Dear Mrs. Irons:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 705 McGee St., Kansas City, Missouri, on May 8 through May 15, 2014. During the inspection, our investigators collected labeling for several of your products, which Vitalab Co., Inc. (Vitalab) manufactures, repacks, and labels as dietary supplements for sale by three distributors: V.E. Irons, Inc., Springreen Products, Inc., and Sonne's Organic Foods, Inc. According to statements you made during a telephone call with our investigators, you own the three distributor companies in addition to Vitalab, and all four companies are run as a single enterprise. Based on our review of your product labeling and the websites of your three distributor companies, we have concluded that your "Vit-Ra-Tox #16 Detoxiticant" (also marketed under the names "Springreen #77 Detoxiticant" and "Sonne's #7 Detoxiticant") and "Vit-Ra-Tox #38 Calphonite" products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(B)). As explained further below, introducing or delivering these products for introduction into interstate commerce violates section 301(d) of the Act (21 U.S.C. § 331 (d)].
Our inspection also revealed serious violations of FDA's regulations for Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, which are found in Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplements you manufacture 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 that do not meet cGMP requirements for dietary supplements. In addition, based on our review of your product labeling, your "Springreen No. 88 Whole Beet Plant Juice" (also marketed under the names "Vit-Ra-Tox No. 48 Whole Beet Plant Juice" and "Sonne's No. 18 Whole Beet Plant Juice") and your "Springreen No. 30 SPRINGREEN" (also marketed under the names "Sonne's No. 10 greenlife" and "Vit-Ra-Tox No. 22 greenlife") are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements of the Act and FDA's regulations in 21 CFR Part 101. You may find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA 483 detailing our investigators' observations during the inspection. We received your letter containing responses to those observations on June 9, 2014. Because the observations on the Form FDA 483 and your responses all relate to compliance with the cGMP regulations for dietary supplements, we discuss our assessment of your responses in the cGMP section of this letter (entitled "Adulterated Dietary Supplements").
The inspection and our review of your websites and product labeling revealed the following significant violations:
Unapproved New Drugs
We have reviewed the labeling of your products, as well as the websites (www.veirons.com, www.sonnes.com, and www.springreen.com/)1 and Facebook pages (www.facebook.com/veirons and www.facebook.com/sonnesorganicfoods)2 of your distributor companies. You take orders on the Sonne's website for several of your products, including your Vit-Ra-Tox #16 Detoxificant and Vit-Ra-Tox #38 Calphonite. The websites and Facebook pages of your distributor companies contain claims about the use of your Vit-Ra-Tox #16 Detoxificant and Vit-Ra-Tox #38 Calphonite for conditions that cause the products to be drugs under section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your companies' websites and Facebook pages establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
Examples of some of the website and Facebook claims that provide evidence that your Vit-Ra-Tox #16 Detoxificant, which includes bentonite as an ingredient, is intended for use as a drug include:
• "[B]entonite clay was used by the British Army in India to treat acute bacterial food poisoning and in China to help treat cholera."2
• "[B]entonite, the Detoxificant's main ingredient, has been used to rid the body of bacteria (such as ecoli and staph), viruses, parasites .... "3
• "SAFE REMOVAL OF: Chemicals, Bacteria, Viruses, Heavy Metals, Metabolic Toxins..."4
An example of a Facebook claim that provides evidence that your Vit-Ra-Tox #38 Calphonite is intended for use as a drug is:
• "[A]ssists the body in ... helping repair broken bones! "5
Your Vit-Ra-Tox #16 Detoxificant and Vit-Ra-Tox #38 Calphonite 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 introduced or delivered for introduction 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.
Adulterated Dietary Supplements
During the inspection of your facility, investigators observed serious violations of the dietary supplement cGMP regulations, as described below. These violations cause your dietary supplement products to 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 CGMP regulations for dietary supplements in 21 CFR Part 111.
We acknowledge receipt of your FDA-483 response dated June 6, 2014. An inspection will be made at a later date to determine if the promised corrections have been made and are effective.
1. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement you manufacture, as required in 21 CFR 111.205(a). Specifically, your firm does not have a master manufacturing record for any of the dietary supplements you manufacture, including, but not limited to, the following:
• Springreen No. 30 SPRINGREEN (Lot # 02-03-16-2)
• Sonne's No. 17 NATURAL SOURCE VITAMIN C (Lot# 01-22-16-3)
• Sonne's Whole Beet Plant Juice No.18 (also marketed under the names "V.E. Irons Whole Beet Plant Juice No. 48" and "Springreen Whole Beet Plant Juice No. 88"- all were from Lot# 06-11-15-2)
Please note that each MMR must include the elements specified in 21 CFR 111.210.
In your response to the Form FDA 483, you stated that you are developing written MMRs for each unique formulation and batch size of dietary supplement you manufacture. Our review determined your response to be inadequate because you failed to provide supporting documents or examples of your corrections.
2. You failed to establish 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 MMR, as required by 21 CFR 111.70(a).
• You failed to establish specifications for the identity of components as required by 21 CFR 111.70(b)(1). You a] so failed to establish component specifications necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
• You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of 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 in accordance with 21 CFR 111.95(b).
Your response letter indicated that you are working to develop SOPs for establishing component specifications and specifications for each finished batch of dietary supplements. However, our review determined your response to be inadequate because you failed to provide supporting documents or examples of specifications you have established.
3. You failed to establish and follow written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103, including written procedures for conducting a material review and making a disposition decision. For example, you do not have written procedures to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the MMR, in accordance with 21 CFR 111.105.
Your response indicated that you intend to establish written procedures for quality control operations. However, our review determined your response to be inadequate because you failed to provide supporting documentation or examples of written quality control procedures you have established.
4. Your batch production records (BPR) for the Springreen No. 30 SPRINGREEN (Lot# 02-03-16-2), Sonne's No. 17 NATURAL SOURCE VITAMIN C (Lot# 01-22-16-3), and Sonne's Whole Beet Plant Juice No. 18 products failed to include documentation (signatures and approval dates) that quality control personnel reviewed the BPR, including review of required monitoring operations and review of the results of tests and examinations (e.g., results of taste and hardness tests), as required by 21 CFR 111.260(l)(1).
In your response, you indicated that you have revised your SOPs to clarify when quality control checks of test results are required and that you intend to train your quality control personnel to properly document their review of the BPR. However, your response is inadequate because you failed to provide supporting documentation or examples (e.g., revised SOPs or records of staff training) to demonstrate that you are implementing these planned corrections.
5. You failed to periodically re-confirm the supplier's certificate of analysis (COA) for a component as required by 21 CFR 111.75(a)(2)(ii)(D). Specifically, during the inspection we observed (b)(4) boxes of rejected "Aloe powder" that did not pass quality control review. The supplier's COA for this ingredient reflected a yeast/mold count of (b)(4) CFUs/gram, even though your firm's specification was (b)(4) CFUs/gram. We were later told by your firm that the only time a supplier's COA is checked is when there is a change in supplier. Thus, your firm is not periodically reconfirming your supplier's COA. The last time your firm tested the "Aloe powder" ingredient (by sending it to (b)(4) for verification and qualification) was on August 9, 2010. We note that your firm has not tested any other raw ingredients to confirm the supplier's COA since approximately 2010.
Your response indicated that you would work with your consultant to conduct a risk assessment of your components and suppliers and, based on that assessment, would evaluate whether Vitalab should re-confirm its suppliers' COAs more frequently. However, your response is inadequate because you failed to provide evidence that you are re-confirming supplier COA results at any frequency for current components received. You are required to periodically reconfirm the supplier's COA with sufficient frequency to ensure that applicable component specifications established in accordance with § 111.70(b) are met [see 21 CFR 111.75(a)(2)(ii)(D)].
6. You failed to comply with the requirements for records of product complaints in 21 CFR 111.570. Under 21 CFR 111.570(b)(2)(ii)(F), the written record of a product complaint must include the findings of the investigation and follow-up action taken when an investigation is performed. Your adverse event report dated 7/6/2012 did not contain documentation of any investigation of the root cause of the reported illness.
Your response indicated that you intend to document the investigation of the root cause of the adverse event dated 7/6/2012. However, your response is inadequate because you failed to provide supporting documentation or examples to demonstrate that you are implementing this correction.
7. You failed to establish written procedures for the requirements for components, packaging, and labels and for products that you receive for packaging or labeling as dietary supplements, as required by 21 CFR 111.153. These written procedures must meet the requirements in 21 CFR 111.170. During the inspection, our investigators observed rejected components (specifically, (b)(4) boxes of "Aloe Powder" (Lot #(b)(4)) and (b)(4) box of"Papaya Powder" (no lot number)) that were not clearly identified, held, and controlled under a quarantine system for appropriate disposition, as required by 21 CFR 111.170.
In your response, you indicated that you intend to establish procedures for rejected components, packaging, and labels, and that these procedures will require the use of a sign to identify materials that are quarantined. However, your response is inadequate because you failed to provide supporting documentation or examples to demonstrate that you are implementing this correction.
8. You failed to establish written procedures for calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.25(a). Specifically, you do not have written procedures for the calibration of any of the scales used in the production area, including the scale ((b)(4)) used to weigh amber plastic bottles that hold Wheat Germ Oil Gel Capsules.
Your response stated that you calibrated your scales on May 16, 2014, and provided documentation of that calibration. You further stated that you intend to establish written procedures for calibrating instruments. However, our review determined your response to be inadequate because you failed to provide supporting documentation or examples of written calibration procedures you have established.
Misbranded Dietary Supplements
Your "Springreen No. 88 Whole Beet Plant Juice" and "Springreen No. 30 SPRINGREEN" products are misbranded under section 403 of the Act [21 U.S.C. § 343) because they do not comply with FDA's labeling regulations under 21 CFR Part 101.
1. Your Springreen No. 88 Whole Beet Plant Juice and Springreen No. 30 SPRINGREEN products are misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is misleading because it fails to state a material fact [see 21 U.S.C. § 321 (n)). Specifically, the labels of these products fail to bear the following warning statement about the risk of fatal poisoning in children under 6:
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, calf a doctor or poison control center immediately.
Dietary supplements in solid oral dosage form that contain iron or iron salts are required to bear this warning statement [see 21 CFR 101.17(e)]. The labels on your Springreen No. 88 Whole Beet Plant Juice and Springreen No. 30 SPRINGREEN products, which are in tablet form, declare iron as an ingredient. However, the labels do not include the warning statement required by § 101.17(e).
2. Your Springreen No. 30 SPRINGREEN product is misbranded within the meaning of section 403(1)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients and the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4.
Specifically, the Batch Production Worksheet collected during the inspection showed that oats, rye, and wheat cereal grasses are ingredients in your Springreen No. 30 SPRINGREEN product; however, oats, rye, and wheat cereal grasses are not listed in the ingredient statement.
3. Your Springreen No. 88 Whole Beet Plant Juice product is misbranded within the meaning of Section 403(q)(1)(A)(i) of the Act [21. U.S.C. § 343(q)(1)(A)(i)], because the product label failed to list the serving size according to the maximum amount recommended on the label for consumption per eating occasion, in accordance with 21 CFR 101.12(b) [Table 2, "Miscellaneous Category," "Dietary supplements"]. Specifically, your label states a suggested use of "two to eight tablets daily"; however, your serving size is listed as "4 tablets." As such, the nutrition information should be based on the suggested use of 8 tablets.
The violations cited in this letter are not intended to be an all-inclusive list 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 enforcement action without further notice, including, without limitation, seizure and injunction.
In addition, we have the following comments:
• During the inspection, our investigator observed that your employees who engage in manufacturing and quality control operations are not familiar with dietary supplement cGMP requirements and do not understand how to establish and follow quality control procedures. Under 21 CFR 111.12(c), personnel engaged in manufacturing and quality control operations must have the education, training, or experience to perform their assigned functions.
• You stated to our investigator that you assign an expiration date two years from the manufacturing date of the product. The expiration date is included in the manufacturing lot code on the bottle cap. Please note that any expiration date, shelf life date, or "Best if used by" date you place on a product label should be supported by data. [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007).]
Within fifteen 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.
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 re-inspection-related costs.
Your written response should be sent to Danial S. Hutchison, Compliance Officer, U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214. If you have questions regarding any issues in this letter, please contact Mr. Hutchison at (913) 495-5154 or Danial.Hutchison@fda.hhs.gov.
Cheryl A. Bigham
Kansas City District
Ms. Gloria J. White, Manager Q/C
Vitalab Co:, Inc.
705 McGee St.
Kansas City, MO 64106