Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm359315.htm
Timestamp: 2019-04-25 07:56:50+00:00

Document:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 29323 NW County Road 241, Alachua, Florida from September 24 - 28th, 2012. FDA also reviewed the labeling of your products, including your Internet website at http://www.herbsoflight.com, in April 2013. Based on our review of the labeling for your Agrimony, Blood Root, Brown Seaweed, Deer Tick Defense, Echinacea, False Unicorn, Goldenseal, Himalayan Crystal Salts Capsules, Holy Basil, Kidney/Bladder Blend, Lobelia, Mandrake, Olive Leaf, Moringa Botanical Multi-Vitamin, Resistant Microbes, Smoke Out, Thuja, Veins Assist, Vitex, White Oak Bark, Yarrow and Yeast Away products, we have determined that these products are promoted for conditions that cause the products to be 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)]. The claims made in the labeling for these products establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease of the human body. The marketing of these products with these claims violates the Act.
You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
“Himalayan Crystal Salts, in conjunction with enough water, is actually essential for the regulation of your blood pressure”.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” as defined by section 201(p) of the Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the United States 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.
Furthermore, because your Agrimony, Brown Seaweed, Deer Tick Defense, False Unicorn, Goldenseal, Himalayan Crystal Salts Capsules, Holy Basil, Kidney/Bladder Blend, Olive Leaf, Moringa Botanical Multi-Vitamin, Resistant Microbes, Thuja, Vitex, White Oak Bark, Yarrow and Yeast Away products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended uses. Thus, your product labeling fails to bear adequate directions for the products’ intended uses, causing these products to be misbranded under section 502(f)(1) of the Act [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)].
Even if your products did not have these therapeutic claims, which make them drugs, your products are 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 Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
Specifically, during our inspection, our investigators observed the following violations, which were noted on form FDA 483, Inspectional Observations, issued to you on September 28, 2012. We received your written response dated October 10, 2012 to the Form FDA 483. As discussed in more detail below, we find your response inadequate in that you failed to address the serious observations which were presented to you during the inspection of your facility and you failed to provide any documentation that indicates you have begun an effective corrective action plan to bring your firm into compliance with 21 CFR Part 111. You also have not addressed products you have manufactured, marketed, and distributed into commerce without CGMPs in place and which are therefore adulterated under the Act.
Your response to the FDA 483, dated May 31, 2013, was not reviewed however it may be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.
You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements including specifications that ensure that you used the specified packaging and that you applied the specified label [21 CFR 111.70(g)].
In your response letter dated October 10, 2012, you agree with the observation, and included a statement about the firm’s plans to "document established specifications" without providing details of the actual steps to be taken to correct this violation. Consequently, we could not evaluate the adequacy of your proposed corrections.
2. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you did not prepare a MMR for your Agrimony, Himalayan Crystal Salts Capsules, Black Willow, and Bloodroot dietary supplement products. In addition, you verbally confirmed to our investigator that your firm does not have written MMRs for your products.
In your response letter, dated October 10, 2012, you state that you agree with the observation, and included your intention to complete a written master manufacturing record for your best selling products by the last week of December 2012 and for all of your products by March 2013. However, you have not provided a copy of any written master manufacturing records for your products and therefore we can’t evaluate the adequacy of your corrective action.
Documentation at the time of performance of any reprocessing [21 CFR 111.260(n)].
You state in your response dated October 10, 2012, that you agree with the observation and that you will include all the required information in your batch records by the last week of October 2012. However, you have not provided a copy of any updated batch records to date and therefore we can’t evaluate the adequacy of your corrective action.
4. You stated during the inspection that you confirm the identify of components that are not dietary ingredients by relying on a certificate of analysis from the supplier of each component, as set forth in 21 CFR 111.75(a)(2)(ii). However, you failed to first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier’s tests or examination, as required by 21 CFR 111.75(a)(2)(ii)(A) and you failed to make and keep documents of your qualification of a supplier for the purpose of relying on the supplier's certificate of analysis, as required by 21 CFR 111.95(b)(2). Specifically, you did not provide any information regarding the qualification of your suppliers. You stated at the time of inspection that you only order from reputable manufacturers. However, without additional information, this is not sufficient to meet the requirements of 21 CFR 111.75(a)(2).
In your October 10, 2012 response you address this deviation by stating that you have developed a written procedure by which “herbal components received without C.O.A.s to be put into quarantine until the C.O.A is received” and implemented this effective October 8, 2012. This response is inadequate because it does not address how you will qualify the supplier by establishing the reliability of the supplier’s C.O.A., as required by 21 CFR 111.75(a)(2)(ii)(A), how you will maintain documentation of how you qualified the supplier, as required by 21 CFR 111.75(a)(2)(ii)(C), and that you will make and keep records regarding documentation of your qualification of a supplier, as required by 21 CFR 111.95(b)(2).
Pressing herbs during liquid extraction.
Without written procedures, there is no assurance that the dietary supplement products are consistently manufactured to meet specifications. Once you establish and follow your written procedures, you are also required to make and keep records of your written procedures for manufacturing operations as required by 21 CFR 111.375(b).
We have reviewed your response dated October 10, 2012, indicating your intent to create a written procedure for all manufacturing operations involved in the production of your dietary supplements by the 2nd week of February 2013. However, you have not provided any documentation of written procedures that you have developed and therefore we can’t evaluate the adequacy of your corrective action.
You did not have records to demonstrate that you quarantine components before you use them in the manufacture of a dietary supplement until you collect a representative sample of each unique lot of components (and, for components the you receive, of each unique shipment, and of each unique lot within each unique shipment) [21 CFR 111.155(c)(1)].
Retaining reserve samples for 1 year past the shelf life date (if shelf life dating is used), or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve samples, for use in appropriate investigations [21 CFR 111.465(b)].
We have reviewed your response dated October 10, 2012 and determined that it is inadequate. You state in your response that you agree with the observation and that you are "establishing a written procedure for the holding inventory and for distributing operations, effective the 4th week of November 2012.” However, you have not provided any documentation of your written procedure for the holding inventory and for distributing operations and therefore we can’t evaluate the adequacy of your corrective action.
8. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distributed as required by 21 CFR 111.83(a). Specifically, our investigator did not observe any samples of any lots of packaged and labeled dietary supplements that you had collected or held reserve.
We have reviewed your response dated October 10, 2012 and determined that it is inadequate. You state in your response that you agree with the observation and that you “have begun an initial process for the collection of reserve samples, and will have a process of documenting the reserve of samples for all batches (which will be in the consistent packaging as the product), effective week of October 8, 2012.” However, you have not provided any evidence or other documentation to demonstrate that you have implemented a process to collect and hold reserve samples and therefore we can’t evaluate the adequacy of your corrective action.
9. 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you have not established written procedures for your quality control operations and you verbally confirmed this during our investigation.
We have reviewed your response dated October 10, 2012 and determined that it is inadequate. You state in your response that you agree with the observation and that you “will have a written Quality Control procedure completed by the 4th week of January 2013.” However, you have not provided us any documentation of your written quality control procedures and, therefore, we can’t evaluate the adequacy of your corrective action.
10. You failed to make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of 21 CFR 111.15(e)(2), as required by 21 CFR 111.23(c). You also failed to use water that complies with applicable Federal, State, and local requirements for uses such that the water may become a component of a dietary supplement, as required by 111.15(e)(2).
a. You have not established written procedures detailing the testing process and the frequency of testing of the water used as a component of finished batches of dietary supplement products.
b. Your water, originating from two on-site wells, that may become a component of finished batches of dietary supplement products (through contact with any contact surface), was last tested for compliance with applicable Federal, State, and local requirements in October 2012. Additionally, water from the two on-site wells is filtered through a water energizer/distillation machine, prior to being used as a component of finished batches of liquid dietary supplement products, such as single herb and multiple herb blended liquid extracts. Water filtered through this aforementioned machine has not been tested following filtration for compliance with Federal, State, and local requirements for water safety.
We have reviewed your response dated October 10, 2012 and determined that it is inadequate. You state in your response that you will establish a written procedure detailing the water testing process and frequency according to Federal, State, and local requirements by the third week in October, 2012. However, you did not provide any documentation of your written procedure or other evidence that you are complying with the requirements of 21 CFR 111.15(e)(2). Therefore, we cannot evaluate the adequacy of your corrective actions.
11. You did not establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.303. You also did not make and keep records to provide documentation that the laboratory methodology is followed, including the results of the testing and examination, as required by 21 CFR 111.325(b)(2)(ii). Specifically, your firm performs in-process acceptance testing (for proper color, residue, and transparency) but does not have established written procedures or documentation for this testing or its corresponding results.
We have reviewed your response dated October 10, 2012 and determined that it is inadequate. You state in your response that you agree with the observation and that you “are establishing written procedures for laboratory operations including implementation for organoleptic testing” by the 2nd week of February, 2013. However, you have not provided any documentation of your written procedures for laboratory operations and, therefore, we cannot evaluate the adequacy of your corrective actions.
12. You failed to establish and follow written procedures for handling product complaints as required by 21 CFR 111.553. Specifically, you must establish and follow procedures providing that a qualified person review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications or any other requirements that, if not met, may result in a risk of illness or injury [21 CFR 111.560(a)(l)].
We reviewed your October 10, 2012 dated response and determined that it is inadequate. You stated in your response that you agree with the observation and have provided a template to document customer complaints. However, your template does not address how a decision will be made to determine whether the complaint involves a possible failure of a dietary supplement to meet any of its specifications.
Determining the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution [21 CFR 111.410(d)].
In addition, you failed to make and keep records of the written procedures for packaging and labeling operations as required by 21 CFR 111.430(b).
We have reviewed your response dated October 10, 2012, indicating your intent to create written procedures detailing your firm’s operations when packaging and labeling your dietary supplements by the 4th week of November 2012. However, your response is inadequate because you did not provide any supporting documentation of your corrective action.
14. You failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, you did not have written procedures for handling any returned dietary supplements, including when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520, or when a returned dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515.
We have reviewed your response dated October 10, 2012 and determined that it is inadequate. You stated in your response that you agree with the observation and that you are “establishing a written procedure for what to do when a returned herbal supplement is returned,” and that the written procedures will be completed and you will begin to implement them by the 2nd week of November 2012. However, you have not provided a copy of your written procedures for returned dietary supplements and, therefore, we cannot evaluate the adequacy of your corrective action.
Further, even if your products listed below did not have the therapeutic claims referenced above, which make them drugs, they are misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343] and its implementing regulations in 21 CFR Part 101, as discussed further below.
1. Your Agrimony, Alfalfa, Angelica, Bitter Melon, Black Willow, Bladderwrack, Blood Root, Blue Cohosh, Broccoli Defense, Cat’s Claw, Chaparral, Cleavers, Damiana, Dandelion Root, Devil’s Club, Dong Quai, Goat’s Rue, Graviola, Green Tea, Guggul, Hawthorn, Himalayan Crystal Salts Capsules, Holy Basil, Khella, MaiReiShiitake Mushroom, Maitake Mushroom, Marshmallow, Mistletoe, Moringa Botanical Multi-Vitamin, Ovary / Uterus, Poke Root, Reishi Mushroom, Resistant Microbes, Shiitake Mushrooms, Stevia, Turmeric, and Venus Fly Trap labels are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. 343(y)] in that the labels fail to include a complete domestic address or domestic phone number through which the responsible person (as described in section 761(b)) may receive a report of a serious adverse event with such dietary supplement.
2. Your Agrimony, Alfalfa, Angelica, Bitter Melon, Black Willow, Bladderwrack, Blood Root, Blue Cohosh, Broccoli Defense, Cat’s Claw, Chaparral, Cleavers, Damiana, Dandelion Root, Devil’s Club, Dong Quai, Goat’s Rue, Graviola, Green Tea, Guggul, Hawthorn, Himalayan Crystal Salts Capsules, Holy Basil, Khella, MaiReiShiitake Mushroom, Maitake Mushroom, Marshmallow, Mistletoe, Moringa Botanical Multi-Vitamin, Ovary / Uterus, Poke Root, Reishi Mushroom, Resistant Microbes, Shiitake Mushrooms, Stevia, Turmeric, and Venus Fly Trap product labels are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] because the label fails to list the place of business of the manufacturer, packer, or distributor as required by 21 CFR 101.5(a) and (d). The labels in use at the time of the inspection only list the name of the business and the firm’s website www.herbsoflight.com.
3. Your Alfalfa, Bladderwrack, Blue Cohosh, Cat’s Claw, Dandelion Root, Green Tea, Hawthorn, Himalayan Crystal Salts Capsules, Holy Basil, Marshmallow, Moringa, Ovary/Uterus, Resistant Microbes, Turmeric and Venus Fly Trap product labels are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the dietary ingredients are contained in capsules, but the capsule ingredients are not listed on the label in accordance with 21 CFR 101.4(g).
4. Your Agrimony, Alfalfa, Angelica, Bitter Melon, Black Willow, Bladderwrack, Blood Root, Blue Cohosh, Broccoli Defense, Cat’s Claw, Chaparral, Cleavers, Damiana, Dandelion Root, Devil’s Club, Dong Quai, Goat’s Rue, Graviola, Green Tea, Guggul, Hawthorn, Himalayan Crystal Salts Capsules, Holy Basil, Khella, MaiReiShiitake Mushroom, Maitake Mushroom, Marshmallow, Mistletoe, Ovary / Uterus, Poke Root, Reishi Mushroom, Resistant Microbes, Shiitake Mushrooms, Stevia, Turmeric, and Venus Fly Trap product labels are misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] because they fail to bear nutrition information (“Supplement Facts” panel) in accordance with 21 CFR 101.36.
5. Your Agrimony, Alfalfa, Cleavers, MaiReiShiitake Mushroom, Maitake Mushroom, Mistletoe, Moringa Botanical Multi-Vitamin, Ovary / Uterus, Reishi Mushroom, Resistant Microbes, and Shiitake Mushrooms product labels are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the label fails to identify the part of the plant from which one or more of the botanical dietary ingredients in the product are derived, as required by 21 CFR 101.4(h)(1). For example, your Reishi Mushroom label fails to identify the part of the mushroom used (e.g., mycelium, stalk, cap, or whole mushroom).
This letter is not intended to be an all-inclusive list of violations which exist in connection with your products. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in enforcement action, without further notice, including, without limitation, seizure and/or injunction.
21 CFR 111.25 requires that you establish and follow written procedures for fulfilling the requirements for equipment and utensils. However, we did not identify written procedures for (a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement; (b) Calibrating, inspecting and checking automated, mechanical and electronic equipment; or (c) Maintaining, cleaning and sanitizing, as necessary, all equipment, utensils and other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements.
21 CFR 111.14(b)(1) requires that you make and keep written procedures for determining personnel qualifications requirements. However, we did not identify written procedures for verifying that all employees involved in the operations of your firm such as manufacturing, packaging, labeling, or holding or in performing any quality control operations are qualified by education, training, or experience to perform their assigned functions to comply with 21 CFR 111.12(c).
Further, 21 CFR 111.14(b)(2) requires that you make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained. However, we did not identify such documentation. . Specifically, you were unable to provide any documentation to indicate that you have performed training of your personnel. Our investigator was informed by the Office Manager, that when hired, employees are trained via on-the-job training, then rotated through the different stages of the manufacturing process and further cross-trained in all aspects of the manufacturing process over their term of employment.
In your response letter dated October 10, 2012, you provided a brief SOP for “Qualifying Employees” with the intent to provide written “Employee Training Operations” by the 2nd week of December 2012. You also stated in your letter that you would be sharing with the agency an “Employee Training Video” as soon as available, which at present has not been received. However, you failed to provide any documentation or other evidence demonstrating that this training program has been implemented. Consequently, we are not able to evaluate your corrective action at this time and will verify your procedures and documentation of training at the next scheduled inspection of your firm.
During the inspection you indicated to the FDA investigator that you were unaware of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, effective 12/22/07, or Section 761 of the FD&C Act, which contains the reporting requirement for adverse events. Under section 761 (c) of the Act, you must submit a report of a serious adverse event no later than 15 business days after the report is received through the address or phone number described in section 403(y) of the Act. Because prompt submission of serious adverse event reports is important for public health reasons, we recommend that all serious adverse event reports be reported to FDA within 15 business days of receipt (regardless of the means by which you receive the initial report). More information on adverse event reporting can be found online in the publication "Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act," revised in June 2009, available on our website, www.fda.gov.
Some of the firm’s products labeled as dietary supplements are not intended for ingestion, and are therefore not consistent with the statutory definition of a dietary supplement (Section 20l(ff)(2)(A)(i) of the Act). Hence such products do not qualify as dietary supplements. For example, "Eyesight Blend", labeled as a dietary supplement, is an ophthalmic solution (i.e., not "intended for ingestion") and therefore does not qualify as a dietary supplement. Another example is "Himalayan Crystal Salts", which has a bath detoxification regimen included with other instructions in the brochure, but the bottle of capsules labels the product as a dietary supplement.
We suggest that you have data to support the "expiration dates" established in your firm’s finished product specifications and applied to your firm’s finished dietary supplement products, including Moringa Botanical Multi-Vitamin which is labeled with an expiration date of 9/04/2022 (see 72 FR 34752 at 34856; June 25, 2007).
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 determining 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 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 reinspection-related costs from the responsible party for the domestic facility.
Please respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations noted above and the steps you are taken to prevent their recurrence. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete these corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Please send your written reply to the Food and Drug Administration, Attention: Ms. Carla Norris, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have questions regarding any issues in this letter, please contact Ms. Norris at (407) 475-4730.

References: § 321
 § 321
 § 355
 § 352
 § 331
 § 342
 § 343
 § 343
 § 379
 § 379