| Public Health Service Food and Drug Administration |
Seattle District |
Department of Health and Human ServicesVIA OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
November 10, 2011
In reply refer to Warning Letter SEA 12-04
Mr. Kartar S. Khalsa, CEO
Golden Temple of Oregon, LLC
121 SW Morrison Street, Suite 925
Portland, Oregon 97204
WARNING LETTER
Dear Mr. Khalsa:
On May 16-19, 2011, the U.S. Food and Drug Administration (FDA) inspected your facility, located at 950 International Way, Springfield, Oregon. Because you label your products as dietary supplements, we evaluated whether the products were prepared, packed, and held under conditions that comply with FDA's Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). During the inspection, our investigators found significant violations of the CGMP regulations for dietary supplements. 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 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 reviewed your website at the Internet address http://www.yogitea.com, which auto-directs to http://www.yogiproducts.com, in November 2011. Our review of your website determined that your "Joint Comfort" and "Breathe Deep" products are promoted 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 website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
Dietary Supplement CGMP Violations
The inspection revealed the following significant violations of the CGMP regulations for dietary supplements:
1. The written instructions in your Master Manufacturing Records (MMR) for every product that you manufacture, including your Egyptian Licorice INT lot #0055673 and Egyptian Licorice 6-Pack lot #0055672, lack the following information that is required by 21 CFR 111.210(h).
• Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement.
• Procedures for sampling and a cross-reference to procedures for tests or examinations.
• Corrective action plans for use when a specification is not met.
We acknowledge your June 1, 2011, response to the FDA 483. However, your response did not provide sufficient information for FDA to evaluate the adequacy of your proposed corrective action for Observations 1, 3, and 4, which discuss the violations referenced above. While you have outlined what you plan to do to correct the violations, you have not provided any documentation to show that you have made the necessary corrections.
2. Your firm's MMRs for every product that you manufacture, including the Egyptian Licorice 6-Pack (lot #0055672), did not include a representative label, or a cross-reference to the physical location of the actual or representative label, as required by 21 CFR 111.210(g).
We acknowledge your June 1, 2011, response. However, your proposed corrective action for Observation 2 is not adequate. Your response indicates that you plan to add a statement "to the record" to direct the (b)(4) operator to retrieve the label, prior to starting he packing/assembly run, but this does not address the violation because it does not ensure that a label is actually attached to the MMR or that the MMR references the physical location of the label.
3. Your batch production records for every product do not include documentation that quality control personnel reviewed the results of any tests and examinations, as required by 21 CFR 111.260(1)(1)(ii). For example, batch production records for your Egyptian Licorice 6-Pack (lot #0055672) and Egyptian Licorice INT (lot#0055673) supplements do not include documentation that quality control personnel reviewed the results of tests or examination of any in-processing or finished product at the time of performance.
We acknowledge your June 1, 2011, response. However, your response did not provide sufficient information for FDA to evaluate the adequacy of your proposed corrective action to Observation 7. While your response outlined your plans to correct the violation, you did not provide any documentation, such as an updated batch production record, to show that you have made the correction.
4. Your batch production record for your Egyptian Licorice (lot #0055673) did not include a statement of percentage of theoretical yield at appropriate phases of processing, as required by 21 CFR 111.260(f). Specifically, the batch production record for your Egyptian Licorice INT (lot #0055673) did not include a calculation of percentage of theoretical yield at the in-batch processing stage.
We acknowledge your June 1, 2011, response. However, your response did not provide sufficient information for FDA to evaluate the adequacy of your proposed corrective action to Observation 9. While your response outlined your plans to correct the violation, you did not provide any documentation to show that you have made the correction.
5. You failed to hold components under conditions that will avoid mix-ups as required by 21 CFR 111.155(e). Specifically, we observed boxes of components in the storage area and blending room that did not have quarantine or release status labels.
We acknowledge your June 1, 2011, response. However, your proposed corrective action for Observation 10 is not adequate because you did not explain how you plan to reconcile your reliance on a (b)(4) database versus the need to have a physical identifier to track components and quality control status in real-time as the components are accessed and handled throughout your production process.
Unapproved New Drugs
Your "Joint Comfort" and "Breathe Deep" products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act. The following claims that promote these products as drugs were observed on your website:
Turmeric, Your Medicine Cabinet in a Curry Bowl
• "Recent scientific research is showing that turmeric [an ingredient in your Joint Comfort product] ... looks like the most potent remedy ever tested against Alzheimer's disease."
• The main active constituent, curcumin, the pigment that gives turmeric its distinctive yellow color, has profound anti-inflammatory effects for inflammatory skin disease (eczema, acne)."
• "Turmeric is extensively used as medicine in Ayurveda, and to a lesser extent in Traditional Chinese Medicine, where it is used to treat everything from indigestion to toothache."
• "Turmeric zaps a wide variety of infectious bugs. Ayurveda recommends it as an antibacterial for chronically weak or ill folks."
• "Turmeric reduces blood cholesterol .... "
• "Turmeric reduces blood cholesterol .... "
Your website also contains disease claims in the form of personal testimonials, including:
Breathe Deep
• "I have chronic asthma, which has been a bear lately and nothing else aside from stimulants or nasty chemicals has helped. I grabbed this tea last night in desperation, not having had much big success with other teas for lungs or breathing but this opened me up within about 15 minutes and I slept like a baby! I am stunned by the difference, from one cup of tea.''
• "I got this tea to try because I have asthma and have had it for years. I had been using an albuterol inhaler every day and sometimes more than once. Since I started drinking this tea daily I have only used the inhaler one time in the past 3 months."
• "From my experience, Breathe Deep tea is Clearly beneficial in assisting prevention of cold related symptoms."
• "This tea relieves my asthma for a few hours so that I can delay using my inhaler."
Your "Joint Comfort" and "Breathe Deep" products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 section 505(a) of the Act [21 U.S.C. § 355(a)]. 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.
The above violations are not meant to be an all-inclusive list of violations within your facility. It is your responsibility to ensure that all of your products are in compliance with all of the requirements of the Act and FDA regulations. We may take further action if you do not promptly correct these violations. For instance, we may initiate regulatory action without further notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operation.
In addition, we note that your labels currently bear your previous firm address in Eugene, Oregon. Your labels should bear your current place of business which is Springfield, Oregon.
Please notify this office, in writing, within fifteen (15) working days of receiving this letter, of the steps you have taken to correct the violations in this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and then the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating the corrections have been made.
Please send your reply to the Food and Drug Administration, Attn: Heidi Marks, Compliance Officer, at the above letterhead address. If you have any questions regarding issues in this letter, please contact Heidi Marks at 426-483-4862 or heidi.marks@fda.hhs.gov.
Sincerely,
/S/
Charles M. Breen
District Director
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