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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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NatureAll-STF Holding, LLC 1/31/14

  

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

Public Health Service
Food and Drug Administration
 Denver District Office
Building 20- Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
TELEPHONE: 303-236-3000 

 

January 31, 2014
 
WARNING LETTER
 
 
VIA UPS Overnight
 
Mr. Rockland N. Draper, Owner
NatureAll-STF Holding, LLC
DBA: Spinal Touch Formulas
34 W Louise Ave.
Salt Lake City, UT 84115
 
Ref: # DEN-14-04-WL
 
Dear Mr. Draper:
 
Between May 30 and June 6, 2013, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 34 W Louise Ave., Salt Lake City, UT.  The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation (CGMP regulation), Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).  Additionally, during the inspection our investigators collected for our review, the labels associated with many of your products. In December 2013, FDA also reviewed labeling on your website at the Internet address http://www.spinaltouchformulas.com.  Based on this review, we determined that you take orders there for Colostrum, Valerian-Plus, Wormwood, Black Walnut-Plus, Lung-Plus, Yucca-Plus, MSM Plus, White Willow Plus, Thymus-Plus Capsules, and Myrrh products which the website promotes 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 therapeutic claims on your website establish that the 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. 
 
Even if your Colostrum, Valerian-Plus, Wormwood, Black Walnut-Plus, Lung-Plus, Yucca-Plus, MSM Plus, White Willow Plus, Thymus-Plus Capsules, and Myrrh products were not unapproved new drugs, your violations of 21 CFR Part 111 cause these products and your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
 
In addition, even if your Black Walnut Plus and Myrrh products were not unapproved new drugs, as explained further below, they would be misbranded dietary supplements within the meaning of section 403 [21 U.S.C. § 343] of the Act, and its implementing regulations in 21 CFR Part 101. Furthermore, your Iron Plus and Prostate Plus dietary supplement products are misbranded within the meaning of section 403 and 21 CFR Part 101.  You may find the Act and FDA’s implementing regulations through links on FDA’s home page at www.fda.gov.
 
Unapproved New Drugs
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs include:
 
Colostrum
  • “May help fight off viruses, bacteria, toxins, and parasites”
  • “Many refer to colostrum as ‘Mother Nature’s’ most powerful natural antibiotic!”
 
Valerian-Plus
  • “Valerian Root [an ingredient in your product] use is most popular in Europe for … insomnia …”
 
Wormwood
  • “Anti-inflammatory, vermifuge …”
 
Black Walnut-Plus
  • “An all-natural parasite cleanse.  May help body eliminate worms and other parasites.”
  • “A special formulation of vermifugal ingredients”
  • “For use in parasite purging”
 
Yucca-Plus (Arthro-Plus)
  • “Arthritic Support”
 
White Willow Plus
  • “Nutritional Support for natural pain relief …”
 
MSM-Plus
  • “May provide pain relief for some individuals who have minor arthritis pain. May help with allergies.”
 
Myrrh
  • “skin sores, antiseptic, inflammation”
 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Lung-Plus and Thymus-Plus Capsules for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
  • “I have had a mild case of asthma all of my life.  I do not like to use inhalers or antihistamines because of the side effects.  My wife encouraged me to try your product, Lung-Plus.  It keeps my lungs clear and the condition is improving.”
  • “Thymus-Plus has alleviated muscle pain … and allergy symptoms…”
 
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 products Valerian-Plus, Lung-Plus, and Yucca-Plus 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 uses. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their 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)].
 
Dietary Supplement Violations
 
Our inspection of your facility revealed the following significant violations of the CGMP and label requirements for dietary supplements.
   
Dietary Supplements CGMP Violations
 
1.   You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient before using the component, as required by 21 CFR 111.75(a)(1)(i). Specifically, you did not conduct identity testing on the dietary ingredients Myrrh Gum Powder (batch number (b)(4)) and Wormwood (Artemisia annua) (lot number SB12-H071566C) that were used in the manufacture of your dietary supplements.
 
Moreover, during the inspection, your firm acknowledged to our investigator that NatureAll does not conduct any tests or examinations to verify the identity of incoming dietary ingredients. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you have petitioned FDA for an exemption from such testing, consistent with the requirements in 21 CFR 111.75(a)(1)(ii), and FDA has granted such petition.  Your firm has not petitioned FDA for such an exemption.
 
We have reviewed your response letter dated June 17, 2013 and determined it to be inadequate. Although your response states you will “[e]stablish and implement a plan to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use,” you did not include any documentation of such a plan.  Furthermore, you have not committed to any timeframes for implementing this correction.  
 
2.    You failed to verify that your finished batches of dietary supplements meet product specifications for identity, purity, strength, composition 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 111.75(c). You may verify that these specifications are met by testing or examining, (1) every finished batch, or (2) a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. If you test a subset of finished batches, you must identify the subset using a sound statistical sampling plan [21 CFR 111.75(c)]. Our investigators found that with respect to all of the products that you manufacture, you failed to conduct any type of finished product testing for identity, purity, strength, composition or limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch.
 
We have reviewed your response dated June 17, 2013 and determined it to be inadequate. In your response, you state that you will “[e]stablish and implement a plan to conduct appropriate tests or examinations, such as microbiological, heavy metal, pesticide, or other appropriate tests to assess the identity, purity, strength, composition, or contamination of manufactured batches of dietary supplements.” However, you did not include any documentation of your plan. Nor did you include any details of your plan, including proposed testing methods, frequency, acceptance criteria, possible analytical capabilities, or who may be qualified or responsible for reviewing the results. Further, your response did not set forth a date by which you will implement your plan. 
 
3.    You failed to establish written procedures for the responsibilities of your quality control operations, as required by 21 CFR 111.103. Specifically, your firm informed our investigators that you have not established quality control procedures. Please note that Subpart F of 21 CFR Part 111 sets forth requirements relating to your firm’s quality control operations.
 
We have reviewed your response dated June 17, 2013 and determined it to be inadequate. Although your response states that you will “[e]stablish and implement written procedures for quality control operations,” you failed to include any documentation of your plans to implement such procedures.  Furthermore, you have not committed to any timeframes for establishing and implementing written procedures for quality control operations. 
 
4.    You did not 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, your firm informed our investigators that you did not have MMRs for any of the dietary supplement products you manufacture. We note that an MMR must include the information specified in 21 CFR 111.210.
 
We have reviewed your response dated June 17, 2013 and determined it to be inadequate. Your response states that you will “[p]repare a written master manufacturing record for each unique formulation of a dietary supplement that [you] manufacture.” However, you did not include any documentation of MMRs or other information specifying what your MMRs will provide. Furthermore, you have not committed to any timeframes for preparing and following MMRs. 
 
5.    Your batch production records (BPRs) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260. Specifically, the BPRs that you provided to our investigators for Prostate-Plus Lot# 22401112, Yucca Plus Lot# 21601012 and Thyroid-Plus Lots: 2460021, 26100513, and 19800812 failed to include the following required information:
  • The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)].  Specifically, the identity of the equipment used to blend and mix components was not listed in your BPRs;
  • The unique identifier that you assigned to each component [21 CFR 111.260(d)]. Specifically, the BPRs for Thyroid-Plus Lots 2460021, 26100513, and 19800812 and for Yucca Plus Lot 21601012 contain a listing for “all 12 cell salts,” but do not provide unique identifiers for each of these 12 components;
  • The weight or measure of each component used [21 CFR 111.260(e)]. Specifically, the BPRs for Thyroid-Plus Lots 2460021, 26100513, and 19800812 and for Yucca Plus Lot 21601012 do not include the weight or measure for individual cell salts;
  • Documentation, at the time of performance, of the manufacture of the batch, as required by 21 CFR 111.260(j), including:
o   The initials of the person responsible for weighing or measuring each component used in a batch [21 CFR 111.260(j)(2)(i)];
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 to the batch [21 CFR 111.260(j)(2)(iv)].
  • An actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR [21 CFR 111.260(k)(2)].
 
We have reviewed your response dated June 17, 2013 and determined it to be inadequate. Although your response states that you will “[e]stablish and implement a plan to include complete information relating to the production and control of each batch,” you did not include any documentation of this proposed correction.  Furthermore, you have not committed to any timeframes for complying with the BPR requirements.
 
6.    You did not calibrate instruments you use in manufacturing or testing a component or dietary supplement, as required by 21 CFR 111.27(b). Specifically, your (b)(4) digital scale, which is used to weigh the filled capsules, had not been calibrated since November 7, 2002. In addition, your (b)(4) scale did not contain a sticker to indicate when the last calibration was conducted. Please note that you must calibrate before first use and either at the frequency specified in writing by the manufacturer of the instrument, or at routine intervals or as otherwise necessary to ensure the accuracy and precision of the instrument [21 CFR 111.27(b)].  Please also note that you must establish and follow written procedures for calibrating instruments that you use in manufacturing or testing a component or dietary supplement [21 CFR 111.25(a)], and that you must make and keep records of those written procedures [21 CFR 111.35(b)(1)(i)].  Furthermore, you must make and keep records documenting any calibration, each time the calibration is performed, for instruments that you use in manufacturing or testing a component or dietary supplement, in keeping with the requirements listed in 21 CFR 111.35(b)(3).
 
We have reviewed your response letter, dated June 17, 2013 and have determined your response to be inadequate. In your written response, you state that you will “[e]stablish and implement a plan to follow written procedures for calibrating instruments and controls that we use in manufacturing, specifically the (b)(4) scale and (b)(4) scale.” Your response did not include documentation of your planned calibration procedures. You also did not provide a timeframe for implementation of your corrective actions.
 
Misbranding Violations
 
7.    Your Iron Plus, Black Walnut Plus, Myrrh and Prostate-Plus products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels of the dietary supplements fail to identify the products by using the term “dietary supplement” as a part of the statement of identity in accordance with 21 CFR 101.3.
 
8.    Your Iron Plus, Black Walnut Plus, Myrrh and Prostate-Plus products 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 labels of the dietary supplements fail to identify parts of plants from which some of the botanical dietary ingredients are derived, in accordance with 21 CFR 101.36(d)(1). For example, your Iron Plus label fails to identify the part of the plant from which Echinacea purpurea is derived. Your Myrrh label fails to declare the part of the plant from which myrrh is derived.
 
9.    Your Iron Plus, Black Walnut Plus, Myrrh and Prostate-Plus products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. §343(y)] in that the labels do not include a current domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplements. 
 
10.    Your Iron Plus and Prostate-Plus products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)]. Specifically:
 
    • Your Prostate-Plus is manufactured as a capsule, but the labels fail to list the capsule ingredients in accordance with 21 CFR 101.4;
    • Your Iron Plus makes a claim to contain Calcium Phosphate, Calcium Sulphate, Sodium Phosphate, and Sodium Chloride in the “Mineral Salts Blend”, but it fails to list “Calcium”, “Sodium”, and “Chloride” and their total quantitative amounts by weight per serving, in accordance with 21 CFR 101.36(b)(2);
    • Your Prostate-Plus makes a claim to contain Calcium Phosphate, Ferric Phosphate, and Sodium Sulphate, in the “Mineral Salts Blend”, but it fails to list “Iron”, “Calcium”, and “Sodium” and their total quantitative amounts by weight per serving, in accordance with 21 CFR 101.36(b)(2).
11.    Your “Prostate-Plus” product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the label declares, and the product contains, Ferric Phosphate, a source of iron, but it fails to declare the warning statement for dietary supplements containing iron salts in accordance with 21 CFR 101.17(e).
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. 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 federal law 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 but not limited to seizure and/or injunction. 
 
In addition to the above violations, we have the following comments:
 
1.    During the inspection, your firm informed our investigators that you have not verified information from suppliers’ certificates of analyses. Under 21 CFR 111.75(a)(2), before you use a component that is not a dietary ingredient, you are required to confirm the identity of the component and determine whether other applicable component specifications are met.  To do so, you must either (1) conduct appropriate tests or examinations, or (2) rely on a certificate of analysis from the supplier of the component that you receive.  In order to rely on a certificate of analysis from a supplier of the component, the following requirements of 21 CFR 111.75(a)(2)(ii) must be met: (A) you must 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 examinations; (B) the certificate of analysis must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) you must maintain documentation of how you qualified the supplier; (D) you must periodically re-confirm the supplier’s certificate of analysis; and (E) your quality control personnel must review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.
 
2.    During the inspection, your firm informed our investigators that some records may have been discarded. Under 21 CFR 111.605 and 111.610, you must keep written records required by 21 CFR Part 111 and have such records, or copies of those records, readily available during the retention period for inspection and copying by FDA when requested. Your firm must keep written records required under 21 CFR Part 111 for one year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements associated with those records, as required by 21 CFR 111.605.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation.  If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections.
 
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.
 
Your written response should be directed to the U.S. Food and Drug Administration, Attention: Matthew R. Dionne, Pharm.D., Compliance Officer, at the above address. If you have questions about this letter, please contact Dr. Dionne at (303) 236-3065.
           
 
Sincerely,
/S/
LaTonya M. Mitchell
District Director
Denver District Office