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WARNING LETTER

Summit Beverage Group, LLC MARCS-CMS 432076 —


Recipient:
Recipient Name
Mr. Geoffrey S. Soares
Summit Beverage Group, LLC

211 Washington Ave.

Marion, VA 24354
United States

Issuing Office:
Baltimore District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707

 

WARNING LETTER
CMS# 432076
 
 
October 17, 2014
 
 
Via UPS
 
Mr. Geoffrey S. Soares, C.E.O.
Summit Beverage Group, LLC
211 Washington Ave.
Marion, VA 24354
 
 
Dear Mr. Soares:                                                                                                                           
 
We inspected your firm, a contract manufacturer of a variety of beverages and dietary supplements, located at 211 Washington Avenue in Marion, VA on April 23, 24, 29, May 1, and 7, 2014. Based on our inspection and subsequent review of your product labeling collected during the inspection, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.
 
The inspection and our review of your products’ website and product labeling collected during the inspection revealed the following significant violations:
 
Unapproved New Drugs
 
Based on our review of your product labeling, we have determined that your AMAZON coconut water + rooibos tea (infused with acai), AMAZON coconut water + white tea (infused camucamu), and AMAZON urucu water (infused with pomegranate) products are promoted for conditions that cause them to be drugs within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].  The therapeutic claims on the labeling establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. 
 
Examples of claims in your product labeling that provide evidence that your products are intended for use as drugs include, but not limited to the following:
 
1)    AMAZON coconut water + rooibos tea (infused with acai) product label:
  • “Acai’s…benefits include protecting against cancer, cardiovascular disease, arthritis pain, Parkinson’s disease, and Alzheimer’s disease.” 
2)    AMAZON coconut water + white tea (infused with camucamu) product label:
  • “Camu camu is known for healing connective tissue…”
3)    AMAZON urucu water (infused with pomegranate) product label:
  • “[A]n all natural form of…anti-inflammatory, antiseptic…”
These products are not generally recognized as safe and effective for the above referenced uses and, therefore, each of these product is a “new drug” 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, your AMAZON coconut water + rooibos tea (infused with acai) 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 the drug safely for its intended uses.  Thus, this product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use.  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)].
 
Misbranded Food
 
Even if your AMAZON coconut water + rooibos tea (infused with acai) and AMAZON coconut water + white tea (infused with camucamu) 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 AMAZON coconut water + green tea (infused with cupuacu) and Cell-nique Super Green Pomegranate products are misbranded under section 403 of the Act.
 
1.    Your AMAZON coconut water + rooibos tea (infused with acai), AMAZON coconut water + green tea (infused with cupuacu), AMAZON coconut water + white tea (infused with camucamu), and Cell-nique Super Green Pomegranate products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labels bear 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)].
 
The claims on your AMAZON coconut water + rooibos tea, AMAZON coconut water + green tea, AMAZON coconut water + white tea, and Cell-nique Super Green Pomegranate product labels include:
 
AMAZON coconut water + rooibos tea:
  • “Packed with antioxidants…”
  • “ANTIOXIDANT RICH”
AMAZON coconut water + green tea:
  • “Rich in antioxidants, phytonutrients and flavonoids…”
  • “ANTIOXIDANT RICH”
AMAZON coconut water + white tea:
  • “Rich in anti-oxidants …”
  • “ANTIOXIDANT RICH”
Cell-nique Super Green Pomegranate:
  • “Antioxidant & Phytonutrient Rich”
Your product labels bear antioxidant nutrient content claims but fail to comply with the requirements for using such claims. Nutrient content claims using the term “antioxidant” must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim, as required by 21 CFR 101.54(g)(1), and these nutrients must have recognized antioxidant activity, as required by 21 CFR 101.54(g)(2). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), as required by 21 CFR 101.54(g)(3). For example, to bear the claim “high in antioxidant vitamin C,” the product must contain 20% or more of the RDI for vitamin C under 21 CFR 101.54(b). Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term “antioxidant” or “antioxidants” may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity, as required by 21 CFR 101.54(g)(4). The above quoted antioxidant claims on your product labels are nutrient content claims because they characterize the level of antioxidants in your products, but they do not comply with 21 CFR 101.54(g)(4) because they do not include the names of the nutrients that are the subject of the claim. 
 
FDA has issued a regulation specifying criteria for the use of the nutrient content claims “rich” in food labeling [21 CFR 101.54(b)(1)]. This regulation requires a food that bears this claim to contain 20 percent or more of the Daily Value (DV) of the nutrient per reference amount customarily consumed (RACC). However, this regulation does not authorize your claims because there are not DVs for phytonutrients and flavonoids. Therefore, the use of the term “Rich in…phytonutrients and flavonoids…” and “Phytonutrient Rich” to characterize the level of phytonutrients and flavonoids in your AMAZON coconut water + green tea and Cell-nique Super Green Pomegranate products misbrand your products under section 403(r)(1)(A) of the Act.
 
We note that there are alternative ways to convey the amount of phytonutrients and flavonoids 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 claim, you may submit a petition requesting FDA to authorize a new nutrient content claim for phytonutrients and/or flavonoids (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.
           
In addition, your Cell-nique Super Green Pomegranate product bears the “low calorie” statement. A low calorie claim may be made if a food with a reference amount customarily consumed (RACC) greater than 30 grams (g) or greater than 2 tablespoons does not provide more than 40 calories per RACC [21 CFR 101.60(b)(2)(i)(A)]. The RACC established for beverages is 8 fl. oz. (240 mL). See 21 CFR 101.12(b) (Table 2, Beverages, Carbonated and noncarbonated beverages, wine coolers, water). The nutrition information for this product states that there are 84 calories per bottle (12 fl. oz. 355 mL) of product; this equals about 56 calories per RACC. Therefore, your product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product is not a low calorie food. 
 
2.    Your AMAZON coconut water + rooibos tea (infused with acai), AMAZON coconut water + green tea (infused with cupuacu), and AMAZON coconut water + white tea (infused with camucamu) products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. There is not a format provided by 21 CFR 101.9 that permits only some of the nutrients to be declared per serving and per container. If you choose to provide dual columns, it must be provided for all nutrients. Additionally, Vitamin B3 and Vitamin B5 are not declared in the nomenclature established in 21 CFR 101.9(c)(8)(iv).
 
3.    Your Cell-nique Super Green Pomegranate product is misbranded within the meaning of Section 403(i)(1)of the Act [21 U.S.C. § 343(i)(1)] because there is no statement of identity on the principal display panel, as required under 21 CFR 101.3. Specifically, “Super Green” is not a standardized food name, a common or usual name or an appropriately descriptive term for the product.
 
4.    Your Cell-nique Super Green Pomegranate product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is a product that purports to be a beverage containing vegetable or fruit juice but fails to contain a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food, as required by 21 CFR 101.30. Beverages that purport to contain juice (fruit or vegetable juice) must declare the percentage by the words “Contains _ percent (or %) _ juice” or a similar phrase with the first blank filled in with the percentage of the juice and the second blank (if used) filled in with the name of the particular fruit or vegetable (e.g., “Contains 50 percent apple juice” or “50 percent juice”) juice as required by 21 CFR 101.30(b)(1).  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).      
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. It is your responsibility to ensure that all your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including seizure and/or injunction.
 
In addition, we have the following comments:
 
1.    The labels for your AMAZON coconut water + rooibos tea (infused with acai), AMAZON coconut water + green tea (infused with cupuacu), and AMAZON coconut water + white tea (infused with camucamu) products all list “Reverse Osmosis Water” as the first ingredient.; however, your firm does not have the equipment or capability to produce water by reverse osmosis. Your labels must accurately reflect the ingredients used.
 
2.    Your Cell-nique Super Green Pomegranate product bears the claim “Gluten Free.” However, the ingredient statement declared “Barley” as an ingredient. Barley is a grain known to contain gluten. Your “Gluten Free” claim may be misleading to consumers who are seeking products that are gluten-free or contains no gluten. The labeling claim that a food is “gluten-free” means that the food bearing the claim in its labeling does not contain any of the following ingredients:  
  • An ingredient that is a gluten-containing grain; or
  • An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten. For example, “wheat flour” is an ingredient made from wheat that has not been processed to remove the naturally occurring gluten in wheat. Therefore, wheat flour cannot be used as an ingredient to make a food labeled “gluten-free;” or
  • An ingredient that is made from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten. For example, wheat starch is an ingredient made from wheat that has been processed to remove gluten. However, the use of this ingredient must result in under 20 parts per million gluten in the finished food for the food to be labeled “gluten-free.”  
A “gluten-free” claim also can appear on the labels of foods that inherently do not contain gluten (e.g. raw carrots and grapefruit juice).
 
Additionally, any unavoidable presence of gluten in a food bearing a “gluten-free” claim, whether manufactured to be gluten-free or inherently free of gluten, must be below 20 ppm gluten. This means that foods may not use the claim if they contain 20 ppm or more gluten as a result of cross-contact with gluten-containing grains or other gluten-containing ingredients.
 
Twenty ppm gluten is a concentration level rather than an absolute quantity of gluten in a food. It is equivalent to 20 milligrams of gluten per 1 kilogram (or 1000 grams (g)) of food. [21 CFR 101.91(a)(3)]
 
Please note that the gluten-free final rule published on August 5, 2013. Products labeled on or after August 5, 2014 must comply with the new requirements set forth under 21 CFR 101.91. You may find additional information at:
3.    Your AMAZON coconut water + rooibos tea (infused with acai), AMAZON coconut water + green tea (infused with cupuacu), and AMAZON coconut water + white tea (infused with camucamu) products all declare “Pure Cane Sugar” in their respective ingredient statement. The common or usual name for this ingredient is “sugar” [21 CFR 101.4(b)(20)].
 
4.    Your AMAZON coconut water + rooibos tea (infused with acai), AMAZON coconut water + green tea (infused with cupuacu), and AMAZON coconut water + white tea (infused with camucamu) product labels include the disclaimer “*This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” This disclaimer is only provided for use on dietary supplements in accordance with section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] and 21 CFR 101.93(b). FDA has advised that this statement is not appropriate for use on the labels of conventional foods.
 
5.    Your Cell-nique Super Green Pomegranate product bears “and Lots of Love and Gratitude” as part of the ingredient statement. Since these are not real ingredients added to the product, we suggest that you only declare actual ingredients in an ingredient statement.
 
6.    We also note that your Cell-nique Super Green Pomegranate product bears the claim "NO REFINED SUGAR." However, the intent of your claim may not be clear to consumers and may mislead those who are seeking products that are sugar-free or contain no added sugar. We recommend that you clarify the meaning of your claim
 
We acknowledge your response dated June 3, 2014, to the Form FDA 483, Inspectional Observations, issued by the investigator during the inspection. Our review of this response finds that it pertains to the Form FDA 483, and does not address the labeling violations.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations noted above. Your response should an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation that would assist us in evaluating your corrections. If you cannot complete correction action within fifteen (15) working days, state the reason for the delay and the time in which you will complete the correction.
 
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 non-compliance 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 and assessing and collecting the reinspection 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Ernest F. Bizjak, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Bizjak at 410-779-5715 or ernest.bizjak@fda.hhs.gov.
 
 
Sincerely yours,
/S/                                                           
Evelyn Bonnin
District Director
Baltimore District Office