Inspections, Compliance, Enforcement, and Criminal Investigations
Iowa Select Herbs 4/18/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214-1524
Telephone: (913) 495-5100
April 18, 2014
RETURN RECEIPT REQUESTED
Ref. CMS# 410468
Gordon L. Freeman, CEO/President
Iowa Select Herbs, LLC
2347 Blairs Ferry Rd., NE, Suite 2
Cedar Rapids, Iowa 52402
Dear Mr. Freeman:
On August 14 through August 21, 2013, the United States Food and Drug Administration (FDA) investigators inspected your facility located at 2347 Blairs Ferry Rd., NE, Suite 2, Cedar Rapids, Iowa 52402. We also reviewed your firm’s website at www.iowaselectherbs.com in March 2014 and have determined that you take orders there for several of your products, including your Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract products. Based on the inspection and our review, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drug
Based on our review of your product labeling on your firm’s website at www.iowaselectherbs.com we have determined that your Flax Seed, Holy Basil, Papaya Leaf Extract, and Ginkgo Leaf Extract 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 your website establish that the products are drugs because they are intended for use in the diagnosis, 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 website claims that provide evidence that your products are intended for use as drugs include:
- “Flax Seed, and the omega-3’s contained within it have been credited with preventing, curing, and treating a number of diseases and conditions. Everything from cancer to diabetes to constipation to heart conditions to arthritis …”
- “Treats many intestinal and chest conditions such as chronic cough and bronchitis.”
- “[F]laxseed is one of the best vegan sources of Omega-3 (ALA) … Having the right balance of essential fatty acids has been shown to be a strong factor in preventing heart disease and lessening the impact of rheumatoid arthritis and other autoimmune disorders.”
- “Holy basil can be used for the common cold, influenza (“the flu”), H1N1 (swine) flu, diabetes, asthma, bronchitis, earache, headache, stomach upset, heart disease… viral hepatitis, malaria, and tuberculosis.”
- “It is also used for mercury poisoning … and to counteract snake and scorpion bites”
Papaya Leaf Extract
- “Papaya Leaf Extract … slows cancer growth.”
- “[P]apain enzyme is the best defense for reducing the growth of cancer cells …”
Ginkgo Leaf Extract
- “[H]elp[s] treat and prevent Alzheimer’s disease.”
- “Ginkgo leaf extracts is used … to treat or help prevent Alzheimer’s disease and other types of dementia; to decrease intermittent claudication (leg pain caused by narrowing arteries); and to treat sexual dysfunction, multiple sclerosis, tinnitus …”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment or prevention of disease. Examples of such testimonials include:
- “My brother developed idiopathic thrombocytopenia and very low platelets which was down to 7,000. Nearly dying despite expensive treatments. We started papaya extract and his platelets jumped to 52,000 after 3 months. Six weeks later his platelets are 120,000. Ramatu, IL.”
- “I am a 42 year old male diagnoised [sic] with ITP (Idiopathic thrombocytopenic purpura). Since starting papaya extract I have been able to come completely off. I am maintaining a count of 94K! This product has been a miracle for me! Mike, Illinois”
- “I was diagnoised [sic] with ITP and end up in hospital for loew [sic] platelet counts. Since taking the papaya leaf extract my platelets increased from 76 to 114 Rob, Indiana”
Claims that establish the intended use of products as drugs were also observed on the labeling accompanying shipments of your finished products, including the following:
- “Papa leaf [an ingredient in your Papaya Leaf Extract product] extract may slow growth of cancerous tumors, according to new research”
- “Papaya leaf extract may be the newest cancer-fighting superfood …”
- “Papaya leaf extract, and tea made from the extract, contain major cancer-fighting properties, according to new research. Papaya was able to slow the growth of tumors in the breast, lung, pancreas, cervix and liver …”
- “The researchers found that the effects of the dried papaya leaf extract were stronger when the cancer cells exposed to it received larger doses of papaya”
The products identified above are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. §321(p)(1)]. New drugs may not be legally introduced or delivered 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 products, Papaya Leaf Extract, Ginkgo Leaf Extract, Holy Basil, and Flax Seed 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, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)].
Dietary Supplement CGMP Violations:
Even if the labeling for your Papaya Leaf Extract, Ginkgo Leaf Extract, Holy Basil, and Flax Seed products did not make therapeutic claims, which make the products unapproved new 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 (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Further, all other dietary supplement products your firm manufactures are adulterated within the meaning of section 402(g)(1) of the Act for the same reason.
Specifically, during the inspection, investigators observed the following significant violations:
1. You failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(a). Specifically:
- You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b).
- You failed to establish in-process specifications for any point, step, or stage in the master manufacturing record where control is necessary to ensure specifications are met for the identity, purity, strength, and composition of the dietary supplements, as required by 21 CFR 111.70(c)(1).
- You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with the dietary supplements, as required by 21 CFR 111.70(d).
- You failed to establish specifications to provide sufficient assurance that the product you receive from a supplier for packaging and labeling as a dietary supplement is adequately identified and is consistent with the purchase order, as required by 21 CFR 111.70(f).
- You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, as required by 21 CFR 111.70(g).
We note that once you have established the above specifications, you must determine whether the specifications have been met as required by 21 CFR 111.73. We also note that you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
2. You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, your firm manufactures dietary supplements; however, you do not perform any test or examination to verify the identity of the dietary ingredients used in the manufacturing of your dietary supplements. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements of 21 CFR 111.75(a)(1)(ii), and FDA has granted such petition. Your firm has not petitioned FDA for such an exemption.
3. You failed to confirm the identity of components other than dietary ingredients by either conducting appropriate tests or by qualifying the supplier of the component, as required by 21 CFR 111.75(a)(2). Specifically, your firm does not test components or qualify your suppliers prior to using components received by them to use in the manufacture of dietary supplements.
4. You failed to collect any representative samples from each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet established specifications, as required by 21 CFR 111.80(a).
5. You failed to quarantine components prior to their use in the manufacture of dietary supplements, as required by 21 CFR 111.155(c).
6. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufactured as required by 21 CFR 111.205(a). Specifically, your firm manufactures and repackages dietary supplements but you have not established MMRs, as required by 21 CFR 111.205(a). In addition, we note that an MMR must include certain information, as specified in 21 CFR 111.210.
7. You failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. Specifically, during the inspection our investigators found your firm failed to create any written quality control operations procedures for any and all aspects of the dietary supplement manufacturing/repackaging operations to assure the quality, identity, purity, strength, composition, and safety of the dietary supplement manufactured throughout all steps of the manufacturing/repackaging process.
8. You failed to identify personnel to be responsible for quality control operations, as required by 21 CFR 111.12(b). You are required to ensure each person who is identified to perform quality control operations is qualified to do so and has distinct and separate responsibilities related to performing such operations from those responsibilities the person otherwise has when not performing such operations.
9. You failed to have quality control operations for components, packaging, and labels before use in the manufacture of dietary supplements, as required by 21 CFR 111.120.
Specifically, during the inspection our investigators found quality control operations that ensure quality dietary supplement production are not in place. For example:
- Received components, packaging, and labeling are not reviewed to determine conformity to established specifications;
- Material review and disposition decisions are not completed;
- Approval/rejection of treatments and in-process adjustments of components, packaging, and labels to make them suitable for use in manufacturing dietary supplements is not controlled; and
- Approving and releasing from quarantine components, packaging, and labels before they are used is not performed.
10. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that are distributed, as required by 21 CFR 111.83(a).
11. You failed to calibrate instruments and controls used in manufacturing or testing a component or dietary supplement at the frequency specified in writing by the manufacturer of the instruments and controls or at routine intervals or as necessary to ensure the accuracy and precision of the instruments or controls, as required by 21 CFR 111.27(b). Specifically, during the inspection our investigators found the firm does not routinely calibrate the onsite scale to verify its accuracy.
Misbranded Dietary Supplements
Further, even if the labeling for your Papaya Leaf Extract, Ginkgo Leaf Extract, Holy Basil, and Flax Seed products did not make therapeutic claims, which make these products unapproved new drugs, they would also be misbranded within the meaning of section 403(q)(5)(F)) of the Act [21 U.S.C. 343(q)(5)(F)] in that the product labels fail to present nutrition information, ( “Supplement Facts” panels), as required by 21 CFR 101.36.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable FDA regulations, including the CGMP regulation for dietary supplements. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within 15 working days of receiving this letter. Your response should include each step which has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating corrections have been made.
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related costs.
Your response should be sent to Jessica E. Hensley, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 8050 Marshall Drive, Suite 205, Kansas 66214. If you have any questions about this letter, please contact Compliance Officer, Jessica E. Hensley at 913-495-5183.
David L. Miser
Acting District Director
Kansas City District Office