Inspections, Compliance, Enforcement, and Criminal Investigations

Sound Healing Arts, PC DBA Grounds for Tea LLC 10/16/15

  

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

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
 
Telephone:      425-302-0340
           FAX:      425-302-0402

 

October 16, 2015
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply refer to Warning Letter SEA 16-01
 
Anthony Calpeno, President
Sound Healing Arts, PC, dba Grounds for Tea, LLC
7702 Cirque Drive West
University Place, Washington 98467
 
WARNING LETTER
 
Dear Mr. Calpeno,
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility located at 7702 Cirque Drive West, University Place, Washington  98467, on December 16, and 19, 2014, and January 6, and 20, 2015. During the inspection we collected labeling for your products. Based on our inspection and subsequent review of your product labeling, including your firm’s website and www.Amazon.com product listings, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov. 
 
The inspection and our review of your product labeling revealed the following significant violations:
 
Unapproved New Drugs
 
FDA reviewed your website at www.naturaldoctor.com in October 2015 and has determined that you take orders for your NaturalDoctor Vitamins C & K3 / 100:1TM; NaturalDoctor Goldenseal & Echinacea PlusTM; NaturalDoctor Centella Skin and Veins TM; NaturalDoctor Organic Artemisia Plus TM; NaturalDoctor Organic Dong Quai Plus TM; NaturalDoctor Organic Dandelion Plus TM; NaturalDoctor Vitex PMSTM; and NaturalDoctor St. John’s Mood PlusTM products, which the website promotes 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 the website and the revised NaturalDoctor finished product labels provided during the inspection establish that these products are drugs 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 claims that provide evidence that your products are intended for use as drugs include:
 
NaturalDoctor Vitamins C & K3 / 100:1TM
Website:
  • “This remedy treats a variety of malignancies...including:…Breast…Cervix…Colon…Liver…Oral Squamous Cell…Nasopharyngeal…Prostate…Stomach…Testicals…Urological (Kidney, Transitional & Squamous Cell Bladder, & Androgen-Independent Prostate)…Uterine…Adriamycin…Leukemia…Lymphoma…”
NaturalDoctor Goldenseal & Echinacea PlusTM
Product label:
  • “Benefits: Acute or chronic mucous membrane conditions: common cold, sinusitis, bronchitis, tonsillitis, chronic constipation,…diarrhea and cystitis.” 
Website:
  • “BOILS, CARBUNCLES AND ABCESSES…ANTI-MICROBIAL…ANTI-INFLAMMATORY…ANTIFUNGAL AND ANTIPROTAZOAL EFFECTS…ANALGESIC…”  
NaturalDoctor Centella Skin and VeinsTM
Product label:
  • “[K]eloids, ulcers, wounds & burns…Hemorrhoids…Diabetic skin complications…After head trauma.” 
Website:
  • “KELOIDS… STROKE PREVENTION…LEG OR FOOD [sic] ULCER…AFTER WOUNDS, BURNS OR SURGERY…CHRONIC HEMORRHOIDS...DIABETES MELLITUS TO PROTECT MICRO VASCULAR CIRCULATION...HEAD TRAUMA…3RD(CHARRING OR LOSS OF SKIN) DEGREE BURNS…STOMACH, DUODENAL OR SKIN ULCERS…LEG OR ANKLE EDEMA…ANTI-INFLAMMATORY…”
NaturalDoctor Organic Artemisia PlusTM
Product label:
  • “PMS with excessive flow…”
Website:
  • “GASTROINTESTINAL INFECTIONS… AMOEBIC DYSENTERY…ENTAMOEBA HYSTOLYTICA…FUNGAL/YEAST CANDIDA ALBICANS…PAPILLOMAVIRUS…HEPATITIS B…GIARDIA LAMBLIA…MALARIA…SHISTOSOMA SPECIES…BACILLUS (Cereus …)…chlamydia…SMALL INTESTINE INFECTIONS…DIGESTIVE INFLAMMATIONS DUE TO INFECTIONS, WITH FEVER & OR BLEEDING…IRRITABLE BOWEL SYNDROME…ENLARGED SPLEEN…GASTRIC ULCERS… GALL BLADDER STONES…JAUNDICE…DRUG RESISTENT MALARIA…CANCER SUPPORT: BRAIN (GLIOMAS), BREAST, COLON, DRUG RESISTANT CANCERS…KIDNEY, SMALL CELL LUNG, LEUKEMIA, ORAL/LARYNGEAL SQUAMOUS CELL, PROSTATE, OVARY AND SKIN CANCERS…”
NaturalDoctor Organic Dong Quai PlusTM
Product label:
  • “[P]ainful, irregular or lack of menses, infertility, chronic pelvic infections…Chronic liver conditions. Tinnitus…Allergy.”
Website:
  • “TINNITUS…BLURRED VISION…LOWERS HIGH BLOOD PRESSURE… HEART PALPITATIONS…AIDS CHRONIC KIDNEY FAILURE…CHRONIC HEPATITIS OR LIVER CIRRHOSIS…CONSTIPATION…HEADACHES… ARTHRITIS…TRAUMA…RELIEVE ALLERGIES…IRREGULAR MENSES, LACK OF MENSES OR PAINFUL MENSES, INFERTILITY CHRONIC PELVIC INFECTIONS…PREMENSTRUAL SYNDROME…PREVENTS BLOOD CLOTS…REDUCES ANEMIA…IS 1.7 TIMES STRONGER THAN ASPIRIN WITHOUT THE END ORGAN DAMAGE…ANTICANCER AND ANTIBACTERIAL EFFECTS…”
NaturalDoctor Organic Dandelion PlusTM
Product label:
  • “[C]hronic bladder infections…”
Website:
  • “PREVENT AND TREAT LIVER, GALLBLADDER, SPLEEN, KIDNEY AND JOINT PROBLEMS…SKIN CONDITIONS…HEARTBURN AND FLUID RETENTION…GOUT…ECZEMA…CONSTIPATION…ADJUVANT IN ANY CHRONIC CONDITION SUCH AS OSTEOARTHRITIS, RHEUMATOID ARTHRITIS, GALLSTONES AND KIDNEY STONES…CYSTITIS…”
NaturalDoctor Vitex PMSTM
Website:
  • RELAXES MUSCLE SPASMS AND CRAMPS IN ABDOMEN AND UTERUS…RELIEVES HEADACHES…PREVENTS BLOOD CLOTS…ANTISPASMODIC…ANTI-INFLAMMATORY…RELIEVES RESTLESSNESS AND NERVOUSNESS…RELIEVES BREAST PAIN…DYSFUNCTIONAL UTERINE BLEEDING AND INFERTILITY… INSOMNIA…”  
NaturalDoctor St. John’s Mood PlusTM
Website:
  • “DEPRESSION…HERBS FOR THE SAFE AND EFFECTIVE MANAGEMENT OF LIFE?S [sic] MAJOR AND MINOR TRIBULATIONS… ALCOHOLISM…DEPRESSION IN CHILDREN…ANXIETY WITH DEPRESSION…MENOPAUSAL DEPRESSION…SEASONAL AFFECTIVE DISORDER…MILD, MODERATE AND MAJOR DEPRESSIONS…SAFE FOR USE DURING PREGNANCY AND LACTATION…PROVEN BY NUMEROUS TRIALS TO BE AS EFFECTIVE IN AIDING MILD TO MAJOR DEPRESSION AS PAXIL, ZOLOFT AND PROZAX WITH VIRTUALLY NO SIDE EFFECTS…”
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 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.
 
Furthermore, your NaturalDoctor Vitamins C & K3 / 100:1TM; NaturalDoctor Goldenseal & Echinacea PlusTM; NaturalDoctor Centella Skin and Veins TM; NaturalDoctor Organic Artemisia Plus TM; NaturalDoctor Organic Dong Quai Plus TM; NaturalDoctor Organic Dandelion Plus TM; NaturalDoctor Vitex PMSTM; and NaturalDoctor St. John’s Mood PlusTM products 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 your NaturalDoctor Vitamins C & K3 / 100:1™; NaturalDoctor Goldenseal & Echinacea Plus™; NaturalDoctor Centella Skin and Veins™; NaturalDoctor Organic Artemisia Plus™; NaturalDoctor Organic Dong Quai Plus™; NaturalDoctor Organic Dandelion Plus™; NaturalDoctor Vitex PMS™; and NaturalDoctor St. John’s Mood Plus™  products did not have therapeutic claims which make them drugs, these products that you manufacture, repackage, and/or distribute are adulterated dietary supplements under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that these products have been prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).  In addition, 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 our inspection, our investigator observed the following violations which were noted on the Form FDA 483, Inspectional Observations, issued to you on January 20, 2015. We received your written response dated February 4, 2015, to the Form FDA 483, Inspectional Observations. 
 
Our inspection revealed the following violations:
 
1.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103.
 
We have reviewed your response letter, dated February 4, 2015, and have determined that your response is not adequate. Your response indicated that you have committed to write procedures to ensure compliance with “current dietary supplement GMPs to include: receiving, repacking, labeling, storage, distribution, and complaints” for all powdered and encapsulated products. However, it is not clear that the promised new procedures will describe the responsibilities of the quality control operations to include conducting and documenting material review and disposition decisions. No example documentation was provided, and you do not describe how you will mitigate this deficiency in the interim.
 
2.    You failed to prepare and follow a written Master Manufacturing Record (MMR) for each unique formulation of dietary supplement you manufacture, as required by 21 CFR 111.205(a). During the inspection, you informed our investigator that you do not receive a MMR from your contract manufacturer; however, since you package and label your own product, you are required to prepare and follow a written MMR for your packaging and labeling activities.
 
3.    You failed to prepare batch production records every time you manufactured a batch of dietary supplement products, as required by 21 CFR 111.255(a). Specifically, you had not generated any type of batch production records for the repacking of received bulk powder and encapsulated dietary supplement material into finished product containers in order to control and document each batch of dietary supplement products packaged and labeled, as required by 21 CFR 111.260.
 
We have reviewed your response letter, dated February 4, 2015, and have determined that your response is not adequate. Your response indicated that you will write production records to cover each batch of products to include: identity; weight; component identifier; label reconciliation; batch/lot numbers; maintenance details; and finished product quality. However, it is not clear your batch production records will include documentation, at the time of performance, of packaging and labeling operations, as required by 21 CFR 111.260(k). No example documentation was provided and you do not describe how you will mitigate this deficiency in the interim.
 
4.    You failed to establish and follow written procedures for fulfilling the requirements under 21 CFR 111.165 that apply to product received for packaging or labeling as a dietary supplement and for distribution to consumers, as required by 21 CFR 111.153.  Specifically, your firm receives bulk powders and encapsulated dietary supplement products for repacking and labeling; however, our investigator observed during the inspection that you have not established any written procedures for fulfilling the requirements of 21 CFR 111.165 that apply to products that you receive for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier).
 
We have reviewed your response letter, dated February 4, 2015, and have determined that your response is not adequate. Although you assured us you would log product receiving details as required, you do not describe what aspects of the received materials would be reviewed and logged, nor do you describe how you will visually examine received materials, as required by 21 CFR 111.165. In addition, you must make and keep records of documentation that the appropriate requirements of 21 CFR Part 111, Subpart G were met, as required by 21 CFR 111.180(b)(3). However, it is not clear from your response letter whether you will document the following: the initials of the person performing the required operation; the date the material was received; the results of any tests or examinations conducted; and any material review and disposition decisions. No example documentation was provided and you do not describe how you will mitigate this deficiency in the interim.
 
5.    You failed to quarantine received product and packaging until the product and packaging could be reviewed and approved by quality control personnel to release from quarantine, as required by 21 CFR 111.160(c) and 21 CFR 111.165(c). Specifically, you failed to quarantine received bulk powder and encapsulated dietary supplements materials, containers, and closures used to repackage dietary supplements into finished product containers. 
 
We have reviewed your response letter, dated February 4, 2015, and have determined that your response is not adequate. Although you promised that quarantine records would be established, you do not clarify whether the quarantine records will document that products were held in quarantine and restricted from use in your packaging and labeling operations until: a representative sample of each unique shipment and lot of received product was collected; quality control personnel reviewed and approved the documentation to determine whether the received product meets your firm’s established specifications; and quality control personnel reviewed and approved the received product for use in packaging and labeling operation. No example documentation was provided and you do not describe how you will mitigate this deficiency in the interim.
 
6.    You failed to clean and sanitize filling and packaging equipment as appropriate, as required by 21 CFR 111.415(a). Specifically, our investigator observed the packaging/counting machine, used to count and repack bulk encapsulated dietary supplement material into smaller finished product containers, contained various different colored capsules indicating that the machine had not been cleaned after previous runs. 
 
We have reviewed your response letter, dated February 4, 2015, but we are unable to evaluate the adequacy of your response. Although you promised to immediately begin appropriate cleaning measures after each run and record this in the appropriate manner, you did not describe specific steps that will be taken to ensure the quality and proper packaging and labeling of the dietary supplement.  No example documentation was provided and you do not describe how you will mitigate this deficiency in the interim.
 
7.    You failed to establish written procedures for maintaining, cleaning, and sanitizing equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required under 21 CFR 111.25(c). Specifically, you had not established the above mentioned procedures applicable to your re-packaging and labeling operations of received bulk powder and encapsulated dietary supplements into finished product container bottles and bags. 
 
We have reviewed your response letter, dated February 4, 2015, and have determined that your response is not adequate. Although you promised to immediately begin appropriate cleaning measures after each run and record this in the appropriate manner, your response does not indicate that you will establish written procedures to assure that cleaning will be performed adequately. Your response letter does not explain what aspects of the cleaning will be documented nor does it describe how the cleaning will be evaluated for acceptability. No example documentation was provided, and you do not describe how you will mitigate this deficiency in the interim.
 
8.     You failed to establish and follow written procedures for your packaging and labeling operations, as required under 21 CFR 111.403. Specifically, you had not established written procedures for your re-packaging and labeling operations of received bulk powder and encapsulated dietary supplements into finished product containers in accordance with 21 CFR 111.420.
 
We have reviewed your response letter, dated February 4, 2015, and have determined that your response is not adequate. Although you committed to write procedures for packaging and labeling as soon as possible, your response lacks sufficient detail for us to determine whether your written procedures will describe the controls for label printing, issuance, reconciliation, and destruction adequately to prevent labeling mix-ups. No example documentation was provided and you do not describe how you will mitigate this deficiency in the interim.
 
9.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required under 21 CFR 111.553. Specifically, you had not established written procedures to review and investigate product complaints for your products.
 
We have reviewed your response letter, dated February 4, 2015, and have determined that your response is not adequate. Although you committed to writing procedures for review and investigation of all product complaints as soon as possible, your response does not provide sufficient detail to determine the adequacy of your complaint management system. It is not clear that you will keep a written record of every product complaint that is related to a good manufacturing practice, as required under 21 CFR 111.570(b)(2), including the following information: the name and description of the dietary supplement; the batch, lot, or control number for the dietary supplement, if available; the date the complaint was received; the name, address, and phone number of the complainant, if available; the nature of the complaint including, if known, how the product was used; the reply to the complainant; findings of the investigation; and follow-up action taken when an investigation is performed. No example documentation was provided and you do not describe how you will mitigate this deficiency in the interim.
 
Misbranded Dietary Supplements
 
In addition, even if your NaturalDoctor Vitamins C & K3 / 100:1™; NaturalDoctor Organic Dong Quai Plus™; NaturalDoctor Organic Dandelion Plus™; and NaturalDoctor St. John’s Mood Plus™ products were not unapproved new drugs, these products would still be misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343], as would your NaturalDoctor Organic Peppermint Powder product based on the following violations of labeling requirements for dietary supplements:
 
1.    Your NaturalDoctor Vitamins C & K3 / 100:1™; NaturalDoctor Organic Dong Quai Plus™; NaturalDoctor Organic Dandelion Plus™; NaturalDoctor Organic Peppermint Powder; and NaturalDoctor St. John’s Mood Plus™ 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 products does not comply with 21 CFR 101.36.  Specifically:
  • All of the products listed above fail to present nutrition information on the nutrition label using the title “Supplement Facts” and enclosed in a box in accordance with 21 CFR 101.36(e).
  • The NaturalDoctor Vitamins C & K3 / 100:1™ product label fails to list the percent of the Daily Value of Vitamin C and calcium, in accordance with 101.36(b)(2)(iii).
  • The NaturalDoctor Organic Dong Quai Plus™; NaturalDoctor Organic Dandelion Plus™; and NaturalDoctor St. John’s Mood Plus™ product labels fail to list the quantitative amount by weight of each dietary ingredient in accordance with 101.36(b)(3)(ii), or to the extent these dietary ingredients are intended to be a proprietary blend of ingredients, the labels fail to meet the requirements in 21 CFR 101.36(c)(2), including identifying the ingredients by the term “Proprietary Blend” and the NaturalDoctor Organic Dandelion Plus™ product label fails to declare the quantitative amount by weight of the blend.
  • The NaturalDoctor Organic Peppermint Powder product labels fail to list the quantitative amount by weight of each dietary ingredient in accordance with 101.36(b)(3)(ii).
2.    Your NaturalDoctor Vitamins C & K3 / 100:1™; NaturalDoctor Organic Dong Quai Plus™; NaturalDoctor Organic Dandelion Plus™; NaturalDoctor Organic Peppermint Powder; and NaturalDoctor St. John’s Mood Plus™ products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] in that the serving size is not declared or the serving size declared on the labels is 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  101.12(b), Table 2. For example, the NaturalDoctor Vitamins C & K3/100:1™ product suggests the consumer take 3-9 capsules 3 to 4 times a day, but the nutrition information is for each capsule. The serving size listed should be 9 capsules.
 
3.    Your NaturalDoctor Organic Dong Quai Plus™ and NaturalDoctor St. John’s Mood Plus™ products are misbranded within the meaning of section 403(s)(2)(B) [21 U.S.C. § 343(s)(2)(B)] because the labels do not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
(b)(3)(B)
 
The above violations are not intended to be an all-inclusive statement of violations that exist in connection with your products and their labeling. 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 the Act 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.
 
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 15 working days of your 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 15 working days, state the reason for the delay and the time within which you will complete the action.
 
Your reply should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Maria P. Kelly-Doggett, Compliance Officer. If you have any questions regarding any issues in this letter, please contact Compliance Officer Maria Kelly-Doggett by telephone at 425-302-0427. 
 
Sincerely,
/S/ 
Miriam R. Burbach
District Director
 
 
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
 

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