Inspections, Compliance, Enforcement, and Criminal Investigations
Wholistic Herbs, Inc. 10/5/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
October 5, 2012
UPS OVERNIGHT MAIL
Dong-Rae Park, President
Wholistic Herbs, Inc.
11661 Preston Rd., Ste 170
Dallas, Texas 75230
Dear Dr. Park:
The U.S. Food and Drug Administration (FDA) inspected your facility, located at 11661 Preston Rd., Ste 170, Dallas, TX 75230 from December 28, 2011 through January 10, 2012. During the inspection, our investigators found significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of Sectiqn 402(g)(1) of the Federal Food, Drug and Cosmetic Act (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.
In addition, FDA has reviewed your website at www.wholisticherbs.com. Based on our review, we have concluded that your At Ease product is promoted for conditions that cause the product to be a drug under Section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
FDA has also reviewed the labels for several of your products and has determined that these products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343] in that these labels fail to include required information.
We acknowledge your response dated January 24, 2012, in which you committed to discontinue the following products: Kold & Koff, Kold Sore, and L. Calming Spirit, and to rename the product Stomach Flu. You should send us revised product labels for your Stomach Flu product.
You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
Unapproved New Drug
Examples of some of the claims for your At Ease product on your firm's website at www.wholisticherbs.com/product include the following:
• "We offer alternative solutions, explanations and helpful hints on ... pain, depression, insomnia, arthritis ... We offer effective side-effect management from chemo and radiation therapy."
• "[W]e offer herbal alternatives to depression, ADHA, insomnia, arthritis ... "
• "Our most fantastic product, "At-Ease" assist is battling Depression from an eastern medical perspective."
• '"'At Ease" is highly recommended and effective for those who have found difficulty in taking anti-depressant medications ... "
Your At Ease product is 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)]. Under Section 301(d) and 505(a) of the Act [21 U.S.C. §§ 331 (d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. The introduction into interstate commerce of unapproved new drugs without approved applications violates these provisions of the Act.
Furthermore, your At Ease product is 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, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. 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)].
Even if your At Ease product did not contain disease claims in its labeling that cause it to be a drug, it would still be an adulterated and misbranded dietary supplement, based on the violations for the dietary supplement products you manufacture, as described below.
Dietary Supplement CGMP Violations
1. You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that it manufactured as required by 21 CFR 111.205(a).
Specifically, your firm manufactures dietary supplements but you have not established MMRs in accordance with 21 CFR 111.210 for the dietary supplements that you manufacture.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm was studying to establish MMRs for At-Ease, Morning Calm, Aller-Ban, and Stomach Flu; however, you have not provided a sample document or an expected timeframe for completion.
2. You did not prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a).
Specifically, your firm failed to create a batch record in accordance with 21 CFR 111.260 each time it manufactured dietary supplements. For example, your firm receives dietary ingredients, grinds, blends, and encapsulates, packages, and labels the finished dietary supplements; however, you do not create and maintain any batch records.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm establish a batch production record (b)(4). Your response does not address what will be included in the batch record, nor does it provide an example of a batch record.
3. You did not establish and follow written procedures for quality control operations, as required by 21 CFR 111.103.
Specifically, your firm failed to (a) establish written procedures for required quality control functions and (b) designate personnel at the firm to perform the quality control functions.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm designated Dr. Dong-Rae Park as a quality control officer and will establish a quality control procedure in writing. Your response does not explain what Dr. Park's responsibilities will be in his new role. Further, your response does not indicate a proposed timeframe for when the written quality control procedures will be completed.
4. Your firm did not establish required specifications for points, steps, or stages 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, as required by 21 CFR 111.70(c).
• You failed to establish specifications for dietary supplement labels and packaging, as required by 21 CFR 111.70(d).
• You failed to establish product specifications 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).
• You failed to establish specifications to provide sufficient assurance that the product you receive 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 have reviewed your response, dated January 24, 2012, and found it to be inadequate. You did not provide adequate supporting documents to evaluate your corrective actions.
5. You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i).
Specifically, your firm confirmed that it does not perform testing of the dietary ingredients (raw herbs) to include specific identification or assays before using them to manufacture its finished dietary supplement products.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm found companies that issue a certificate of analysis through the internet and that it will contact them and have them test your firm's products. You also responded that your firm has started to collect samples of raw herbs to confirm the origin of herbs. Your response does not respond adequately to the observation as it cited failure to conduct identity testing of dietary ingredients used to manufacture your firm's dietary supplements, not finished dietary supplement. Further, your response does not explain what methods your firm uses to confirm the origin of each herb.
6. You did not keep the records required for your holding and distributing operations as required by 21 CFR 111.475(b). Specifically:
• Your firm failed to establish written procedures for holding and distributing operations [21 CFR 111.475(b)(1)].
• Your firm does not make and keep records of product distribution for orders placed by customers on your website for the sale of dietary supplements [21 CFR 111.475(b)(2)]. The dietary supplements are packaged and shipped but are not identified on the shipping receipts or documented. For example, your firm could not any documentation relating to orders and shipments for (b)(4) of L. Calming Spirit that were shipped to (b)(4) on 11/23/11; (b)(4) of L. Calming Spirit that were shipped to (b)(4) on 8/12/11; and (b)(4) of L. Calming Spirit and (b)(4) of Morning Calm that were shipped to (b)(4) on 10/6/10.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm will make sure all invoices will be issued and properly filed in an orderly manner and that procedures for holding and distribution operations will be included in the standard operation procedure; however, you have not provided a copy of the written procedures.
7. You have not assigned qualified personnel to supervise the manufacturing, packaging, labeling, and holding of dietary supplements, as required by 21 CFR 111.13(a).
Specifically, your firm has not assigned qualified personnel to supervise the grinding of the herbs, blending of the formulas, encapsulation, and packaging of the finished herb blend formulas. Your firm's office manager also works unsupervised and has not received training to work with dietary supplements.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm will review and rewrite the procedure. It is unclear in your response as to what procedure your firm is referencing and a copy of the procedure was not provided. In addition, your response stated that your firm will have a better supervision system and training. Your response does not explain what the supervision system will consist of and the type of employee training that will take place, or who will conduct the training.
8. You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint, as required by 21 CFR 111.553 and 111.570.
Specifically, your firm has not established written procedures or a system for recording product complaints received for the dietary supplements it manufactures. For example, your firm's office manager confirmed that your firm has received returned dietary supplements from patients or customers, which are generally accompanied by a complaint or reason for return; however there is no written procedure on how to handle a complaint and there is no investigation conducted.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm will make a log book for any complaints immediately and also make a record of returned dietary supplements. Your response does not address whether your firm plans to develop written procedures for complaint review and investigations.
9. You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements, as required by 21 CFR 111.503 and 111.535.
Specifically, your firm failed to establish written procedures to address the steps to be followed [21 CFR 111.510, 111.515, 111.520, 111.525, 111.5301 when a distributed dietary supplement has been returned by a patient or customer.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that it will write a policy and procedure for returned products. Your response does not provide a draft of the procedure or explain how the procedure will address handling of returned dietary supplements.
10. You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed, as required by 21 CFR 111.83.
Specifically, your firm does not collect reserve samples of any of the dietary supplement products that you distribute under the brand name of Wholistic Herbs, Inc.
We have reviewed your January 24, 2012 response and find it to be inadequate. You responded that your firm will "start collecting and reserving final products for any inspection required for (b)(4) and collecting (b)(4) of final blended dietary supplements." Your response does not explain if the reserve samples will be held using the same container-closure system in which the finished products were packaged and distributed, as required by 21 CFR 111.83(b)(1). Further, your response does not explain whether collecting a reserve sample of (b)(4) is sufficient to ensure that you have at least twice the quantity necessary for all tests or examinations to determined whether the dietary supplement meets product specifications, as required by 21 CFR 111.83(b)(4).
Misbranded Dietary Supplements
Your At-Ease, Aller-Ban, Stomach Flu, and Morning Calm products are misbranded under Section 403(s)(2)(8) of the Act [21 U.S.C. § 343(s)(2)(8)] in that the product labels fail to identify the product using the term "dietary supplement" in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term "dietary supplement" as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product.
Your At-Ease, Aller-Ban, Stomach Flu, and Morning Calm products are misbranded under Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the product labels fail to include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.
Your At-Ease, Aller-Ban, Stomach Flu, and Morning Calm products are misbranded under Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] and in accordance with 21 CFR 101.36 in that the product labels fail to list botanical dietary ingredients directly below those dietary ingredients with an established daily recommended value (DRV) or recommended daily intake (RDI) within the supplement facts panel along with the quantitative amount by weight per serving of either the proprietary blend or each botanical dietary ingredient.
Your At-Ease, Aller-Ban, Stomach Flu, and Morning Calm products are misbranded under Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] and in accordance with 21 CFR 101.4(g) in that the product labels fail to include capsule ingredients in the ingredients list. The term "ingredients" followed by a listing of ingredients that are not dietary ingredients should be located outside the supplement facts panel and immediately below or contiguous and to the right of the nutrition information of the supplement facts panel in accordance with 21 CFR 101.4(g).
The above is not intended to be an all-inclusive list of violations in connection with your products. You should take prompt action to correct all violations. It is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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 reinspectionrelated 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)). 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.
In addition to the violations listed above, we have the following comment:
• Your firm's manufacturing operations are performed at an off-site location (a (b)(4) structure) at (b)(4) of your (b)(4) You informed our investigator that your firm performs grinding and blending of herbs at this location. Please be advised that any physical plant you use in the manufacture, packaging, labeling, or holding of dietary supplements must be suitable in size, construction, and design to facilitate maintenance, cleaning, and sanitizing operations, and the other requirements of 21 CFR Part 111. You must also implement production and process controls for any operations conducted at this off-site location.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. You may include any documentation necessary (including labels) to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your written response should be sent to Thao Ta, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Mr. Ta at (214) 253-5217.
Reynaldo R. Rodriguez, Jr.
Dallas District Director