Natural Products Services, Inc. 7/23/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
July 23, 2013
WL # 49-13
James G. Dina, Owner
Natural Products Services, Inc.
620 S. Andreasen Drive
Escondido, CA, 92029
Dear Mr. Dina:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 620 S. Andreasen Drive, Escondido, California from October 11-22, 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 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. You can find the Act and the referenced regulations through links in FDA's homepage at www.fda.gov.
In addition, FDA has reviewed your product labels for CircuForce™, HealthForce Liver Rescue 4+, HealthForce Scram, and HealthForce Nopal Blood Sugar and determined that the products are promoted for conditions that cause them 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 product labels 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.
Unapproved New Drugs
Examples of some of the claims on your product labels that provide evidence that your products are intended for used as drugs include:
- “Due to Ginkgo’s natural effect of increasing blood circulation*, let your doctor know if you are taking any pharmaceutical blood thinning medications, including aspirin, as your dosage may need to be monitored and/or altered.”
HealthForce Liver Rescue 4+:
- “Helps protect the skin from ultraviolet radiation”
- “Nutritionally Supports Anti-Microbe, Anti-Fungal … Anti-Bacterial…Functions”
- “SCRAM™ dietary supplement uses therapeutically effective quantities … to kill unwanted microorganisms.”
Healthforce Nopal Blood Sugar:
- “Caution to insulin users/diabetics: Due to Nopal’s natural effect of assisting the moderation of blood sugar and insulin levels, check with your doctor as your dose may need to be monitored/adjusted.”
Furthermore, your product HealthForce Nopal Blood Sugar 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 layman can use this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its 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)].
Adulterated Dietary Supplements
Even if your products did not contain disease claims in its labeling that cause them to be drugs, your dietary supplement products are adulterated based on the following significant violations of the dietary supplement CGMP requirements:
1. You did not conduct at least one appropriate test or examination to verify the identity of every component that is a dietary ingredient, to determine whether specifications are met [21 CFR 111.75(a)(l)(i)]. Specifically, you did not perform any identity testing for the dietary ingredients Milk Thistle Seed Extract, Dandelion Root Extract, Wasabi Japanica, and Picrorhiza Kurroa that were used to manufacture your HealthForce Nutritionals Liver Rescue 4+, lot numbers 12034, 12090, 12157, and 12216. Further, your firm has not requested or been granted approval for an exemption from this requirement.
We have reviewed your response letter, dated November 7, 2012. You state “NPS has implemented the clear establishment of specifications for dietary ingredients used in the manufacture of Dietary Supplement Products”. You further state “The development of these specifications is complete for current production and will be completed and implemented for all future dietary ingredients receipts and release”. While you provided a copy of a specification for (b)(4), the dietary ingredient used in your Truly Natural Vitamin C product and an identity test result for (b)(4), you did not include any other identity specifications and test results for other dietary ingredients that you used to manufacture the other dietary supplement products noted in the inspectional observations (Form 483) provided to you at the conclusion of FDA’s inspection.
2. You failed to establish the following specifications [21 CFR 111.70]:
- 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 the dietary supplement [21 CFR 111.70(e)], for your HealthForce Nutritionals Liver Rescue 4+, HealthForce Nutritionals CircuForce Brain Power, and HealthForce Nutritionals Truly Natural Vitamin C dietary supplement products.
- You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)].
- 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)].
We have reviewed your response letter, dated November 7, 2012, and have determined your response to be inadequate. You included a finished product specification for Truly Natural Vitamin C. You also state “These specifications are developed for current production and will be completed as additional production of different products becomes current.” However, in your response you also included a batch production record (BPR) for Truly Natural Vitamin C lot 12304 and an equipment cleaning log for (b)(4). Within the subject BPR a Label Use Log is included that identifies a number of other dietary supplement products produced from 10/31/12 – 11/06/12, dates subsequent to the inspection. The equipment cleaning log also identifies other dietary supplement products that have been produced during that time. You have not provided any finished product specifications for these other products you produced.
In your response you state “Specifications for components used in the manufacture of Dietary Supplements are established for those materials presently in use”. You refer to the Packaging Spec Sheet included in the response. The packaging spec sheet only includes specifications for the physical parameters of packaging materials such as dimensions, material, color and thread count. In addition, the specifications provided do not cover all components presently in use.
You also state “The specifications are in place for Dietary Supplement products either in or scheduled for production with completion of specifications performed prior to the issuance of additional orders for Dietary Supplements”. You refer to a Label Spec Sheet that was included in the response. The subject document does not include specifications for your packaging and labeling operations that ensure that you used the specified packaging and that you applied the specified label.
3. You did not prepare and follow a written master manufacturing record 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 [21 CFR 111.205(a)]. Specifically, you have not established a written manufacturing record for the dietary supplements that you manufacture [21 CFR 111.210].
During the inspection you created the document “Master Manufacturing Record – SOP” which identifies the dietary supplements that you manufacture and describes some general requirements for a master manufacturing record (MMR); however, you do not actually have MMRs for the dietary supplements included in the SOP.
4. Your firm’s batch production records (BPR) did not include complete information relating to the production and control of each batch and the requirements to be included in a batch record [21 CFR 111.255(b) and 111.260]. Specifically, your firm’s BPR for your Liver Rescue 4+ dietary supplements did not include the following required information:
- The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
- The date and time of the maintenance, cleaning, and sanitizing of equipment and processing lines used in producing the batch or a cross reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)].
- A statement of the actual yield and percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
- The results of any testing or examination performed during the batch production, or cross-reference to such results [21 CFR 111.260(h)].
- Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)].
- Documentation of the manufacture of the batch at the time of performance [21 CFR 111.260(j)].
o The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
o The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)]; and
o The initials of the person responsible for verifying the addition of components into a batch [21 CFR 111.260(j)(2)(iv)].
- Documentation at the time of performance of packaging and labeling operations [21 CFR 111.260(k)].
o The unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and reconciliation of any discrepancies between issuance and use of labels [21 CFR 111.260(k)(1)];
o An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2);
o The results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)(3)];
- Documentation at the time of performance that quality control personnel did the following, as required by 21 CFR 111.260(l).
o Review of any monitoring operations [21 CFR 111.260(l)(1)(i)];
o Review of the results of any tests and examinations, including tests and examination conducted on component in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements [21 CFR 111.260(l)(1)(ii)];
o Approved or rejected any reprocessing or repackaging [21 CFR 111.260(l)(2)]; and
o Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(4)].
- Documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)].
We have reviewed your response letter, dated November 7, 2012, and have determined your response to be inadequate. In your response you included a revised BPR for Truly Natural Vitamin C [Lot #12304]; however, the BPR you provided still lacks all the information required in 21 CFR 111.260.
5. You did not maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplements [21 CFR 111.27(d)]. Specifically, on 10/17/2012 your firm was observed manually re-packing/re-labeling HealthForce Nutritionals Truly Vitamin C [lot# 12291]. A brown-like and orange-like powder residue was observed on the bottling line, sifter, drums, and large totes containing components and in-process dietary supplements. According to your production manager the equipment was not cleaned from the previous production day in which you manufactured several other dietary supplements.
We have reviewed your response letter, dated November 7, 2012, and have determined your response to be inadequate. In your response you included new procedure # SOP-CEU, Cleaning of Equipment and Utensils, in which you describe the procedures for cleaning equipment used to manufacture dietary supplement products. You also included an Equipment Cleaning Log for (b)(4); however, you have not provided any evidence that you have fully implemented the new procedure. In addition, the new procedure section 22.214.171.124 states “Food contact surfaces are sanitized using isopropyl alcohol solution mixed at a concentration of 50% with water.” We note that cleaning compounds and sanitizing agents must be adequate for their intended use [21 CFR 111.27(d)(6)] and therefore you must ensure that diluted isopropyl alcohol is effective as a sanitizer.
6. You did not quarantine packaging and labels before you used them in the manufacture of a dietary supplement [21 CFR 111.160(c)]. Specifically, your firm did not quarantine packaging and labeling for a quality control review; involving collecting representative samples to conduct tests and examinations to ensure they meet specifications, and identifying each unique lot within each unique shipment of labels and packaging in a manner that allows traceability of the lot to the name of the labels, the status of the labels, and the finished dietary supplements that are distributed.
We have reviewed your response letter, dated November 7, 2012, and have determined your response to be inadequate. You included your new procedure #SOP-QR, Quarantine and Release; however, the SOP does not include specific procedures that ensure the packaging and labeling is quarantined until:
- You collect representative samples of each unique shipment, and of each unique lot within each unique shipment, of packaging and labels and, at a minimum, conduct a visual identification of the immediate containers and closures [21 CFR 111.160(c)(2)];
- Quality control personnel approve the results of any tests or examinations conducted on the packaging and labels [21 CFR 111.160(c)(2)]; and
- Quality control personnel approve the packaging and labels for use in the manufacture of a dietary supplement and release them from quarantine [21 CFR 111.160(c)(3)].
7. You did not make and keep records of the written procedures for manufacturing operations [21 CFR 111.375(b)]. You must also establish and follow written procedures for manufacturing operations [21 CFR 111.353]. Your firm has established procedures for how to use pieces of equipment such as (b)(4) however you have not established written procedures for manufacturing operations for your dietary supplements. Such records are required to ensure your dietary supplements are manufactured in a manner that ensures product specifications are consistently met.
We have reviewed your response letter, dated November 7, 2012, and have determined your response to be inadequate. You state “The use of the major pieces of equipment [in] the operations area is identified within the Batch Production Records for Dietary Supplement Products” and refer to the BPR for Truly Natural Vitamin C that you provided in your response as an example. The BPR identifies the equipment used in manufacturing the batch; however, it does not include the applicable manufacturing procedures.
Misbranded Dietary Supplements
Even if the labeling for your products did not contain claims that cause them to be drugs, they would still be misbranded dietary supplements under section 403 of the Act [21 U.S.C. § 343] in that the labeling does not comply with the food labeling requirements in 21 CFR § 101, as follows:
Your Truly Natural Vitamin C, CircuForce™,Liver Rescue 4+, HealthForce Scram™, and Nopal Blood Sugar™ products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that the product labels fail to declare the common or usual name of each ingredient. For example,
- Your CircuForce™, Liver Rescue 4+, HealthForce Scram™, HealthForce ZeoForce™ , and Nopal Blood Sugar™ products contain VeganCaps, but the labels fail to declare capsule ingredients in accordance with 21 CFR 101.4(g).
- Your Truly Natural Vitamin C, CircuForce™, Liver Rescue 4+, HealthForce Scram™, and Nopal Blood Sugar™ products list the term “ingredients” or “other ingredients” within the nutrition information label. The ingredient list on a dietary supplement should be located below or immediately contiguous and to the right of the nutrition label and preceded by the words “ingredients” unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 21 CFR 101.36(d), in which case the ingredients listed outside the nutrition label shall be in a list preceded by the words “Other ingredients” [21 CFR 101.4(g)].
- Your Truly Natural Vitamin C fails to list “Acerola Berry” in the nutrition information label. Further, the label states that Acerola Berry provides “co-factors including bioflavonoids, vitamins, minerals, and phytonutrients”, and therefore, acerola along with the part of the plant (berry) should be listed in the nutrition information of the label as a (b)(3) dietary ingredient.
Your Truly Natural Vitamin C, HealthForce Scram™ and Liver Rescue 4+ products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] because the label fails to bear nutrition labeling (“Supplement Facts” panel) in the proper format, which is required under 21 CFR 101.36. For example:
- Your Truly Natural Vitamin C product fails to list the quantitative amount by weight per serving for the Acerola Berry ingredient,
- Your HealthForce Scram™ product declares a serving size of only 1 VeganCap but the suggested usage states “Days 4-18: Ten Vegan Caps” to be taken “ideally, all at once”. The term serving size for a dietary supplement is the maximum amount as recommended on the label for consumption per eating occasion in accordance with 21 CFR 101.9(b) and 101.12(b) Table 2. Therefore, the serving size for HealthForce Scram™ should be 10 VeganCaps.
- Liver Rescue 4+ declares a serving size of 2 but states that 2-4 VeganCaps should be consumed “in two divided servings or taken all at once”. Therefore, the serving size as per the label is 4, the maximum amount of VeganCaps to be consumed in one eating occasion.
Your CircuForce™ and Liver Rescue 4+ products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. 343(s)(2)(C)] because the label fails to indicate the part of the plant from which some of the dietary ingredients are derived in accordance with 21 CFR 101.4(h)(1). For example,
- CircuForce™ fails to declare the part of the plant from which Ginkgo Biiloba and Siberian Eleuthero and Gotu Kola are derived.
- Liver Rescue 4+ fails to include the part of the plant from which Picrorhiza is derived.
Your HealthFirce ZeoForce and HealthForce Nopal Blood Sugar products are misbranded under Section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] 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 Nopal Blood Sugar™ and HealthForce ZeoForce™ products are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] because the labels fail to declare the name and place of business of the manufacturer, packer, or distributor, in accordance with 21 CFR 101.5.
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 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)). 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.
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
Please send your reply to the Food and Drug Administration, Attention:
Blake Bevill, Director
Los Angeles District
Irvine, CA, 92612-2506
If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 619-941-3769.
Alonza E. Cruse, Director
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, California 95899-7435