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

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312··353-5863

 

April 8, 2016
 
WARNING LETTER
 
CHI-5-16
 
VIA UPS NEXT DAY
SIGNATURE REQUIRED
 
Dr. Hector P. Oliva
President and Owner
Salud Natural Entrepreneurs, Inc.
1120 Glenrock Avenue
Waukegan, Illinois 60085
 
Dear Dr. Oliva:
 
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 pageat www.fda.gov.
 
Unapproved New Drugs and Misbranded Drugs
 
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.
 
Examples of some of the label and website claims that provide evidence that your products are intended for use as drugs include: 
 
Aloe Vera Juice
Urinary System Tea
Nopalina Flax Seed Plus Fiber (sold in powder and capsule form)
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 
Overweight and Cholesterol Kit 
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.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
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)].
 
Adulterated Dietary Supplements
 
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).  
 
During our inspection, our investigator observed the following violations, which were noted on FDA Form 483, Inspectional Observations, which was issued at the close of the inspection on July 6, 2015. We received your written response to these observations on January 27, 2016, and we address this response below, in relation to each of the noted violations. The significant violations documented during the inspection include, but are not limited to, the following:
 
1.    You failed to establish the required specifications for points, steps, or stages in the manufacturing process where control is necessary 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 111.70(a). Specifically, you failed to establish:
 
a.  The following component specifications for each component that you use in the manufacture of a dietary supplement:
 
i.  Identity specifications [21 CFR 111.70(b)(1)];
 
ii.  Component specifications that are necessary to ensure that specifications for the purity and strength of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)];
 
iii.  Limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)(3)];
 
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.
 
Misbranded Dietary Supplements
 
1.    Your Parasitos, Aloe Vera Juice, Diabet-Care, and Nopalina Flax Seed Plus Fiber products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. For example,
2.    Your Parasitos, Aloe Vera Juice, Nopalina Flax Seed Plus Fiber, Diabet-Care and Buzz Recovery Detox Juice products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C.  § 343(s)(2)(C)] )] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the products are derived, as required by 21 CFR 101.4(h)(1). For example:
3.    Your Aloe Vera Juice, Buzz Recovery Detox Juice, and Diabet-Care products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. 343(q)(1)(A)] because the serving sizes declared on the labels are incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. For example:
4.    Your Aloe Vera Juice, Nopalina Flax Seed Plus Fiber, and Buzz Recovery Detox Juice products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. For example:
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.
 
6.    Your Nopalina Flax Seed Plus Fiber, Diabet-Care and Buzz Recovery Detox Juice products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product labels fail to declare the common or usual name or Latin binomial of each ingredient used as required by 21 CFR 101.4(h). For example,
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 violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA 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, without limitation, seizure and injunction.
 
We offer the following additional comments:
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.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
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.
 
Sincerely,
/S/
William R. Weissinger
District Director


This page was posted on March 28, 2019.

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