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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

DC Nutrition, Inc. 2/4/13

  

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 

 

February 04, 2013
 
WARNING LETTER
 
 
VIA UPS Overnight Mail
 
 
Stephen Horgan, President/CEO
DC Nutrition, Inc.
9500 West 49th Avenue
Suite D-106
Wheatridge, CO  80033
 
Ref: # DEN-13-06-WL
 
Dear Mr. Horgan:
 
On June 26 – 28, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 9500 West 49th Avenue, Wheatridge, Colorado.  The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) 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). 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 the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. In addition, our investigators collected and reviewed samples of the labeling of your Functional Water System products during the inspection of your facility and from your website, including a recent visit to your homepage at http://www.hardnutrition.com in January 2013. Based on our review of the labeling of your products, FDA has concluded that your products are in violation of section 403, 505(a) and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)] and the regulations implementing the requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101) and Part 111 (21 CFR Part 111). You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.  
 
The significant violations identified by FDA include, but are not limited to, the following:
 
Adulterated Dietary Supplements
 
1)      You failed to implement a system of production and process controls which covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.55. Specifically, you have not implemented a system of production and process controls for the responsibilities of the quality control operations, including establishing and approving specifications, establishing controls for the receipt, quarantine, and testing of raw material, establishing controls for the processing of your raw material such as mixing or blend times, or theoretical weights of (b)(4) encapsulations of your products. 
 
We have reviewed your response dated July 19, 2012 and determined it to be inadequate. You stated you have “corrected the batch control sheet, “chang[ed] the mixing sheets to add a counter check of weight for each ingredient,” and added a review of blending and encapsulating at each stage. You also indicated you are in the process of (b)(4), but still used a signed copy of the Certificate of Analysis (COA) on each purchase of raw material from your suppliers to certify purity and potency and provide the lab testing results for them. You also indicated you are developing release criteria and will complete written procedures within the next (b)(4). Your response did not include any documentation, including the batch control sheets, master manufacturing records, testing records to show the changes you made to them in establishing a production and process controls system and to allow FDA to evaluate these changes. Further, the timeframe to complete written procedures is unacceptable. You did not give a reason why it would take (b)(4) to complete written procedures. Please be advised that you must qualify your suppliers’ COAs before you can rely on them.  
 
This is a repeat observation from the August 30 though September 9, 2011 inspection that FDA conducted of your facility.
 
2)      Your firm failed to establish product specifications for the identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of your finished dietary supplements, as required by 21 CFR 111.70(e).  Specifically, during the inspection, you told our investigators that your firm has not established finished product specifications for any of your dietary supplement products. 
 
Further, your firm failed to verify that your finished dietary supplements met product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished dietary supplements, as required by 21 CFR 111.75(c).  
 
Some examples of your batch production records for the following released finished dietary supplement products lacked finished product testing to verify that they met finished product specifications for identity, purity, strength, and composition are as follows:
 
  • Amino Acid, (b)(4)
  • Grain Ease, (b)(4)
  • Oxy Extreme, (b)(4)
  • B Replacement, (b)(4)
  • Hangover, (b)(4)
  • Thermo Blast, (b)(4)
  • Hoodia Plus, (b)(4)
  • Sugar Curb, (b)(4)
  • Digestive Enzymes, (b)(4)
  • Focus, (b)(4)
  • Mega Green, (b)(4)
  • Vita Charge, (b)(4)
  • Extended Energy Vitamins, (b)(4) 
 
We have reviewed your response dated July 19, 2012 and determined it to be inadequate. You stated that your corrected batch control sheet, corrected formula sheet, and the addition of a (b)(4) will meet this requirement. However, you did not provide any of these records for our review to show that you established finished product specifications. In addition, you stated you will continue to use COAs to verify product integrity. Please clarify your use of a COA to meet your requirements that the dietary supplements are verified to meet product specifications. Further, your timeframes to establish written product specifications and testing of finished products of (b)(4) is unacceptable. 
 
This is a repeat observation from the August 30 though September 9, 2011 inspection that FDA conducted of your facility.
  
3)      Your firm’s master manufacturing records (MMR) for the dietary supplements Hoodia Plus Product (b)(4), Thermo Blast Product (b)(4), Oxy Extreme Product (b)(4), Mega Green Product (b)(4), and Extend Energy Vitamins Product (b)(4) failed to identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in your MMR, as required by 21 CFR 111.205(b)(1). Your firm’s MMRs for these products failed to establish controls and procedures to ensure that each batch of dietary supplements that you manufacture meets the specifications identified, as required by 21 CFR 111.205(b)(2). Your firm’s MMRs for these dietary supplement products failed to include the following information required by 21 CFR 111.210:
 
  • A complete list of components to be used, as required by 21 CFR 111.210(b). For example, the capsule ingredients for these products were not listed;
  • The identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label, as required by 21 CFR 111.210(d);
  • A statement of any intentional overage amount of a dietary ingredient as required by 21 CFR 111.210(e);
  • A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made, as required by 21 CFR 111.210(f);
  • A description of packaging and 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);
  • Written instructions, including specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.210(h)(1);
  • Procedures for sampling in the MMRs, as required by 21 CFR 111.210(h)(2);
  • Written instructions, including specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR 111.210(h)(3)].
  • Written instructions for your manual operations, as follows:
o   one person to add and another person to verify the addition of the components, as required by 21 CFR 111.210(h)(3)(ii)(A);
o   one person adding the component and another person verifying the addition, as required by 21 CFR 111.210(h)(3)(ii)(B).
  • The written instructions in your master manufacturing records did not include corrective action plans to use when a specification is not met, as required by 21 CFR 111.210(h)(5). 
 
We have reviewed your response dated July 19, 2012 and determined it to be inadequate. Your response promises corrections to your batch records with very little details. In addition, your response does not indicate what changes will be made to correct the deficiencies in your master manufacturing records, as the observation indicates. Further, your timeframe to implement the proposed changes to your manufacturing records of (b)(4) is unacceptable. 
 
This is a repeat observation from the August 30 though September 9, 2011 inspection that FDA conducted of your facility.
 
4)      Your firm’s batch production records (BPR) did not include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 111.260. Specifically, your firm’s BPRs did not include the following required information:
 
a.  The identity of the equipment and processing lines used in producing the batch, as required by 21 CFR 111.260(b). For example, the identity of the equipment used to blend and mix the components was not listed in your BPRs.
 
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, as required by 21 CFR 111.260(c). 
 
c.  A statement of the actual yield and percentage of theoretical yield at appropriate   phases of processing, as required by 21 CFR 111.260(f). For example, the actual and theoretical yields after the blending and encapsulation operations were not listed in your BPRs.
 
d.  The actual results obtained during any monitoring operation, as required by 21 CFR 111.260(g).
 
e.  The results of any testing or examination performed during the batch production, or a cross-reference to such results, as required by 21 CFR 111.260(h). 
 
f.  Documentation that the finished dietary supplement meets specifications established in accordance with § 111.70(e) and (g), as required by 21 CFR 111.260(i).
 
g.  Documentation of the manufacture of the batch at the time of performance, as required by 21 CFR 111.260(j).  Specifically, the following information was not documented in your BPRs at the time of performance:
 
i.  The date on which each step of the MMR was performed [21 CFR 111.260(j)(1)]. For example, the mixing, screening and encapsulating steps listed in the MMR were not documented in the BPR;
 
ii.  The initials of the person responsible for weighing or measuring of each component used in a batch [21 CFR 111.260(j)(2)(i)];
 
iii.  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)];
 
iv.  The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)]; and
 
v.  The initials of the person responsible for verifying the addition of components into a batch [21 CFR 111.260(j)(2)(iv)].
 
h.  Documentation, at the time of performance, of packaging and labeling operations, as required by 21 CFR 111.260(k), including (1) 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)]; and (2) 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)].
 
i.    Documentation at the time of performance that quality control reviewed the BPR, including any monitoring operation and the results of any tests and examinations on the finished batches of dietary supplements, and approved and released the batch and the packaged and labeled dietary supplements [21 CFR 111.260(l)]. 
 
j.    Documentation at the time of performance of any required material review and disposition decision, as required by 21 CFR 111.260(m). For example, your batch control record for the product “Sugar-Less” documents the weight requested in the mixing stage as (b)(4) and the final weight as (b)(4). No material review or disposition decision was documented for this deviation.
 
We have reviewed your response dated July 19, 2012 and determined it to be inadequate. You indicated you will implement changes to your BPRs in the next (b)(4). However, this timeframe is unacceptable. 
 
This is a repeat observation from the August 30 though September 9, 2011 inspection that FDA conducted of your facility.
 
5)      Your firm failed to establish identity specifications for each component that you use in the manufacture of your dietary supplement products, and failed to establish component specifications as necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, for each component that you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b).  Specifically, during the inspection, you told our investigators that your firm has not established any specifications for the components that your firm uses in the manufacture of your dietary supplement products. 
 
Further, your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). You indicated to our investigator that organoleptic testing is performed on some raw materials. However, organoleptic testing is inadequate for distinguishing the identity of powders with similar organoleptic properties. Therefore, this testing is not appropriate to verify the identity of a component that is a dietary ingredient.
 
Instead, you indicated in your written response dated July 19, 20012 that your firm relied on certificates of analysis (COAs) from your suppliers for individual dietary ingredients and going forward you asked all of your vendors to furnish additional lab reports to verify the identity of each ingredient used. A COA from a supplier may not be used to verify the identity of any component that is a dietary ingredient (see 21 CFR 111.75(a)(2) for requirements for components that are not dietary ingredients).
 
Further, your firm failed to qualify the suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, before using those components, as required by 21 CFR 111.75(a)(2)(ii)(A), and failed to maintain documentation of how the supplier was qualified, as required by 21 CFR 111.75(a)(2)(ii)(C).  Under 21 CFR 111.75(a)(2), a certificate of analysis may be relied upon to confirm the identity of a component that is not a dietary ingredient and to determine whether applicable component specifications established in accordance with 21 CFR 111.70(b) are met.  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) 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) maintain documentation of how the supplier was qualified; (D) periodically re-confirm the supplier’s certificate of analysis; and (E) the documentation setting forth the basis for qualification (and re-qualification) of any supplier must be reviewed and approved by quality control personnel.  Specifically, we reviewed the certificate of analysis for flax seed powder (b)(4), provided by your supplier.  Your firm failed to qualify the supplier by establishing the reliability of the certificate of analysis through confirmation of the results of the supplier’s tests or examinations. 
 
We have reviewed your response dated July 19, 2012 and determined it to be inadequate. Your response did not address whether you will establish component specifications and you did not provide documentation how you will qualify your suppliers. You also indicated that vendor qualification program will be implemented in (b)(4). This timeframe for implementation is inadequate. 
 
6)      You failed to establish 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. Our investigator found that you had no written procedures for your firm’s quality control operations. 
 
Further, your firm’s quality control operations for the master manufacturing records and the batch production records failed to include reviewing and approving all master manufacturing records and all modifications to the master manufacturing records as well as reviewing and approving all batch production-related records, as required by 21 CFR 111.123(a)(1) and (2). 
 
Further, your firm failed to have quality control operations for components, packaging, and labels before use in the manufacture of a dietary supplement, as required by 111.120. Specifically, you failed to have quality control operations for determining whether all components, packaging and labels conform to components, packaging and label specifications [21 CFR 111.120(b)]; and approving and releasing from quarantine all components, packaging and labels before they are used [21 CFR 111.120(e)].  
 
We have reviewed your response dated July 19, 2012 and determined it to be inadequate.  You did not provide any documentation to support your proposed corrections. Further, you indicated that these corrections will be implemented (b)(4). This timeframe for implementation is inadequate. 
 
Unapproved New Drugs
 
We have determined through review of labeling on your website, www.hardnutrition.com, that the products “Cleanz+,” “Fix It” and “Get Over It -- Feel Better Now”, 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 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. The marketing of these products with these claims violates the Act. 
 
Examples of some of the claims observed on your website include:
 
Cleanz+
 
“What should you expect from using Cleanz +?
  • Fewer headaches
  • Reduced aches and pains”
 
Fix It
 
  • “Fix it joint recovery.”
  • “Fix-It is the only total joint repair system…”
  • “G.C.M….Helps repair damaged joint and cartilage”
  • “Fix it helps reduce inflammation, ease tendonitis and break down mineral deposits that cause pain in the joints…”
  • “Helps deliver pain free movement”
  • “Helps reduce Tendonitis and repetitive motion damage”
 
Get Over It – Feel Better Now
 
  • “Headache Relief – No more pain”
  • “Anti-inflammatory: helps revive brain functions”
  • “Works great on hangovers too!”
  • “Absorbs toxins that can cause headaches pain”
 
The unlawful disease treatment and prevention claims observed for these and other products on your websites are too numerous to mention in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
 
Your products “Fix It,” “Cleanz+” and “Get Over It--Feel Better Now”, are not generally recognized as safe and effective for the above referenced uses and therefore, the products are also “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. Your products “Fix It” and “Get Over It – Feel Better Now” are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that labeling for these drugs fail to bear adequate directions for use.
 
Misbranded Dietary Supplements
 
In addition, if your products, including those listed above, were not labeled for conditions that cause them to be unapproved new drugs, these products would be misbranded dietary supplements. Specifically, your products “Get Over It--Feel Better Now”, “ “Renew!”, “Cleanz+”, “Fat Fighter”, “Perform!”, “Rebuild!”, “Think!”, Whacked”, and “Health Plus,” are misbranded dietary supplements within the meaning of sections of 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B) and 21 CFR § 343(i)(1)], in that the labels fail to identify the products 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 ingredients in the products.
 
Your products “Get Over It--Feel Better Now”, “Renew!”, “Cleanz+”, “Fat Fighter”, “Perform!”, “Rebuild!”, “Think!”, Whacked”, and “Health Plus” are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)], in that the labels fail to bear a declaration of the net quantity of contents on the principal display panel of the dietary supplement capsules in accordance with 21 CFR 101.105.
 
Your products “Fat Fighter”, “Perform!”, “Rebuild!”, “Think!”, and Whacked” 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 fail to identify the part of the plant from which each botanical dietary ingredient in the products are derived in accordance with 21 CFR 101.4(h)(1). For example, the label for “Fat Fighter” fails to list the part of astragalus used as a dietary ingredient. The label for “Perform!” fails to list the part of Suma used for the extract. The label for “Rebuild!” fails to list the part of guggul used. The labels for “Think!” and “Whacked” fail to list the part of gotu kola used.
 
Your products “Get Over It”, “Renew!”, “Cleanz Plus”, “Fat Fighter”, “Perform!”, “Rebuild!”, “Think!”, Whacked”, and “Health Plus” are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(f)(F)], in that the nutrition information on the labels do not comply with 21 CFR 101.36. Specifically, the labels do not bear the title “Supplement Facts” under 21 CFR 101.36(e)(1). Furthermore, the labels do not segregate the 21 CFR 101.36(b)(2) and (b)(3) dietary ingredients into separate sections of the supplement facts panel in accordance with 21 CFR 101.36(b)(3)(i), and the ordering of (b)(2)-dietary ingredients within the supplement facts panel is not in accordance with 21 CFR 101.36(b)(2)(i)(B).
 
Furthermore, you do not list the total quantitative amount by weight of all your other dietary ingredients contained in each of your proprietary blends for your products “Cleanz Plus, “Fat Fighter”, and “Get Over It” as required by 21 CFR 101.36(c)(3). In addition, the quantitative weights for your dietary ingredients amylase, protease, cellulose, lactase, lipase, invertase, and glucoamylase in “Fat Fighter” and “Cleanz Plus” are not listed with metric unit measures in accordance with 21 CFR 101.36(b)(3)(ii)(A). Furthermore, you do not list the term “Proprietary Blend” or other appropriately descriptive term or fanciful name for your blend. For example, the label for “Get Over It” lists Energy Boost Cleanse and “Renew!” lists Ach-Away in place of “Proprietary Blend”. The dietary ingredients within each blend are also not indented under each blend name in accordance with 21 CFR 101.36(c)(2).
 
Your products “Whacked” and “Rebuild!” are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] and in accordance with 21 CFR 101.36(b)(2) (B) and 101.9(c)(8)(iv), and 21 CFR 101.36(b)(3), respectively. For example, you do not list the common or usual name “niacin” on your “Whacked” label but rather the source ingredient inositol hexaniacinate. Furthermore, the label for “Rebuild!” lists “Kre-Alkalyn”, which is not the common or usual name for this dietary ingredient.
 
Your products “Think!”, and “Get Over It” are misbranded within the meaning of section 403(s)(2)(A) of the Act [21 U.S.C. § 343(s)(2)(A)], in that the labels fail to list the quantity of each dietary ingredient and the total quantity of all ingredients in the blend in accordance with 21 CFR 101.36(b)(2) and (b)(3).   For example, your “Think!” label lists several botanical dietary ingredients after Iodine without individual quantitative weights per serving or a total weight of the proprietary blend. 
 
The labeling for your products “Get Over It--Feel Better Now”, “Health Plus”, and “Think!” is misleading within the meaning of section 201(n) of the Act [21 U.S.C. § 321(n)] because these products contain iron for use as an iron source but fail to bear the warning statement for dietary supplement in solid oral dosage form (e.g., tablets or capsules) required in accordance with 21 CFR 101.17(e).  Therefore, these products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because their labeling is misleading.
 
(b)(4)
 
The above violations are not intended to be an all-inclusive list of violations in your facility or with your products. It is your responsibility to ensure that your facility and all of your products are in compliance with all requirements of the Act and implementing regulations. 
 
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
 
We have the following additional comments:
 
  • For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the samples using the same container closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)]. Further, the reserve samples must be identified with the appropriate batch or lot number for at least one (1) year past the shelf life date (if shelf life dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with a reserve sample [21 CFR 111.83((b)(2)-(3)].
  • You failed to provide hand washing facilities which are designed to ensure an employee's hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities which are adequate, convenient, and furnish running water at a suitable temperature [21 CFR 111.15(i)]. Your response of installing a sink for hand washing in the next (b)(4) is inadequate. 
  • The information panels of your labels for the products “Think!”, “Get Over It”, “Rebuild!”, “Cleanz Plus”, and “Health Plus” contain intervening material as defined in 21 CFR 101.2(e), which states that all information appearing on the information panel pursuant to this section shall appear in one place without other intervening material. The phrase “In an herbal base of:” is intervening material within the information panel for your product “Think!”. The label for your product “Rebuild!” contains the phrase “Registered (Buffered Creatine US Patent #6,399,661)” after the term “Kre-Alkalyn”, and is also another example of intervening material in the information panel for this product.
 
We request you notify this office in writing within 15 working days from your receipt of this letter of your corrective actions and the specific steps you have taken to correct the noted violations. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by 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 re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)).
 
Your written response should be directed to the U.S. Food and Drug Administration, Attention: Nancy G. Schmidt, Compliance Officer, at the above address. If you have questions about this letter, please contact Ms. Schmidt at (303) 236-3046.
 
Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director