Inspections, Compliance, Enforcement, and Criminal Investigations

Goodlife Juices 8/5/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
14-PHI-16
 
 
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
 
August 5, 2014
 
Sherry R. Quinn, Owner
Goodlife Juices, LLC
2312 Main Street
Pittsburgh, PA 15215
 
Dear Ms. Quinn:
 
The U.S. Food and Drug Administration conducted an inspection of your juice processing facility, located at 2312 Main Street, Pittsburgh, PA on December 4, 2013 through January 2, 2014. During our inspection you provided our investigator with five of your finished product juice labels. These labels bear the Internet address of your website http://www.goodlifejuices.com. The inspection and our review of your product labeling revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA’s regulations at www.fda.gov. Additionally, you can find The Juice Hazard Analysis and Critical Control Point (HACCP) Controls Guidance, First Edition at the following link: 
 
Unapproved New Drugs:
 
FDA reviewed your website at the Internet address http://www.goodlifejuices.com in April of 2014 and has determined that you take orders there for the products GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), PAM Juice, and ReBeet (also known as Beet-Reboot), which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs 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.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
From your webpage titled “Essential Green Juice GOODLife Juices” under the “Juices” tab:
 
    “Kale…combats anemia…and skin disorders…”
    “Cucumber… helps regulate blood pressure…”
    “Ginger…combating…inflammation, and respiratory infections.”
 
From your webpage titled “Green Immunity GOODLife Juices” under the “Juices” tab:
 
    “Kale…combats anemia…and skin disorders.”
    “Broccoli…Perfect combination of anti-inflammation…”
    “Apple…anti-inflammatory…”
 
From your webpage titled “PAM Juice GOODLife Juices” under the “Juices” tab:
 
    “PAM Juice…Pineapples contains bromelain, an anti-inflammatory agent that helps fight heart disease and arthritis…Apples contain antioxidants that cleanse…..and fight arthritis…”
 
From your webpage titled “Beet-Reboot GOODLife Juices” under the “Juices” tab:
 
    “Ginger…combating...inflammation.”
 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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, because your GOODLife Brand PAM Juice product is 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 this drug safely for its intended purpose. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].   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)].
 
Juice HACCP:
 
Even if your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), PAM Juice, and ReBeet (also known as Beet-Reboot) products did not have therapeutic claims which make them unapproved new drugs, these products and the other juice products that you manufacture would still be adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. During our inspection of your juice processing facility we found that you have serious violations of the Juice HACCP regulation, Title 21, Code of Federal Regulations (CFR), Part 120, and the Current Good Manufacturing Practice regulation for foods, Title 21, CFR Part 110. In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 21 CFR Part 120, or otherwise operate in accordance with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) the Act).
 
Our inspection resulted in the issuance of a Form FDA-483, Inspectional Observations (FDA-483) which cited your facility for failure to have a juice HACCP plan and conduct a hazard analysis for the juice products that you manufacture. However, immediately after the issuance of the FDA-483, you provided our investigator with a document entitled “GOODLife Juices HACCP PROCEDURES/STEPS:”and informed him that this document was your Juice HACCP plan. We have reviewed your HACCP plan and the following are significant juice HACCP violations documented during our inspection and also take into account the Juice HACCP plan that you provided our investigator.   
 
1.    You must include in your hazard analysis and HACCP plan, control measures that will consistently 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 or moderate abuse conditions, to comply with 21 CFR 120.24(a). However your HACCP plan for your GOODlife brand “Essential,”; “Immunity”; “Beet”; and “Innergy” fruit and vegetable juice products does not provide controls to ensure a 5-log reduction of the pertinent microorganisms. Your firm manufactures, packages, and distributes these products without a 5-log reduction process being applied directly to these juice products in your facility.
 
2.    Your hazard analysis and HACCP plan must list the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a) and (b)(1). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical or physical agent that is reasonable likely to cause illness or injury in the absence of its control.” However, your firm’s HACCP plan for your GOODlife brand “Essential”; “Immunity”; “Beet”; and “Innergy” fruit and vegetable juice products, packaged in plastic bottles does not list the pertinent food safety hazards of foreign objects and microbiological hazards  that are of specifically related to your juice products and are of the greatest concern. Once you have identified these hazards, you must also include control measures in your HACCP plan for the monitoring of these hazards. For information to control these food safety hazards, you may refer to the following link or The Juice HACCP Controls Guidance, First Edition: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072557.htm.
 
Misbranded Food
 
Additionally, even if your “GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), PAM Juice, and ReBeet (also known as Beet-Reboot) products did not have therapeutic claims which make them unapproved new drugs, they would still be misbranded foods within the meaning of section 403 of the Act [21 U.S.C. § 343]. Further, your Innergy product and un-named juice (referred to as Brazil Milk) products are misbranded under section 403 of the Act. 
 
Website:
 
1.    Your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), and ReBeet (also known as Beet-Reboot) products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because your website, http://www.goodlifejuices.com, bears nutrient content claims, but the products do not meet the requirements to make these claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)].
 
Specifically, your website bears the following unauthorized nutrient content claims:
 
From your webpage titled “Green Immunity GOODLife Juices” under the “Juices” tab:
 
    “Green Immunity…Kale, an excellent source of…calcium, vitamin A and iron, a…..Broccoli: Rich in vitamins A, C, and K…
 
From your webpage titled “Beet-Reboot GOODLife Juices” under the “Juices” tab:
 
    “Beet-Reboot… Carrot …great source of beta carotene. The high vitamin A content in carrots…Celery: Rich in vitamins B and C.
 
From your webpage titled “Essential Green Juice GOODLife Juices” under the “Juices” tab:
 
    “Essential Green Juice….Kale: an excellent source of…calcium, vitamins A and C plus iron…..Spinach: This alkalizing vegetable is rich in manganese, folate, iron, and magnesium …”
 
In accordance with 21 CFR 101.54(b), the terms “high,” “rich in,” or “excellent source of” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 20 percent or more of the Daily value (DV) per reference amount customarily consumed (RACC). Because your product labeling fails to declare any nutrients levels, it is not clear whether your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), and ReBeet (also known as Beet-Reboot) products have the required minimum percentages of the DV per RACC required under 21 CFR 101.54(b) for the use of the defined terms “high,” “rich in,” and “excellent source.” Therefore, these products are misbranded under section 403(r)(1)(A) of the Act and section 403(q) of the Act [21 U.S.C. § 343(q)], because they do not provide information under 21 CFR 101.9(c)(8)(ii) on the levels of referenced vitamins and minerals, and under 21 CFR 101.13(n) for nutrition labeling generally. Your ReBeet (also known as Beet-Reboot) product is also misbranded under section 403(r)(1)(A) of the Act because FDA has no regulation authorizing the use of the term “great source” in the nutrient content claim “Carrot…great source of beta carotene” on your website. In the context of your labeling, the term “great source” is an unauthorized synonym for a “high” nutrient content claim.  Even if the term “great source” was an authorized synonym for “high,” because the labeling for your ReBeet (also known as Beet-Reboot) product does not declare any nutrients, it is not clear whether the product has the required minimum percentage of the DV per RACC to make a “high” nutrient content claim.
 
Your website also bears unauthorized nutrient content claims for your GOODLife brand Essential (also known as Essential Green Juice) and Immunity (also known as Green Immunity) products for the substance chlorophyll, for which there is no established DV.
 
Specifically, the unauthorized claims relating to chlorophyll on your website are as follows:
 
From your webpage titled “Green Immunity GOODLife Juices” under the “Juices” tab:
 
    “Kale, an excellent source of chlorophyll…”
 
From your webpage titled “Essential Green Juice GOODLife Juices” under the “Juices” tab:
 
    “Kale, an excellent source of chlorophyll…”
 
FDA has issued a regulation specifying criteria for the use of the nutrient content claim “excellent source,” which is an authorized synonym of “high,” in food labeling (21 CFR 101.54(b)(1)).   As noted above, this regulation requires a food that bears this claim to contain 20 percent or more of the DV of the nutrient per RACC. However, this regulation does not authorize your claims because there is no DV for chlorophyll. Therefore, the use of the term “excellent source” to characterize the level of chlorophyll in yourGOODLife brand Essential (also known as Essential Green Juice) and Immunity (also known as Green Immunity) products misbrands these products under section 403(r)(1)(A) of the Act. 
 
We note that there are alternative ways to convey the amount of nutrients in your products to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). If you want to seek authorization to use your current claims, you may submit a petition requesting FDA to authorize new nutrient content claims (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.  
 
Product Labels:
 
1.    Your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), Innergy, ReBeet (also known as Beet-Reboot), and un-named juice (referred to as Brazil Milk) products are misbranded under section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the product labels lack a statement of identity in accordance with 21 CFR 101.3. The naming of beverages that contain fruit or vegetable juice must be in accordance with 21 CFR 102.33.
 
2.    Your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), Innergy, ReBeet (also known as Beet-Reboot), and un-named juice (referred to as Brazil Milk) products are misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the total percentage of fruit or vegetable juice in accordance with 21 CFR 101.30. Beverages that purport to contain juice (fruit or vegetable juice) must declare the % juice. Included are beverages that purport to contain juice by way of label statements, by pictures of fruits or vegetables on the label, or by taste and appearance causing the consumer to expect juice in the beverages. The % juice declaration must be on the information panel (for packages with information panels). If the package does not have an information panel, the percent juice must be placed on the PDP in a type size not less than that required for the net contents declaration and placed near the name of the food, in accordance with 21 CFR 101.30(e) and (g).   
 
Your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), Innergy, ReBeet (also known as Beet-Reboot), and un-named juice (referred to as Brazil Milk) products are also misbranded under section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and their labels fail to list the common or usual name of each ingredient in accordance with 21 CFR 101.4. Specifically, the ingredients listed on the principal display panels of your products are not accurate because the products actually contain juices or liquids derived from these ingredients, not the entire named ingredient. Our inspection indicates that the ingredients are cold-pressed juices which are subsequently screened, not pureed or processed by another means whereby the entire ingredient would be found in the product. Furthermore, we note that there are some inconsistencies between the list of ingredients on the labels, the internet labeling, and the HACCP procedures/steps. Your ingredient statement declared on the product label and labeling should accurately declare only the ingredients that are actually in the product.
 
3.    Your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), Innergy, ReBeet (also known as Beet-Reboot), and un-named juice (referred to as Brazil Milk) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the products fail to provide nutrition information in accordance with 21 CFR 101.9. 
 
4.    Your GOODLife brand Essential (also known as Essential Green Juice), Immunity (also known as Green Immunity), Innergy, ReBeet (also known as Beet-Reboot), and un-named juice (referred to as Brazil Milk) products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)], in that the labels fail to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(a).
 
This letter is not meant to be an all-inclusive list of the violations that may exist in connection with your products or their labeling.  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, including seizure and/or injunction.
 
We note that the reference to your GOODLife brand un-named juice as “Brazil Milk” on your website at http://www.goodlifejuices.com may potentially be misleading because it may imply that your product contains milk. Milk is a standardized food defined as the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows [21 CFR 131.110].
 
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection, 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 reinspection-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 reinspection-related costs.
 
You should respond in writing within fifteen (15) working days from your receipt of this letter with the actions you plan to take in response to this letter.  You should include in your response documentation such as a revised Juice HACCP plan, revised product labels and website labeling, 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.
 
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by email at Lynn.Bonner@fda.hhs.gov
 
                                                                       
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District
 
cc:     
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
Attention: Dr. Lydia Johnson, Director
2301 North Cameron Street
Harrisburg, PA 17110-9408

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