Inspections, Compliance, Enforcement, and Criminal Investigations

CK Management, Inc. 5/19/15

  

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

Public Health Service
Food and Drug Administration
 Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, Texas 75204-3128
 

May 19, 2015

2015-DAL-WL-18
 

WARNING LETTER

UPS OVERNIGHT MAIL
 

Claude C. Keeland, President
CK Management, Inc.
Pacific East Partners, Inc.
Forbes Pharmaceuticals, LLC
Fruit of the Spirit, LP
Liberty Franklin Pharmaceuticals GP, Inc.
Doctor's Wellness Solutions Global GP, Inc.
4965 Preston Park Blvd., Suite 260
Plano, Texas 75093
 

Dear Mr. Keeland:

From August 19 to 20, 2014, the U.S. Food and Drug Administration (FDA) inspected your warehouse and distribution center located at 7 Sunset Way, Suite 140, Henderson, Nevada, where your products are received, stored, and distributed. During these inspections we collected copies of labels and labeling for your products "Whole5," "Fruit of the Spirit," and "ViaViente." Based on our review of your product labeling, including your firm's websites, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and its implementing regulations.

You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov.

Unapproved New Drug Violations

The FDA reviewed your websites at www.whole5.com, www.viaviente.com, www.fruitspirit.com, and www.fruitofthespirit.net in November of 2014 and March of 2015, and has determined that the websites promote your 'Whole5," "Fruit of the Spirit," and "ViaViente" products for conditions that cause the products to be a drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites 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 claims found on your websites that provide evidence that your products are intended for use as drugs include:

"Fruit of the Spirit" -
From www.fruitspirit.com:
• "Natural anti-inflammatory ... "
• "Anti-Oxidants help protect the human body from the formation of free radicals which cause damage to our cells. Free radicals or "Oxidation" is the product of our bodies' natural metabolic processes. Free radicals can impair our immune system and lead to various chronic diseases related to aging. Extensive scientific evidence links heart disease, stroke, circulation problems, cancer, Alzheimer's, diabetes ... "
• "If you suffer from chronic ... pain, persistent fatigue or insomnia, regularly get sinus, ear, or bladder infections ... concerned about heart disease, diabetes, or any other serious illness, you should be taking Fruit of the Spirit every day."
• "Anti-Oxidants are needed by the body to protect against cell damage. They also may reduce the risk of certain types of cancer and other diseases."
• "[A]n antifungal chemical ... "
• "[H]as also been shown to lower the risk of heart disease, lowering cholesterol levels ... helping protect against Alzheimer's disease ... "

From www.fruitofthespirit.net:
• "Heart healthy ... treat angina, high blood pressure, congestive heart failure and cardiac arrhythmia ... Hawthorn is widely regarded in Europe as a safe and effective treatment for the early stages of heart disease and has been used for a number of ailments including angina, myocarditis, arteriosclerosis, nervous conditions like insomnia, and diarrhea .. .. Hawthorn has primarily been studied in people with congestive heart failure ... found that hawthorn extract (900 mg/day) taken for 2 months was as effective as low doses of captropril (a leading heart medication) in improving symptoms of congestive heart failure ... "
• "Health Benefits of Figs ... protect us from cancers, diabetes, degenerative diseases and infections ... research studies suggest that chlorogenic acid in these berries help lower blood sugar levels and control blood-glucose levels in type-11 diabetes mellitus (Adult onset) condition ... "
• "Pomegranate ... Healing benefits: ... Reduces cholesterol. .. Inhibits viral infections ... Cancer, especially prostrate (sic) and breast..."
• "Asthma, diabetes, cancer, cataracts, Parkinson's, heart disease are but a few of the disease conditions associated with oxidative stress ... "
• [T]hese compounds fight Crohn's disease, inhibit HIV ... and fight herpes. Preliminary studies have also shown that aronia may prove helpful in slowing the growth of glioblastoma-a form of fatal brain cancer ... "
• "Inflammation is considered to be an important risk factor for cardiovascular disease as well as diabetes and other conditions including strokes ... reduce the risk of high blood pressure, obesity, diabetes, arthritis, and other degenerative chronic disease ... Additional fruits and vegetables such as the nutritional equivalent of 5 servings found in one ounce of Fruit of the Spirit are known to reduce the risk of not only heart disease but also cancer ... "
• "7 Dangers of an Imbalanced pH ... Cancer ... Heart Disease ... Diabetes ... Osteoporosis & Osteoarthritis ... Dangerous Cholesterol Levels ... Acid pH is so corrosively destructive that it is considered a seedbed for most, if not all, degenerative diseases including heart disease, diabetes, obesity, premature aging and osteoporosis .... "
• ''[nhat Arthritis in the knee or shoulder, it's not bothering me anymore ... it has a number of substances within the Fruit of the Spirit. One is Myrrh ... Frankincense, all extremely anti-inflammatory ... "
• "Frankincense & Myrrh are both known to be the strongest natural antiinflammatory herbs for treating depression and claustrophobia ... Aronia berry also known as the Black Chokeberry ... been known to help people with heart conditions ... Resveratrol may counter type 2 diabetes and insulin resistance ... lowers the risk of heart disease and lowers cholesterol levels ... helping to protect against Alzheimer's disease ... "
• "[B]enefits which include: ... Decrease in heart disease risk ... Support for healthy cholesterol levels ... Shows promise in decreasing the growth of some cancers ... Protection against Alzheimer's disease ... "

"ViaViente"-
From www. viaviente.com:
• "[W]hole fruit puree juice blend that is rich in anti-oxidants ... Anti-Oxidants help protect the human body ... evidence links heart disease, stroke, circulation problems, cancer, Alzheimer's, diabetes ... "
• "[T]hat inflammation is involved in diseases like heart disease, Alzheimer's, and various Cancers ... "
• On http://viavientemedia.com, accessible via a direct link embedded in your www.viaviente.com website, next to a heart symbol: "[D]iagnosed with pulmonary hypertension, which is a type of high blood pressure that affects the arteries in the lungs ... Lung Transplant No Longer Needed ... "
• On http://viavientemedia.com, accessible via a direct link embedded in your www.viaviente.com website, above or next to a heart symbol: "Miracle Heart Cure ... Natural Heart Remedy ... When Diane Vivian developed heart problems, she thought traditional medicine was the only answer ... she discovered an amazing all-natural beverage that got her heart beating on the right track again. After an exam and EKG, the doctor determined Diane had atrial fibrillation a disorder affecting 2.2 million Americans in which the upper two chambers of the heart beat irregularly. By having it, Diane was at risk of developing blood clots that could lead to a stroke ... "

From www.whole5.com:
• "Please describe Whole5 ... A. An energizing whole fruit puree juice that is rich in anti-oxidants ... Anti-oxidants help protect the human body... lead to various chronic diseases related to aging. Extensive scientific evidence links heart disease, stroke, circulation problems, cancer, Alzheimer's, diabetes ... "
• "[U]nderstanding why and how people develop heart disease, stroke, cancer, diabetes, rheumatoid arthritis, Alzheimer's disease and more ... Chronic inflammation causes heart attacks, stroke - and even cancer ... Though cancer, diabetes, heart disease, stroke, Alzheimer's and even depression appear to be very different, researchers are finding that these disease conditions have one common denominator - lnflammation ... Anti-Oxidants extinguish the fire ofinflammation ... Whole5 was created to ensure that you consume the Anti-Oxidant equivalent of 5-10 servings of Whole Fruits and Vegetables every day.... "

Your website www.whole5.com also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your "Whole5" product for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

• "[M]y arthritis pain and inflammation improved. I've depended on strong muscle relaxers and anti-inflammatories to help me. Now that I am drinking Whole5®, I don't need those meds anymore to feel good ... "
• "[F]or my high blood pressure ... "
• "[H]as helped me very much with my diabetes and also my aches and pains ... "
• "[A]sthma attacks ... especiallythose with asthma or allergies ... "

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 marketed in the U.S. without prior approval from 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.

Furthermore, your "Whole5," "Fruit of the Spirit," and "ViaViente" products are 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 these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of misbranded drugs into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].

Misbranding Violations

Even if your "Whole5," "Fruit of the Spirit," and "ViaViente" products were not unapproved new drugs, they would still be misbranded foods within the meaning of section 403 of the Act (21 U.S.C. § 343).

The FDA reviewed the website at http://viavientemedia.com, accessible via a direct link embedded in your www.viaviente.com website titled ''Via Media," in November of 2014 and March of 2015, and has detennined that the http://viavientemedia.com website misbrands your "ViaViente" product within the meaning of section 403 of the Act (21 U.S.C. § 343) as follows:

1. Your "Whole5," "Fruit of the Spirit," and "ViaViente" products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)) because their labeling bears nutrient content claims, but the products do not meet the requirements to make the 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 food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(l)(A) of the Act. Specifically,

a. Your "ViaViente" and "Fruit of the Spirit" labeling contain the nutrient content claim "Low in calories." In accordance with 21 CFR 101.60(b)(2)(i)(A), this claim may be made on the label or in the labeling of foods that contain 40 calories or less per Reference Amount Customarily Consumed (RACC). However, your "ViaViente" and "Fruit of the Spirit" products do not qualify for this claim because, according to the labels' Nutrition Facts panels, "ViaViente" contains 200 calories per 8 oz RACC for beverages, and "Fruit of the Spirit" contains 160 calories per 8 oz RACC.

b. Your "Whole5" (32 oz and 8 oz sizes), "Fruit of the Spirit," and "ViaViente" product labels contain the claim "No Sugar Added." In accordance with 21 CFR 101.60(c)(2)(v), if a product is not a low calorie food, a "no added sugar" claim may only be made if the product label bears a statement that the food is not low calorie, and that directs consumers' attention to the Nutrition Facts panel for further infonnation on sugar and calorie content. As discussed above, these products are not low calorie foods. However, their product labels do not bear statements that they are not low calorie foods in conjunction with the no added sugars claims.

c. Your "ViaViente" and "Fruit of the Spirit" product labels contain the nutrient content claim "Low in ... Carbs." FDA has not defined nutrient content claims for carbohydrates; therefore, the use of this claim misbrands your product under section 403(r)(1)(A) of the Act.

d. The labeling for your "Fruit of the Spirit" product, located on the website, www.fruitofthespirit.net, contains the nutrient content claim "Low sugar." While FDA has defined some nutrient content claims for sugar in 21 CFR 101.60(c), FDA has not defined "Low sugar"; therefore, the use of this claim misbrands your product under section 403(r)(1)(A) of the Act. The claim "lower sugar" may be used on the label or labeling of foods provided that it meets the requirements of 21 CFR 101.60(c)(5). 21 CFR 101.60(c)(5) requires, in part, that the claim declares the identity of an appropriate reference food and the percent (or fraction) that the sugar differs between the two foods. The claim on your "Fruit of the Spirit" product labeling does not meet these requirements.

e. Your "Fruit of the Sprit" label, located on the website www.fruitofthespirit.net, contains the nutrient content claim, "contain good levels of B-complex group of vitamins such as niacin, pyridoxine, folates and pantothenic acid ... " In accordance with 21 CFR 101.54(c), the terms "good source" or "contains" may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 10 to 19 percent of the Reference Daily Intake (RDI) or Daily value (DV) per reference amount customarily consumed (RACC). Because your "Fruit of the Spirit" product labeling fails to declare nutrients levels for any B-complex vitamins except for Vitamin B12 (listed as 0%), it is not clear whether your "Fruit of the Spirit" product has the required minimum percentages of the RDI or DV per RACC required under 21 CFR 101.54(c) for the use of the defined terms "good source." and "contains." Under 21 CFR 101.13(n), nutrition labeling in accordance with 101.9 must be provided for any food for which a nutrient content claim is made.

Under 21 CFR 101.9(c)(8)(ii), vitamins and minerals listed in 21 CFR 101.9(c)(8)(iv) must be declared as part of the nutrition labeling for a product when a claim is made about them. However, the levels of niacin, folate, and pantothenic acid are not declared as part of the nutrition labeling for your "Fruit of the Spirit" product, as required under 21 CFR 101.9(c)(8)(ii). Therefore, your "Fruit of the Spirit" product is misbranded under section 403(r)(1)(A) of the Act and section 403(q) of the Act [21 U.S.C. § 343(q)], because it does not provide information under 21 CFR 101.9(c)(8)(ii) on the levels of referenced vitamins and minerals for which a claim is made, as required under21 CFR 101.13(n).

f. Your "Whole5," "Fruit of the Spirit," and "ViaViente" product labels contain claims that they are "high" or "rich" in anti-oxidants but do not list the nutrients that are the subject of the claim, or contain a link with a symbol that refers to the same symbol that appears elsewhere on the same panel followed by the name of the nutrients that are the subject of the claim. In accordance with 21 CFR 101.54(g), a claim that characterizes the level of anti-oxidant nutrients may be made only if a Recommended Daily Intake (RDI) has been established for each of the nutrients that are subject of the claim; those nutrients have recognized anti-oxidant activity; the level of each nutrient that is the subject of the claim is sufficient to quality for the claim (e.g., for "high" or "rich" claims, the products must contain 20% or more of the RDI for the nutrients); and the claim includes the names of the nutrients that are the subject of the claim, or is linked by a symbol that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name(s) of the nutrients with recognized anti-oxidant activity.

Your "Whole5," "Fruit of the Spirit," and "ViaViente" product labels also contain implied nutrient content claims about anti-oxidants. All three product labels contain similar statements regarding the anti-oxidant equivalence of 1 oz of the product to 5 servings of fruits and vegetables. The "Whole5" products labels declare "1 oz = 5 servings Fruits & Vegetables Anti-Oxidant* Equivalent" linked by asterisk to the statement "In addition to the Anti-Oxidant Power of our Fruits & Vegetables, contains Anti-Oxidant Vitamins C and E." The "Fruit of the Spirit" product label states "1 oz equals 5 Servings Of Fruits & Vegetables*" that is linked by asterisk to "In addition to the Anti-Oxidant Power of our Fruits & Vegetables, contains Anti-Oxidant Vitamins C and E." The "ViaViente" product label declares "1 oz Equals 5 Servings of Fruits & Vegetables*" linked to the statement "* 1 oz. Equals the Anti-Oxidant Nutrient Equivalent of 5 Servings of Fruits & Vegetables." As noted above, claims that characterize the level of anti-oxidant nutrients must meet the requirements of 21 CFR 101.54(g). Because none of these claims state the names of the anti-oxidant nutrients in the products, other than vitamins C and E, these claims do not meet the requirements of 21 CFR 101.54(g). Further, we note that such implied claims must also meet the requirements in 21 CFR 101.65(c)(2), which requires, in part, that the reference food is enough to qualify that food as a "good source" (21 CFR 101.54(c)) of the subject nutrient.

2. Your "Whole5," "Fruit of the Spirit," and "ViaViente" products are misbranded with the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because:

a. They are beverages that contain juice, but their labels fail to declare a statement of the total percentage of juice in the products. In accordance with 21 CFR 101.30(b)(1), if a beverage contains fruit or vegetable juice, the percentage of juice shall be declared by the words, "Contains _ percent (or %) juice," or similar phrase, with the blank filled in with the percentage expressed as a whole number of the juice.

b. The ingredient statement of your "ViaViente" /abel lists ingredients such as "Mineral Water "from a Rainforest in the Andes Mountains" and "Whole Grape Puree containing Resveratrol," and the ingredient statement of your Fruit of the Spirit label lists "Dead Sea Mineral Complex." Ingredients required to be declared on the label or labeling of food must be listed by their common or usual name and without intervening material [21 CFR 101.4(a)(1) and 101.2(e)]. "Dead Sea Mineral Complex" is not a common or usual name of an ingredient, and statements such as ''from a Rainforest in the Andes Mountains" and "containing Resveratrol" are considered to be intervening material because they are not part of the common or usual name of the ingredient. Further, if the "Dead Sea Mineral Complex consists of sub-ingredients, those ingredients must also be declared in accordance with 21 CFR 101.4(b)(2).

c. The "Fruit of the Spirit" ingredient statement does not appear to be in agreement with the production record listing the actual ingredients used as required by 21 CFR 101.4. Your firm's legal counsel provided a 483 response to FDA dated 4/28/2014. Attached to this document were production records for "Fruit of the Spirit." According to this information, the product is made with water, "Fruit of the Spirit Powder Blend," apple juice concentrate, grape juice concentrate, citric acid, and antifoaming agent. The apple juice concentrate, grape juice concentrate, and citric acid are not declared on the labeling. There is no indication that any whole fruit purees are used to make this product despite the labeling which lists 12 whole fruit purees. Instead, the product is made with powders and extracts of the fruits listed on the labeling, magnesium chloride, potassium chloride, and sodium chloride. These are not declared on the product labeling.

3. Your "Fruit of the Spirit' and 'Whole5" products are misbranded within the meaning of 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that they are labeled with the following unauthorized health claims:

a. The claims "Diets Rich in Fruits & Vegetables have been shown to Lower Blood Pressure & Improve other Cardiovascular Disease Risk Factors ... Journal of the American Heart Association" and "Both the American Cancer Society & American Heart Association encourage people to consume 5 Servings of FRUITS & VEGETABLES EVERY DAY to Reduce Their Risk of Disease!" are located on your www.fruitspirit.com website and/or contained within your tri-fold brochure available for download from the same. Additionally, the claim "Both the American Heart Association and the American Cancer Society state that increasing our consumption of whole fruits and vegetables can significantly reduce the risk of heart disease, stroke, diabetes, high blood pressure, high cholesterol and cancer'' is located on your wholeS.com website. These claims misbrand your products because they have not been authorized either by regulation (see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)-(B)]) or under authority of the health claim notification provisions of the Act (see section 343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]). Although there are authorized health claims regarding fruits and vegetables and some cancers and coronary heart disease under 21 CFR 101.76, 101.77, and 101.78, none of the claims above meet the requirements to make these authorized claims.

FDA's authorized health claim regarding fruits and vegetables and a reduced risk of cancer under 21 CFR 101.78 requires, in part, that the claim states that diets low in fat and high in fruits and vegetables "may" or "might" reduce the risk of some cancers. Further, in specifying the disease, the claim must the following terms: "some types of cancer," or "some cancers." Additionally, the claim must characterize fruits and vegetables as foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber; characterize the food bearing the claim as containing one or more of the following, for which the food is a good source under 21 CFR 101.54: dietary fiber, vitamin A, or vitamin C; and indicate that development of cancer depends on many factors. However, the claim on the labeling for your "Whole5" product relating, in part, to fruits and vegetables and cancer does not contain these required elements under 21 CFR 101.78(c)(2).

FDA's authorized a health claim regarding fiber-containing grain products, fruits, and vegetables and a reduced risk of cancer under 21 CFR 101.76 requires, in part, that the claim state that diets low in fat and high in fiber containing grain products, fruits, and vegetables "may" or "might" reduce the risk of some cancers; in specifying the disease, the claim uses the terms: "some types of cancer," or "some cancers"; and that the claim indicates that development of cancer depends on many factors. However, the claim on the labeling for your "Whole5" product relating, in part, to fruits and vegetables and cancer does not contain these required elements under 21 CFR 101.76(c)(2)(i).

FDA's authorized health claim regarding fruits, vegetables and grain products that contain fiber and a reduced risk of heart disease under 21 CFR 101.77 requires, in part, that the claim state that diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber "may " or "might" reduce the risk of heart disease; the claim uses the terms "heart disease" or "coronary heart disease" in specifying the disease; in specifying the fat component the claim uses the terms "saturated fat" and "cholesterol"; and the claim indicates that development of heart disease depends on many factors. However, the labeling claims regarding fruits and vegetables and heart disease for your 'Whole5" and "Fruit of the Spirit" do not contain these required elements under 21 CFR 101.77(c)(2)(i).

b. "Resveratrol has also been shown to lower the risk of heart disease ... " is located on your www.fruitspirit.com webpage entitled "The Science Behind Fruit of the Spirit". There are no authorized health claims for resveratrol, which is an ingredient in "Fruit of the Spirit."

4. The "ViaViente" product in misbranded within the meaning of section 403(i)(1) [21 U.S.C. 343(i)(1)] in that the product label does not contain a statement of identity as required by 21 CFR 101.3.

5. Your "Fruit of the Spirit" product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because the labeling on your website, www.fruitspirit.com, states the product is "FDA Approved." This statement is false and misleading because FDA has not approved your food product, nor does FDA generally approve food products. Further, your "Fruit of the Spirit," "ViaViente" and "Whole5" products are misbranded within the meaning of section 403(a)(1) of the Act because the labeling states that "1 OZ. EQUALS 5 SERVINGS OF FRUITS AND VEGETABLES" ("Fruit of the Spirit" and "ViaViente") and "1 oz = 5 SERVINGS FRUITS & VEGETABLES ANTIOXIDANT EQUIVALENT" ("Whole5"). Both of these statements are in regard to the anti-oxidant levels of the finished products. Brunswick Labs oxygen radical absorbance capacity (ORAC) reference values-the source of your claim according to your product labeling-indicate that several fruits (e.g., strawberries) contain higher levels of ORAC values per serving than one ounce of your products. Since your claims do not specify which fruits and vegetables are used as the basis for your claims, the claims are misleading because they appear to apply to all fruits and vegetables.

6. Your "Whole5," "Fruit of the Spirit," and "ViaViente" products are misbranded with the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that:

a. The Nutrition Facts panels for the Fruit of the Spirit and Whole5 products identify the serving size as "1 oz" which is not in compliance with 21 CFR 101.9(b) and 21 CFR 101.12(b ). The products are represented to be beverages and the RACC for a beverage is 240 ml or 8 ounces, per 21 CFR 101.12(b), Table 2.

b. The ViaViente product labeling declares two serving size declarations in the nutrition information. It declares a "Suggested Serving Size" and "Standard Serving Size." These designations are not pennitted under 21 CFR 101.9. Only the heading "Serving Size" and approved abbreviations are permitted. Further the labeling declares "suggested 33" as the number of servings per container which is not pennitted under 21 CFR 101.9.

The above list is not intended to be an all-inclusive list of deficiencies with your products, labels, and labeling. It is your responsibility to assure that your establishments are in compliance with all requirements of the Act and federal regulations. You should take prompt measures to correct all violations described in this letter. Failure to take appropriate corrective action may subject your firm and products to further actions, such as injunction or seizure.

We also have the following comments regarding your labels:

• Your "Whole5," "Fruit of the Spirit," and "ViaViente" product labels fail to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5(d).

• All of the product labels except for the 1 oz Go Pak individual units contain intervening material [21 CFR 101.2(e)]. For example the "ViaViente" labeling contains claims between the nutrition information and name and place of business. The "Whole5" and "Fruit of the Spirit" product labels contain UPC codes and use by information between nutrition information and the name and place of business declaration.

• We have concerns surrounding the use and reliability of ORAC assays, which you say you use to support anti-oxidant claims on the labeling of your "Fruit of the Spirit," "ViaViente," and "Whole5" products. Specifically, there are various versions of ORAC assays and other measures of anti-oxidant capacity that use different substrates and different radical or anti-oxidant sources. Therefore, such assays generate distinct values that cannot be compared directly. In addition, in 2012, the United States Department of Agriculture (USDA)'s Nutrient Data Laboratory (NDL) removed the USDA ORAC Database for Selected Foods from the NDL website. Among the reasons cited were mounting evidence that the values indicating anti-oxidant capacity (such as ORAC) have no relevance to the effects of specific bioactive compounds. For these reasons, the use of claims about anti-oxidants that you state are supported by ORAC values may be false or misleading.

You should notify this office in writing within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent their recurrence. In your response, include documentation of your corrective actions or steps towards long tenn corrective actions. If you cannot complete all corrective actions before you respond, you should explain the reason for your delay and state when you will correct the remaining deficiencies.

Your written response should be sent to Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Thao Ta at (214) 253-5217.

Sincerely,
/S/
Reynaldo R. Rodriguez, Jr.
Dallas District Director

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