARNING LETTER

Bamboo LLC MARCS-CMS 557742 — 11/10/2018

Bamboo LLC - 557742 - 10/11/2018

Product:
Food & Beverages
Juice
Beverage Bases/Conc/Nectar
HACCP
Sanitation

Recipient:
Recipient Name
Kelley Sibley Henry
Recipient Title
Owner
Bamboo LLC
Bamboo LLC

502 Toombs Street

Palmetto, GA 30268-1217
United States

Issuing Office:
Atlanta District Office

United States


October 11, 2018

OVERNIGHT VIA UNITED PARCEL SERVICE

Kelley Sibley Henry, Owner
Bamboo, LLC
502 Toombs Street
Palmetto, GA 30268-1217

Reference: CMS Case # 557742

WARNING LETTER

Dear Mrs. Henry:

On February 28 to March 2, 2018, an investigator from the United States Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 502 Toombs Street in Palmetto, GA, and found serious violations of section 402 of the Federal Food, Drug, and Cosmetic Act (the Act).

In addition, we reviewed your product labels collected during our inspection and your firm’s website at the internet address, https://bamboojuices.com. 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, 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 FDA’s website at www.fda.gov.

Adulterated Juices

The inspection of your facility revealed serious violations of FDA’s juice Hazard Analysis Critical Control Point (HACCP) regulation, found at Title 21 of the Code of Federal Regulations, Part 120 (21 CFR 120).  These violations render your juice products to be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or wherby they may have been rendered injurious to health. You may find the juice HACCP regulation and FDA’s Juice HACCP Hazards and Controls Guidance at https://www.fda.gov/food/guidanceregulation/haccp/ucm2006803.
 
The inspection identified that in addition to selling raw (i.e., unpasteurized) juice directly to consumers, you also sell or distribute 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. 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.” (21 CFR 120.3(l)).

The inspection resulted in the issuance of a FORM FDA 483 (FDA 483), Inspectional Observations, at the conclusion of the inspection on March 2, 2018, which lists the objectionable conditions found by our investigator at your firm. A copy of the FDA 483 is attached to this correspondence. We acknowledge receipt of your firm’s written response to the FDA 483; however, after reviewing the response, we continue to have concerns, which we outline below.

The significant violations noted as a result of the inspection of your firm include, but may not be limited to, the following:
 
  1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5 log reduction of the pertinent microorganism, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). With the exception of citrus juice processors, all juice processors must meet the minimum 5 log reduction requirements of the regulation through treatments that are applied directly to the juice (21 CFR 120.24(b)). Your HACCP plan entitled “Bamboo LLC HACCP and 5-Log Reduction Plan” that covers all your 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.  Specifically, while your plan includes three critical control points as processing, bottling and cooler packaging and delivery temperatures, none of the critical control points identify and/or include a microbial reduction step. In addition, your “5-log reduction program”, attached to your HACCP plan, indicates the juice is not subject to any treatment that would ensure a 5 log reduction and is therefore not a suitable process to comply with the minimum 5 log reduction requirement for any of your juices.

Once you have identified the pertinent microorganism(s) in each of your juices and the appropriate controls, you must include these controls as critical control points in your HACCP plan. For low acid juices, which pose a significant hazard for Clostridium botulinum growth and toxin formation due to the high pH levels, FDA recommends that processors incorporate validated control measures for all Clostridium botulinum into their HACCP plans that will ensure that Clostridium botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept unrefrigerated or exposed to unrefrigerated conditions for extended time periods during distribution and/or by the end users/consumers. For additional information related to microbiological concerns in low acid juice products, please reference this FDA guidance document:

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072481.htm  

For more information on control measures for other biological hazards and identifying the pertinent microorganism, please see FDA’s Hazards and Controls Guide, Section V:

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm072557.htm

We have reviewed your response received via email on March 16, 2018 and your revised “Bamboo LLC HACCP and 5-Log Reduction Plan”, dated March 14, 2018, and find them inadequate. Your revised plans continue to not include control measures that will achieve a 5 log reduction in the pertinent organisms.    
 
  1. Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A “food hazard" is defined in 21 CFR 120.3(g) as "any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your “Bamboo LLC HACCPand 5-Log Reduction Plan” that covers all the juices you process fails to identify the food hazard of Clostridium botulinum growth and toxin formation that is reasonably likely in your low acid juice products.  While this document includes references to various pathogenic organisms, it does not specifically reference Clostridium botulinum growth and toxin formation, which is a reasonably likely hazard associated with your low acid juice products. 

We have reviewed your response received via email on March 16, 2018 and your revised “Bamboo LLC HACCP and 5-Log Reduction Plan”, dated March 14, 2018, and find them inadequate. Your revised HACCP plan continues to not list the food safety hazards that are reasonably likely to occur, including Clostridium botulinum.

Unapproved New Drugs

The FDA reviewed your product labeling, including product labels and your website at the Internet address https://bamboojuices.com in August 2018, where you take 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 your labels and/or 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 labeling claims that provide evidence that your products are intended for use as drugs include:
Vanilla Mint
  • Product label: “injury healing;” “respiratory healing”
  • Webpage: “injury healing”


Turmeric & Beets
  • Product label and webpage: “inflammation tamer;” “reduce inflammation;” “anti-inflammatory”
Sweet Fennel
  • Product label and webpage: “headache reliever;” “reduces heartburn”
Cilantro Celery
  • Product label and webpage: “heavy metal detoxifying”
Carrot Ginger
  • Product label: “decongestant”
Honey Turmeric
  • Product label: “anti-inflammatory;” “disease preventing”
Antibiotic
  • Product label: the name of the product; “this elixir helps heal infection, knock out colds and reduce allergies”
  • Webpage: “infection healing;” “allergy reducing;” “[its ingredients] are excellent for fighting candida or yeast found in the body”
Feel Better
  • Product label: “knock out a cold and reduce inflammation”
  • Webpage: “inflammation fighting;” “best elixir for fighting and/or preventing illnesses “
Decongestant
  • The name of the product
  • Webpage: “mucus eliminating;” “sinus clearing”
Anti-Inflammatory:
  • Product label and webpage: the name of the product; “the most potent anti-inflammatory remedies”
Carrot Coconut
  • Product label and/or webpage: “arthritis soother;” “anti-inflammatory”
Lemon Ginger
  • Webpage: “natural remedy for kicking colds and clearing sinuses” 

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.

Misbranded Food

Additionally, your Spinach Apple product is misbranded under section 403 of the Act (21 U.S.C. § 343) as follows:
 
  1. Your Spinach Apple juice product is misbranded within the meaning of 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] 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, as required by 21 CFR 101.3(b). For example:
    1. The name of the product fails to include the term “juice,” “beverage,” “juice cocktail,” “smoothie,” or other term that is descriptive of the nature of the products.
    2. The name of the food does not comply with 21 CFR 102.33(b), (c), and (d) because it is a blend of juices that names one or more juice other than in the ingredient list but the name fails to 1) declare those names in descending order of predominance by volume unless the name specifically shows that the juice with the represented flavor is used as a flavor in accordance with 21 CFR 102.33(b); 2) indicate that the represented juices are not the only juices present in accordance with 21 CFR 102.33(c); 3) indicate that the named juice which is not the predominant juice (i.e. spinach is less predominant than apple) is present as a flavor or flavoring or include the amount of the named juice and declared in a 5-percent range in accordance with 21 CFR 102.33(d).
    3. The statements of identity must be listed on the principal display panel of the food package, as required by 21 CFR 101.3(a). The principal display panel is the part of the label that is most likely to be displayed under customary conditions of retail sale (i.e., the front of the bottle), 21 CFR 101.1. The bottle cap is not the principal display panel.
  2. Your Spinach Apple product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that it purports to be a beverage containing vegetable or fruit juice, but does not bear a statement on the product label of the total percentage of such fruit or vegetable juice contained in the food in accordance with 21 CFR 101.30.
Additionally, the ingredient statement is not located on the label in accordance with 21 CFR 101.4. The ingredient statement must be listed on either the principal display panel or the information panel of the food package (21 CFR 101.4(a)(1)). The bottle cap is not the principal display panel.
  1. Your Spinach Apple product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product label fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
  2. Your Spinach Apple product is misbranded within the  meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the net quantity of contents declaration does not meet placement and prominence requirements of 21 CFR 101.7(e) and 101.7(f). The declaration is not a distinct item on the PDP.
This letter is not an intended to be an all-inclusive list of violations that exist at your facility or in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and all applicable laws and regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action by FDA without further notice, including seizure or injunction.

We also offer the following comments:

You process products containing almonds, an allergen, on the same equipment and filter bag as you process juice products that do not contain almonds. During our inspection, your kitchen manager said that you only rinse the equipment and filter bag with water between use with products containing almonds and products that do not contain almonds. Your procedures do not ensure there is no cross contact between allergen and non-allergen containing products.

Additionally, if you are re-using glass bottles returned by your customers to package finished products, you should be aware of the potential for allergen cross contact from the returned bottles and the need to adequately clean and sanitize all reusable containers.

Further, we note that the Spinach Apple label webpage bears the statements, “This product may contain traces of nuts. This product was produced on shared equipment that processes nuts.” FDA has consistently maintained that the use of advisory labeling, such as “may contain” or “made on equipment…” is not an acceptable substitute for food allergen control procedures to prevent cross contact.

For your information, FDA finalized new requirements for nutrition labeling on May 27, 2016. The new Nutrition Facts label includes updates to the required nutrient declarations and formatting requirements. Manufacturers may begin revising labels now to meet the new requirements. FDA extended the compliance dates for the Nutrition Facts label final rule and the Serving Size final rule, from July 26, 2018 to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales would receive an extra year to comply – until January 1, 2021. For more information on the new requirements, please see http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm385663.htm

Please respond to this office in writing within fifteen (15) working days from your 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. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.


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-inspecton-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 reply should be directed to Lakisha Morton, Compliance Officer, U.S. Food and Drug Administration, Office of Human & Animal Food Operations, Division East III, 60-8th Street NE, Atlanta, GA 30309.  If you have questions concerning this letter, you may contact Mrs. Morton at 404-253-1285, at lakisha.morton@fda.hhs.gov,  or write her at the noted mailing address.

Sincerely,
/S/
Ingrid A. Zambrana
Program Division Director                                                                                                                               
Office of Human and Animal Foods
Division East III (Georgia, North Carolina, and South Carolina)
Office of Regulatory Affairs
U.S. Food and Drug Administration       


cc:
Natalie Adan, Division Director
Food Safety Division
Georgia Department of Agriculture
19 Martin Luther King, Jr. Dr. S.W.
Atlanta, GA 30334