Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm519400.htm
Timestamp: 2019-04-26 04:36:19+00:00

Document:
The U.S. Food and Drug Administration (FDA) conducted an inspection at your firm, Salud Natural Entrepreneurs, Inc., located, at the time of the inspection, at 2400 23rd Street in Zion, Illinois, from May 26, 2015, through July 6, 2015. Our inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal, Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
In addition, FDA reviewed your product labels and your website at the Internet address www.nopalinausa.com in February 2016. Based on our review, we have concluded that certain products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. 343, 355(a), and/or 352(f)(1)]. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
The FDA reviewed your products labels and your website at www.nopalinausa.com in February 2016, from which website you take orders for your products Aloe Vera Juice, Urinary System Tea, Nopalina Flax Seed Plus Fiber Powder and Capsules, Urcran Cranberry, Aloe Vera With Nopal Juice, Aloe Vera With Nopal And Grape Juice, Aloe Vera Gel, Cardio Support, Fat Burner, Liver Support, Prostate Support, Triple Potency, Uro-Max Formula, Arthritis Formula, Diabetes Formula, Sinusitis Bronchitis Capsules, Urinary System Tea, Respiratory System Tea, Obesy-Tea, Blood Purifier Tea, Diabetes Kit, and Overweight and Cholesterol Kit. The claims on your product labels and your website establish that these products are drugs under section 201(g)(1)(B) of 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.
Product name implies product is intended for use in the treatment of arthritis.
Product name implies product is intended for use in the treatment of diabetes.
Product name implies product is intended for the treatment of sinusitis and bronchitis.
Product name is an implied drug claim.
“Cholesterol Kit” is an implied drug claim.
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 sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Your Aloe Vera Juice, Nopalina Flax Seed Plus Fiber (in both powder and capsule form), Aloe Vera with Nopal Juice, Aloe Vera With Nopal and Grape Juice, Aloe Vera Gel, Cardio Support, Liver Support, Prostate Support, Triple Potency, Uro-Max Formula, Arthritis Formula, Diabetes Formula, Sinusitis Bronchitis Capsules, Urinary System Tea, Obesy-Tea, Blood Purifier Tea, Diabetes Kit, and Overweight and Cholesterol Kit products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Aloe Vera Juice, Nopalina Flax Seed Plus Fiber (in both powder and capsule form), Aloe Vera with Nopal Juice, Aloe Vera With Nopal and Grape Juice, Aloe Vera Gel, Cardio Support, Liver Support, Prostate Support, Triple Potency, Uro-Max Formula, Arthritis Formula, Diabetes Formula, Sinusitis Bronchitis Capsules, Urinary System Tea, Obesy-Tea, Blood Purifier Tea, Diabetes Kit, and Overweight and Cholesterol Kit products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction of or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Additionally, even if certain of your dietary supplement products did not contain disease claims in their labeling that cause them to be drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
b. Specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, as required by 21 CFR 111.70(e).
Once you have established the above specifications, you must verify that the specifications are met in accordance with 21 CFR 111.73, and you must make and keep records relating to the specifications you have established, in accordance with 21 CFR 111.95(b).
We acknowledge your response, dated January 27, 2016. We are unable to determine the sufficiency of your response because the specifications documented in your response do not meet the criteria required by 21 CFR 111.70. For example, the component specifications you provided for senna leaves will not determine the required component specifications for identity. The (b)(4) are inadequate identity specifications because they lack the specificity to distinguish other powders of similar characteristics.
2. You failed to implement quality control operation procedures in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65. Specifically, you have not established or implemented quality control procedures for activities such as ingredient scale calibration, mix time control, and temperature control in juice processing.
3. You failed to prepare a written master manufacturing record (MMR) for each unique formulation of dietary supplement you manufacture and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). For each dietary supplement product you manufacture, including your aloe-based dietary supplement juice products, you must establish complete MMR’s that include the information specified under 21 CFR 111.210. You do not have MMR’s for your aloe-based dietary supplements.
We acknowledge your response, dated January 27, 2016, includes a blank manufacturing record template. However, we are unable to fully evaluate a blank template to determine if your use of the template will satisfy the requirements under 21 CFR 111.205 and 21 CFR 111.210.
4. You failed to prepare a batch production record (BPR) every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, you do not have BPRs for the production of your aloe-based products. BPRs must include complete information relating to the production and control of each batch in accordance with 21 CFR 111.255(b) and 21 CFR 111.260.
We acknowledge your response, dated January 27, 2016. However, we are unable to evaluate the sufficiency of your response because you failed to provide batch production records.
5. Your firm used equipment that was not maintained to protect components and dietary supplements from being contaminated by any source, as required by 21 CFR 111.27(a)(3)(v). Specifically, your employees used a (b)(4) to move your finished Nopalina Flax Seed Plus Fiber powder from a (b)(4). The distal end of the (b)(4) was observed to be constructed with (b)(4) which was holding the (b)(4). The (b)(4) was observed to be loose and in a state of disrepair and directly over the finished product. An adjacent packaging line was observed to be in a similar state of disrepair.
We acknowledge your response, dated January 27, 2016. However, we are unable to evaluate the sufficiency of your response. We understand from your response that you employed (b)(4) to assist in strengthening the cleaning and sanitization program, and you included with your response a copy of the (b)(4) report, dated 1/19/16, as well as cleaning procedures entitled, “(b)(4)” Procedure 1001.01.1, (b)(4). The documentation you provided, however, failed to provide evidence to show that you are maintaining the equipment to protect components and dietary supplements from being contaminated by any source.
Your Parasitos, Aloe Vera Juice, Diabet-Care and Nopalina Flax Seed Plus Fiber product labels fail to declare all parts of the statement of identity, the net quantity of contents statement, and the Supplement Facts in both English and Spanish.
Your Nopalina Flax Seed Plus Fiber product label fails to declare the FDA disclaimer statement under section 403(r)(6)(C) of the Act in both English and Spanish.
Your Parasitos product label fails to include the part of the plant from which “horsetail” and “buckthorn” are derived.
Your Aloe Vera Juice product label fails to include the part of the plant from which “aloe vera” is derived.
Your Nopalina Flax Seed Plus Fiber product label fails to include the part of the plant from which “edible cactus” is derived.
Your Buzz Recovery Detox Juice product label fails to include the part of the plant from which carqueja, poleo mint, thyme, chamomile, vira vira canchalagua, and blessed thistle are derived.
Your Diabet-Care product fails to include the part of the plant from which nopal and red raspberries are derived.
The Aloe Vera Juice directions of use suggest the consumer drink 2 to 4 fl oz. a day, but the serving size lists 2 fl oz. The serving size listed should be 4 fl oz.
The Buzz Recovery Detox Juice directions of use suggest the consumer take 4 to 8 fl. oz. during and/or after a night of drinking; however, the serving size lists 4 fl. oz. The serving size listed should be 8 fl. oz.
The Diabet-Care directions of use suggest the consumer take 4 capsules with a meal twice daily; however, the serving size lists 1 capsule. The serving size listed should be 4 capsules.
Your Nopalina Flax Seed Plus Fiber product label declares quantitative amount of zero for saturated fat, trans fat, cholesterol and sugars; your Buzz Recovery Detox Juice product label declares quantitative amount of zero for protein; and your Aloe Vera Juice product label declares quantitative amount of zero for total fat, protein and sugars. These (b)(2)-dietary ingredients must not be declared if they are present in amounts that can be declared as zero in accordance with 21 CFR 101.36(b)(2)(i) and 21 CFR 101.9(c).
Your Nopalina Flax Seed Plus Fiber product has incorrectly calculated the percent Daily Value for (b)(2) dietary ingredients, for example, Calcium and Iron, must be calculated as defined in 21 CFR 101.36(b)(2)(iii)(B).
Your Nopalina Flax Seed Plus Fiber product incorrectly declares a percent Daily Value for Omega-3 whereas a Daily Value has not been established for that dietary ingredient. Because of this fact, your product label must declare a symbol for this ingredient that refers to the statement “*Daily Value not Established,” in accordance with 21 CFR 101.36(b)(3)(iv).
Your Nopalina Flax Seed Plus Fiber and Aloe Vera Juice product labels declare 0% Daily Value for (b)(2)-dietary ingredients with established Daily Reference Values where the declared amount is greater than zero. For dietary ingredients for which DRV's have been established, “Less than 1%” or “<1%” must be used to declare the % Daily Value when the quantitative amount of the dietary ingredient by weight is great enough to require that the dietary ingredient be listed, but the amount is so small that the % Daily Value when rounded to the nearest percent is zero, in accordance with 21 CFR 101.36(b)(2)(iii).
Your Buzz Recovery Detox Juice, Nopalina Flax Seed Plus Fiber and Aloe Vera Juice product labels list sodium in the wrong order. Sodium, its quantitative amount by weight per serving, and percent of the daily value should be listed after iron on the Buzz Recovery Detox Juice and Nopalina Flax Seed Plus Fiber labels and after protein on the Aloe Vera Juice label, in accordance with 21 CFR 101.36(b)(2)(i)(B).
Your Buzz Recovery Detox Juice product label lists “Grape juice concentrate 5%.” Amounts of (b)(3)-dietary ingredients shall be expressed using metric measures in accordance with 21 CFR 101.36(b)(3)(ii)(A).
Your Aloe Vera Juice product label claims “Low Calories.” For dietary supplements, claims regarding calories may not be made on products that meet the criteria in 101.60(b)(1) or (b)(2) for "calorie free" or "low calorie" claims except when an equivalent amount of a similar dietary supplement (e.g., another protein supplement) that the labeled food resembles and for which it substitutes, normally exceeds the definition for “low calorie” in 101.60(b)(2).
5. Your dietary supplement products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling on your website is false or misleading. Specifically, your website, www.nopalinausa.com, has the following claim with regard to your dietary supplement products: “Following the provisions of the Civil Procedure of the American Federal Laws, the product has received the Certificate of Good Practice in Manufacturing, given by the Department of Health and Human Services and the Food and Drug Administrations of the United States.” The Department of Health and Human Services does not provide such Certificates of Good Practice in Manufacturing.
Your Diabet-Care product label declares the dietary ingredient “edible cactus” as opposed to the Latin binomial or the standardized common name “prickly pear” as in the reference Herbs of Commerce.
Your Nopalina Flax Seed Plus Fiber product label declares the dietary ingredient “nopal” as opposed to the Latin binomial or the standardized common name “prickly pear” as in the reference Herbs of Commerce.
Your Buzz Recovery Detox Juice product label declares the dietary ingredients “carqueja” and “poleo mint” as opposed to the Latin binomial or the standardized common names “Baccharis trimer”a and “European pennyroyal,” respectively.
Your Buzz Recovery Detox Juice product label declares the dietary ingredients “canchalagua,” “incayuyo” and “vira vira.” These botanical names are not listed in Herbs of Commerce as standardized common names. A botanical ingredient should be declared by the standardized common name noted in Herbs of Commerce or by its Latin binomial name.
7. Your Diabet-Care product is misbranded within the meaning of section 403(s)(2)(A) of the Act [21 U.S.C. §343(s)(2)(A)] in that the label fails to list the name of each ingredient of the supplement that is described in section 201(ff) and the quantity of each such ingredient. For example, your labeling contains ingredient information to suggest that your product contains zinc. However, you do not list this (b)(2)-dietary ingredient and you do not list the quantitative amount by weight per serving and corresponding % Daily Value in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(2).
8. Your Buzz Recovery Detox Juice product is misbranded within the meaning of section 403(s)(2)(A)(ii)(I) of the Act [21 U.S.C. § 343 (s)(2)(A)(ii)(I)] in that the label fails to list the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36. For example, the label declares the dietary ingredient “iron” but fails to include the quantitative amount by weight per serving size.
9. Your Diabet-Care product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Specifically, your product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
The function of the ingredients potassium sorbate in your Buzz Recovery Detox Juice and Aloe Vera Juice products and sodium benzoate and citric acid in your Aloe Vera Juice product is not listed in accordance with 21 CFR 101.22(j).
Your Buzz Recovery Detox Juice product label should not include a heavy bar under the vitamin B12 and before the iron dietary ingredients. Further, the label declares senna leaves tea which is not the common or usual name of an ingredient.
The quantitative amount for sodium must be declared in milligrams (mg) (21 CFR 101.9(c)(4)).
The heading “% Daily Value” and names of the nutrients and the percentage amounts for Total fat, Sodium, Total Carbohydrate, and Protein must be bolded (21 CFR 101.9(d)(1)(iv)).
“Sugars” must be indented (21 CFR 101.9(c)(6)(ii)), and must not declare a percent daily value.
The product labels fail to include the street address of the manufacturer, packer, or distributor as required by 21 CFR 101.5. This may be omitted if shown in a current city directory or telephone directory.
The term “boldo” in the ingredient declaration on the Blood Purifier Tea is not an appropriate common or usual name for boldus (boldo) leaves (21 CFR 172.510(b)).
Ingredient amounts are not permitted as part of the ingredient statement. The percentage of an ingredient may be declared in the statement of ingredients in accordance with 21 CFR 101.4(e).
The product labels for your Blood Purifier Tea, Liver-Gall Bladder Tea, and Urinary System Tea include the term “Herbal Supplement,” which indicates that you intend these products to be dietary supplements. Each of the product labels, however, includes a Nutrition Facts panel rather than a Supplement Facts panel. Because the Nutrition Facts format is used only for conventional foods and dietary supplements must bear nutrition information in the Supplement Facts format [see 101 CFR 101.36], including a Nutrition Facts panel on your product labels represents the products as conventional foods. Under section 201(ff)(2)(B) of the Act [21 U.S.C. 321(ff)(2)(B)], a product that is represented for use as a conventional food does not meet the definition of a dietary supplement. A product that is labeled as a dietary supplement may not also be represented for use as a conventional food. If a product is labeled as a dietary supplement (e.g., by identifying it as an “herbal supplement,” as with your products) but does not meet the definition of a dietary supplement, e.g., because it is represented for use as a conventional food, the product is misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the description of the product as a dietary supplement is false and misleading. Therefore, if you want to market your Blood Purifier Tea, Liver-Gall Bladder Tea, and Urinary System Tea as dietary supplements, these products may not be represented for use as conventional foods (nor, as stated earlier, promoted for intended uses that cause them to be drugs) and, among other requirements, must meet dietary supplement labeling requirements in 21 CFR Part 101 and dietary supplement CGMP requirements in 21 CFR Part 111. For further information about factors we consider in determining whether a product is a conventional food or dietary supplement, see Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages.
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 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your response should be sent to Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case # 481730) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.

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