| | |
 Department of Health and Human Services
| Public Health Service
Food and Drug Administration |
| | 555 Winderley Pl., Ste. 200
Maitland, FL 32751
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CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-10-24
July 8, 2010
Mr. Thomas R. Fuhnnan
Florida Bottling, Inc
1035 NW 21st Terrace
Miami, FL 33127
Dear Mr. Fuhnnan:
The U.S. Food and Drug Administration (FDA) inspected your facility located at 1035 NW 21st Terrace, Miami, FL 33127 and established that your firm manufactures and distributes beverage products. The FDA also reviewed your website at www.lakewoodjuices.com in June 2010 and have determined that this site constitutes labeling under section 201(m) of the Federal Food, Drug and Cosmetic Act (the Act). The FDA has determined that your Fresh Pressed Blueberry Blend, Pure Aloe, Pure Pomegranate (organic), and Tart Cherry juice products are in violation of the Act. You may find the Act and the Code of Federal Regulations for Food Labeling at FDA's home page at www.fda.gov.
Unapproved New Drug
Your product labels and your websites at www.lakewoodjuices.com and www.floridabottling.com, promote your juice beverage products for conditions that cause them to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. 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. The marketing of these products with these claims violates the Act. Examples of some of the disease claims on your product labels and observed on your website include:
Fresh Pressed Blueberry Blend label and webpage:
• "[R]educes infections"
Pure Pomegranate (organic) label and webpage:
• "Powerful antioxidant with anti-adhesion effects to fight artherosclerosis [sic]"
• "Ellagic acid to help inhibit the growth of cancer cells"
Pure Aloe:
• Label:
o "Reduce Swelling in Joints"
o "Healing Bums and Wounds"
o "Effective Skin Emollient with Antibacterial, Antifungal and Antiviral Properties"
• Website:
o "Drinking aloe vera juice can aid in the healing of ... ulcers ...."
Tart Cherry label and webpage:
• "Reduce the Pain of Arthritis, Gout ..."
Your products are not generally recognized as safe and effective for the above referenced, uses; 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 marketed in the US. without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. 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. In addition, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; hence, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended use. Therefore, your products are also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
Unauthorized Health Claims
Even if your product labeling did not include claims that cause your products to be drugs, your Fresh Pressed Blueberry Blend and Tart Cherry juice beverage products are misbranded foods under section 403(r)(1)(B) of the Act [21 US.C. § 343(r)(1)(B)] because the labeling bears unauthorized health claims. Your product labels and your website, www.lakewoodjuices.com. were reviewed and were found to contain a number of unauthorized health claims, including:
Fresh Pressed Blueberry Blend label and webpage:
• "Heart Healthy"
• "Reduction of risk factors related to Cancer, Heart Disease, Stroke & Alzheimer's"
Tart Cherry label and webpage:
• "Heart Healthy"
• "Reduce the Risk Factors Related to Heart Disease"
The claim "heart healthy" is an implied health claim that characterizes that relationship between these juice products and reduced risk of heart disease. All of the above claims are unauthorized health claims because there is no health claim authorized by regulation or the Act that provides for health claims that characterize the relationship between these juice products and heart disease, cancer, stroke, or Alzheimer's disease.
Unauthorized Nutrient Content Claims
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], 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 promulgated by the Secretary. (and, by delegation, FDA) authorizing the use of such a claim. The use of a term not defined by regulation in food labeling to characterize the level of a nutrient misbrands a product under section 403(r)(1)(A) of the Act.
Nutrient content claims using the terms "high," "rich in," or "excellent source of" may be used on the label and in the labeling of foods provided that the food contains 20 percent or more of the reference daily intake (RDI) or the daily reference value (DRV) per reference amount customarily consumed (RACC) [21 CFR 101.54(b)(1)]. Therefore, claims made on the label and website for your Pure Aloe juice beverage product are unauthorized nutrient content claims because, according to the label, the product contains less than the required 20 percent RDI or DRV per RACC of the nutrient for which the claim is made. Specifically, your Pure Aloe product label and webpage bear the claim "Excellent sources of ... Fiber ...." The Nutrition Facts panel declares that a 4 fl oz serving of the product contains 8% of the Daily Value for fiber. The RACC for fruit juices is 240 mL, or 8 fl oz; therefore, this product contains only 16% of the Daily Value for fiber per RACC.
Nutrient content claims using the term "antioxidant" must also comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, an RDI must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(1)], and these nutrients must have recognized antioxidant activity [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) [21 CFR 101.54(g)(3)]. 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 [21 CFR 101.54(g)(4)). The use of a nutrient content claim that uses the term "antioxidant" but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under 403(r)(1)(A) of the Act. Therefore, the claims "Super Anti-Oxidant" and "Tremendous Source of Anti-Oxidants" for your Pure Aloe product are unauthorized nutrient content claims because the source of the antioxidant is not identified with use of the term as required in 21 CFR 101.54(g)(4).
Your Tart Cherry product 'label bears the unauthorized nutrient content claims "Tremendous Source of Anti-Oxidants" and "Organic Grape Seed: Tremendous Anti-Oxidant Values." The terms "tremendous source" and "tremendous" characterize the level of antioxidant nutrients in the product and, therefore, these claims are nutrient content claims (see section 403(r)(1) of the Act and 21 CFR 101.13(b)). Even if we determined that the terms "tremendous source" and "tremendous" could be considered synonyms for a term defined by regulation (e.g., "good source" or "high"), nutrient content claims that use the term "antioxidant" must meet the requirements of 21 CFR 101.54(g). The above claims do not include the nutrients that are the subject of the claims or use a symbol to link the term "antioxidant" to those nutrients, as required by 21 CFR 101.54(g)(4). Thus, these unauthorized nutrient content claims cause your product to be misbranded under section 403(r)(2)(A)(i) of the Act.
Your Tart Cherry product label also bears the unauthorized nutrient content claims "Enriched with: Organic Rose Hips: Rich in Bio-Flavonoids for free radical protection" and "Enriched with ... Organic Grape Seed," and your Pure Pomegranate (organic) label bears the unauthorized nutrient content claim "Rich in polyphenols & flavonoids to combat free radical damage." The terms "enriched" and "rich in" are defined by regulation and may be used to describe the level of certain substances for which an RDI or Daily Reference Value (DRV) has been established (21 CFR 101.54(b) and (e). Therefore, because rose hips, grape seed, polyphenols, and flavonoids do not have an established RDI or DRV, these claims are unauthorized.
Other Food Labeling Violations
Your Fresh Pressed Blueberry Blend, Pure Pomegranate (organic), Pure Aloe, and Tart Cherry juice beverage products are further misbranded within the meaning of Section 403(q)(1) of the Act [21 U.S.C. 343(q)(1)] because the nutrition facts information is not in the proper format as defined in 21 CFR 101.9. Specifically, the Pure Aloe, Pure Pomegranate (organic), Tart Cherry, and Fresh Pressed Blueberry Blend product labels fail to properly declare the serving size as specified by 21 CFR 101.9(b) and 101.12(b). The serving size for a fruit juice product is based on the RACC, which is 240 mL, or 8 fl oz. However, the Pure Pomegranate (organic), Pure Aloe, and Fresh Pressed Blueberry product labels declare a serving size of 4 fl oz, and the Tart Cherry label declares a serving size of 6 fl oz.
Your Organic Pure Aloe juice beverage product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the percentage of fruit juice is declared in the incorrect format. Specifically, 21 CFR 101.30(e)(1) requires that the percent juice statement appear near the top of the information panel with no other printed label information appearing above the statement except the brand name, product name, logo, or universal product code. Your product label includes the statement "Contains Pure Aloe Vera Fortified & Enriched" above your percent juice statement.
The above violations are not meant to be an all-encompassing list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your websites, product labels, and other labeling or promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. You should take prompt action to correct these violations and prevent their future recurrence. Failure to correct these violations may result in regulatory actions without further notice, such as seizure and/or injunction [21 U.S.C. §§ 332 and 334].
We also have the following additional comments regarding your labels:
• Your Fresh Pressed Blueberry Blend product label does not comply with the requirements for declaring the statement of identity. Specifically, in a diluted multiple-juice blend or blend of single-strength juices where one or more, but not all, of the juices are named on the label other than in the ingredient statement, and where the named juice is not the predominant juice, the common or usual name for the product shall either indicate that the named juice is present as a flavor or flavoring (21 CFR 102.33(d)(1)) or include the amount of the named juice, declared in a 5-percent range (21 CFR 102.33(d)(2)). The named juice in this product is blueberry juice, and the ingredient statement indicates that blueberry juice is not the predominant juice because it is not listed first in the ingredient statement. However, the statement of identity does not indicate that blueberry juice is present as a flavor or flavoring (e.g., "Apple and Blueberry Juice Beverage") or include the amount of blueberry juice.
• Your Fresh Pressed Blueberry Blend, Pure Pomegranate (organic), Pure Aloe, and Tart Cherry product labels declare a percent Daily Value (% DV) for trans fat on the "Nutrition Facts" panel. A % DV for trans fat has not been established; consequently, it cannot be declared on the label.
• The Organic Pure Aloe product label fails to bear a common or usual name that accurately describes the basic nature of the product or its characterizing properties or ingredients [21 CFR 102.5]. Since the ingredient statement contains "organic lemon juice" and "organic lime juice," it appears to be a juice in a blend of two other fruit juices, and the common or usual name should signify that the product is a juice blend.
• The information panel of your Organic Tart Cherry product label bears a logo that separates the Nutrition Facts panel from the name and place of business of the firm. Under 21 CFR 101.2(e), all information required to appear on the information panel must appear in one place without other intervening material.
• Your Fresh Pressed Blueberry Blend label expresses the number calories from fat as 2. Under 21 CFR 101.9(c)(1)(ii), the number of calories from fat must be expressed to the nearest 5-calorie increment, but amounts less than 5 calories may be expressed as zero. Except as provided under 21 CFR 101.9(f), if calories from fat are not required and are not declared, the statement "Not a significant source of calories from fat" must be placed at the bottom of the table of nutrient values in the same type size [21 CFR 101.9(c)(1)(ii)].
• According to their labels, your Fresh Pressed Blueberry Blend, Tart Cherry, and Pure Pomegranate (organic) products contain 1, 4, and 3 mg of sodium, respectively, per serving. Under 21 CFR 101.9(c)(4), the number of milligrams of sodium in a serving must be expressed as zero when the serving contains less than 5 mg of sodium.
• According to their labels, your Fresh Pressed Blueberry Blend and Pure Pomegranate (organic) products contain 0.5 g of protein per serving. The number of grams of protein in a serving must be expressed to the nearest gram; however, if a serving contains less than 1 gram, the statement "Contains less than 1 gram" or "less than 1 gram" may be used as an alternative [21 CFR 101.9(c)(7)].
• Your Pure Pomegranate (organic) product declares that each serving contains 0.5 grams of dietary fiber. Under 21 101.9(c)(6)(i), the number of grams of total dietary fiber per serving must be expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required or, alternatively, the statement "Contains less than 1 gram" or "less than 1 gram" may be used [21 CFR 101.9(c)(6)(i)].
• Your Pure Aloe label does not express total calories to the nearest 5-calorie increment up to and including 50 calories, as required by 21 CFR 101.9(c)(1)]. Your product declares Total Calories as 4.
• Your Fresh Pressed Blueberry Blend, Pure Pomegranate (organic), and Tart Cherry juice products do not express all of the percentages for vitamins and minerals to the nearest 2-percent increment up to and including the 10-percent level, as required by 21 CFR 101.9(c)(8)(iii).
• Your Pure Aloe juice label does not list Vitamin A, calcium, and iron as required by 21 CFR 101.9(c)(8)(ii).
Please respond to this Warning Letter within fifteen (15) days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete the corrective actions within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to the Food and Drug Administration, Attention: Carla A. Norris, Compliance Officer, Maitland District Office, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Carla Norris at (407) 475-4730.
Sincerely,
/S/
Emma R. Singleton
Florida District Director
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