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WARNING LETTER

Nutritional Engineering Inc MARCS-CMS 527965 —

Recipient:
Recipient Name
Mr. Theodore L. Laoudis
Nutritional Engineering Inc

1208 Avenida Chelsea
Vista, CA 92083-8315
United States

Issuing Office:
San Francisco District Office

United States

 

  

Black HHS-Blue FDA Logo

 

Division of Human and Animal
Food Operations West 5
19701 Fairchild Irvine, CA 92612-2506 

 
 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
9/29/17         
                                                                                                                                   WL #527965-17
Mr. Theodore L. Laoudis, President
Nutritional Engineering Inc.
1208 Avenida Chelsea
Vista, CA 92083-8315
 
Dear Mr. Laoudis:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Nutritional Engineering Inc., located at 1208 Avenida Chelsea Vista, CA 92083-8315, on 4/11-13, 19-20, 5/2-3/2017. The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products: (b)(4), (b)(4), (b)(4), (b)(4), and (b)(4), 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 CGMP requirements for dietary supplements.  Additionally, based on our review of the labels for your “(b)(4),” “(b)(4),” and “(b)(4)” products, we have determined that these products are misbranded under section 403 of the Act [21 U.S.C. 343].
 
You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.
 
We have received your written response dated 5/19/17, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on 5/3/17. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
 
The significant violations documented during the inspection include, but are not limited to, the following:
 
Dietary Supplement CGMP Violations
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements:
 
1.    You failed to establish an identity specification for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, you did not establish identity specifications for components used in the manufacture of your products (b)(4)], (b)(4), (b)(4), (b)(4), and (b)(4).
 
 We acknowledge your response dated May 19, 2017, which states you have established a (b)(4)% match as a standard for all FTIR testing. You did not provide documentation regarding the quality control unit review and approval of this specification for identity testing, as required by 21 CFR 101.105(a) and as a laboratory control process, as required by 21 CFR 111.110(a) and if it is applicable to all ingredients such as minerals, vitamins, and botanicals. We note that you are required to establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for establishing appropriate specifications in accordance with 21 CFR 111.315(a).
 
2.    You 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 you qualified the supplier; (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. For example, we reviewed the certificate of analysis for the components, including Phosphoric Acid 75%, Glycerine 99.7%, Zinc Gluconate, Glucosamine HCl, TriCalcium Phosphate N2 Powder, Manganese Gluconate, Methylsulfonyl Methane (MSM), Chondroitin Sulfate, Xylitol, and Vitamin B-5 (D-Calcium Pantothenate) provided by your supplier. Your quality control personnel approved these ingredients for use and released them after only comparing the results of the assay analysis from your supplier with the firm’s written specifications. 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 May 19, 2017, and determined it to be inadequate. Your response does not address your failure to reject the lots that failed to meet your specifications. In addition, your response, dated July 28, 2017, only provided testing results and did not provide further evidence of adequate corrective actions regarding the failures noted above. For example, documentation to show the qualification of the supplier’s COAs was not included.  
 
3.    You failed to verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), that your finished batch of the dietary supplement meets product specifications, as required by 21 CFR 111.75(c). For example:
  • (b)(4)., Lot (b)(4), was not tested for Arsenic, Cadmium, Lead, Mercury, Vitamin A, and Proprietary Herbal Blend;
  • (b)(4), Lot (b)(4), and (b)(4). Lot (b)(4), were not tested for Salmonella, Staph. Aureus, Arsenic, Cadmium, Lead, Mercury, and twenty-three dietary ingredients;
  • (b)(4), Lot (b)(4), was not tested for Vitamin C (Ascorbic Acid), Graviola Leaf Powder, and Moringa Leaf Powder;
  • (b)(4), Lot (b)(4), (b)(4) Lot (b)(4), was not tested for Salmonella, Staphylococcus aureus, Arsenic, Cadmium, Lead, Mercury, and forty-five dietary ingredients. 
We have reviewed your response, dated May 19, 2017, and determined it to be inadequate. Your response states you will retroactively retest (b)(4), Lot (b)(4), (b)(4), Lot (b)(4), (b)(4), Lot (b)(4), and (b)(4), Lot (b)(4). Retroactively testing a quality control released and distributed finished dietary supplement is not an adequate corrective action. Your response also includes Standard Operating Procedure, Testing and Disposition of Raw Materials and Finished Product, Document #: 05-16, Revision Number 05, Effective Date 5/12/17. This procedure does not provide an explanation as to the scientific rationale behind the sampling and testing methods described to provide that all finished dietary supplement products will meet established specifications.
 
4.    Your firm did not ensure that the tests or examinations you use to determine that you have met the established specifications are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically, you use Fourier Transform infrared spectroscopy (FT-IR) for all identity testing; however, your standard reference material is inappropriate because it is a previous lot of product for which identity has not been confirmed. A previous lot is not an acceptable standard unless it is adequately confirmed to be acceptable as a reference standard using scientifically valid methods.  You must establish and follow laboratory control processes that are reviewed and approved by quality control personnel, for use of criteria for selecting standard reference materials used in performing tests and examinations, as required by 21 CFR 111.315(d). Specifically, you use the previous lot or same lot of raw materials received as the standard for subsequent incoming shipments. However, you failed to establish any criteria to establish a reference standard. And, you failed to demonstrate that the non‐compendia standards originating from these lots were thoroughly characterized to ensure their identity, purity, quality, and strength. Non‐compendia reference standard materials should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength. Once characterized, the official qualification documentation of these standards must be reviewed and approved by Quality Control prior to use, as required by 21 CFR 111.110(a).
 
For example:
  • Chamomile, lot # (b)(4), was analyzed and released after using a previously received lot, lot # (b)(4), from your supplier in 2006.
  • Vitamin D3 100,00 IU, lot # (b)(4), was analyzed and released after using a previously received lot, lot # (b)(4), from your supplier in 2006.
  • Potassium Citrate Monohydrate, lot # (b)(4), was analyzed and released using a lot, lot # (b)(4), received from your supplier.
  • Methyl Sulfonyl Methane (MSM), lot # (b)(4), was analyzed and released after using a previously received lot, lot # (b)(4), from your supplier in 2006.
  • Phosphoric Acid 75%, lot 3’s (b)(4), (b)(4), and (b)(4) were analyzed and released after using a previously received lot, lot # (b)(4), from your supplier in 2006. 
You also tested the same lot of incoming components against itself to determine component identity. For example:
  • Licorice Root 20% Lot (b)(4), was tested against itself on April 22, 2016.
  • Graviola Leaf Powder Lot (b)(4), was tested against itself on February 25, 2017.
We have reviewed your response, dated May 19, 2017, and determined it to be inadequate. Your response states you have established a (b)(4)% match as a standard for all FT-IR testing. Your response also states you will use Thin Layer Chromatography (TLC) testing results from a third-party lab as well as the third-party FT-IR testing of components already present at your firm to use as reference standards. FT-IR testing should be performed using qualified reference standards. Additionally, your May 19, 2017 response, states that you purchase some USP Standards for vitamins and minerals and will send botanicals to contract lab for TLC testing to create your own library to the FTIR. Non-compendia reference standard materials should be of the highest purity by reasonable effort and should be thoroughly characterized to ensure their identity, purity, quality, and strength. Once characterized, the official qualification documentation of these standards must be reviewed and approved by Quality Control prior to use. You have not provided related documentation in your response.
 
5.    Your firm's MMR 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 MMR for these dietary supplement products, failed to include the following information required by 21 CFR 111.210:
  • 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).
Specifically, the MMRs for (b)(4), (b)(4), (b)(4), (b)(4), and (b)(4) contain steps indicating that an in-process step of pasteurization may be required. However, this step in these products’ MMRs does not provide written instructions on how the decision to pasteurize is determined.
 
We have reviewed your response, dated May 19, 2017, and determined it to be inadequate. There are no instructions or cross references to requiring the pasteurization of an ingredient in this form. The documents provided in your response continue to have multiple choices for pasteurization temperature as well as no record of how the decision on whether to pasteurize the product was made.
 
6.    Your batch production records (BPRs) failed to accurately follow the appropriate master manufacturing record (MMR) and you did not perform each step in the appropriate MMR/BPR on the production of each batch, as required by 21 CFR 111.255(c). Specifically,
  • The Batch Production Record (BPR) for (b)(4), Lot number (b)(4), states at (b)(4) to “(b)(4)” but mixing was documented to have occurred between “(b)(4)” and “(b)(4)” on March 8, 2017.
  • The BPR for Antioxidant Blend #(b)(4), states at (b)(4) to “(b)(4)” but the (b)(4) record within this BPR documents the temperature as (b)(4) degrees (°) Fahrenheit (F).
In addition, the BPR’s for (b)(4)., Lot # (b)(4), (b)(4)., Lot#(b)(4), and [(b)(4)., Lot# (b)(4), did not include the actual results which were obtained during the monitoring of operations, as required by 21 CFR 111.260(g). The BPR for (b)(4), Lot # (b)(4), at (b)(4), and the BPR for (b)(4), Lot# (b)(4), at (b)(4), does not provide for the documentation of the actual temperature or a cross reference to where the actual temperature recorded was documented. The BPR for (b)(4), Lot# (b)(4), at (b)(4), states to “(b)(4)”. A chart recorder was not attached to this BPR. The “(b)(4)” form section of all the referenced BPRs to document this temperature does not provide for the actual temperature to be recorded and documented.
 
We have reviewed your response, dated May 19, 2017, and determined it to be inadequate. Your response provides training records which state your BPRs have been revised but copies of the revised BPRs were not included for review.
 
7.    You failed to 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. Specifically, your firm did not have a written procedure for creating the reference standards for the Fourier Transform infrared spectroscopy (FT-IR) testing your firm performs.
 
We have reviewed your response, dated May 19, 2017, and determined it to be inadequate. The procedure included in your response, “How to Create Specifications and Reference Standards, Document #: 05-019, Revision Number 01, Effective Date 5/12/17,” references the procedure “Standard Operation Procedure 05-012 FTIR” but your response did not include the referenced procedure for review.
 
8.    When a dietary supplement failed to meet an established specification, your quality control personnel did not reject the component or dietary supplement, nor did they approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in your master manufacturing record (MMR), as required by 21 CFR 111.77(a) and 111.113(b)(2); nor did your firm’s quality control personnel conduct a material review and make a disposition decision when the established specification was not met, as required by 21 CFR 111.113(a)(1).
 
Specifically, out of specification results were received for component Phosphoric Acid 75%, Lot Number (b)(4), (b)(4), (b)(4) and finished product, (b)(4), Lot Numbers (b)(4), (b)(4), and (b)(4), tested by your laboratory personnel. Instead of rejecting the component, you used them in the manufacture of the finished dietary supplement product. Your quality control unit failed to reject Phosphoric Acid 75%, which were released and used in the manufacturing of a finished product or reject the finished product, (b)(4), which was released for distribution.
 
We have reviewed your response, dated May 19, 2017, and determined it to be inadequate. Your response states you will retroactively retest one of the lots of Phosphoric Acid 75% addressed above. Retroactively testing a quality control released and distributed finished dietary supplement is not an adequate corrective action.
 
Misbranding Violations
 
We reviewed the labeling of your “(b)(4)” “(b)(4)” and “(b)(4)” products and determined that these products are misbranded under section 403 of the Act [21 U.S.C. 343] for the reasons described below.
 
1.    The “(b)(4)” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36, 101.4 and 101.22(j). For example:
  • The product label declares (b)(4), (b)(4), and (b)(4), but these are not the common or usual names for ingredients.
  • The product declares “preservatives” in the list of ingredients. A food to which a chemical preservative(s) is added must, except when exempt pursuant to 101.100, bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function in accordance with 21 CFR 101.22(j).
2.    The “(b)(4)” and “(b)(4)” products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the labels are incorrect and not expressed in a common household measure that expresses the serving size of the food. Specifically:
  • The “(b)(4)” label’s serving size is not expressed in a common household measure. The directions of use suggest the consumer take a “maximum dose of one and a half tablespoons per day (30 mL).” To that extent: (a) Since 1 ½ tablespoons may not equal 30 mL, we suggest that you re-check this conversion; (b) After you confirm the correct conversion from tablespoon to mL, the serving size listed should be 1 ½ tablespoons (about 22 mL), as an example.
  • The “(b)(4)” label’s serving size is expressed in a common household measure, but the measure is not followed by the equivalent metric quantity in parentheses in accordance with 21 CFR 101.9(b)(7).
3.    The “(b)(4)” product is misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because it fails to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii).
 
4.    The “(b)(4)” “(b)(4)” and “(b)(4)” products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. For example:
  • The “(b)(4)” label fails to present nutrition information on the nutrition label using the title “Supplement Facts” in accordance with 21 CFR 101.36(e)(1);
  • The “(b)(4)” and “(b)(4)” labels fail to place a heavy bar beneath the last (b)(2)-dietary ingredient in accordance with 21 CFR 101.36(e)(6)(ii);
  • The “(b)(4)” label fails to declare the percent of the Daily Value of the (b)(2)-dietary ingredients in accordance with 21 CFR 101.36(b)(2)(iii);
  • The “(b)(4)” label fails to bear a symbol (e.g., an asterisk) in the column under the heading of "% Daily Value" that refers to the same symbol placed at the bottom of the nutrition label and followed by the statement "Daily Value not established," except that when the heading "% Daily Value" is not used, the symbol must follow the quantitative amount by weight for each dietary ingredient listed in accordance with 21 CFR 101.36(b)(3)(iv);
  • The “(b)(4)” label declares the dietary ingredients phytomenadione, thiamine nitrate, pyridoxine hydrochloride, and methylcobalamin, but this is not the nomenclature or synonym specified for vitamin K, thiamin, vitamin B6, or vitamin B12 in 21 CFR 101.9 or 101.36(b)(2)(i)(B);
  • The “(b)(4)” label declares ascorbic acid. While this alternative name is an acceptable synonym for vitamin C, in accordance with 21 CFR 101.9(c)(8)(v), the synonym should parenthetically follow the name of the nutrient in accordance with 21 CFR 101.36(b)(2)(i)(B)(2). Furthermore, the revised label does not bear the name of the nutrient vitamin C;
  • The “(b)(4)” label declares vitamin B1 and vitamin B2. While these alternative names are acceptable synonyms for thiamin and riboflavin in accordance with 21 CFR 101.9(c)(8)(v), the synonym should parenthetically follow the name of the nutrient in accordance with 21 CFR 101.36(b)(2)(i)(B)(2);
  • The “(b)(4)” label declares “nicotinamide (equiv. niacin)” and “selenomethionine (equiv. selenium).” The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from", in accordance with 21 CFR 101.36(d);
  • The “(b)(4)” and “(b)(4)” labels do not list all of the (b)(2)-dietary ingredients in the correct order in accordance with 21 CFR 101.36(b)(2)(i)(B);
  • The source of each dietary ingredient must be designated on the label in accordance with 21 CFR 101.36(d). The “(b)(4)” label fails to declare the source of the amino acids, the “[B4]” label fails to declare the source of iron, and the “(b)(4)” label fails to declare the source of total carbohydrate and calories;
  • The “(b)(4)” label declares sugars with an amount of zero. Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), must not be declared in accordance with 21 CFR 101.36(b)(2)(i).
5.    The “(b)(4)” product is misbranded within the meaning of 403(r)(1)(A) of the Act [21 U.S.C. § 343 (r)(1)(A)] because the label bears a nutrient content claim, but the product does not meet the requirements to bear the claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(l)(A) of the Act. Specifically, the “(b)(4)” product label bears the claim “High ORAC antioxidant blend.” The antioxidant claim found on your product label is a nutrient content claim because it bears the nutrient content claim “High ORAC antioxidant blend” but does not meet the requirements to make such a claim. FDA has issued a regulation specifying the criteria for the use of the nutrient content claim “high” in food labeling (21 CFR 101.54(b)). This regulation requires a food that bears the claim to contain 20 percent or more of the Daily Value (DV) of the nutrient per reference amount customarily consumed (RACC). However, this regulation does not authorize your claim because there is no DV for the “ORAC” in your product. Therefore, the use of the term “high” to characterize the level of antioxidants in your products misbrands your product under section 403(r)(1)(A) of the Act. 
 
Further, nutrient content claims using the term “antioxidant” must also comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim, as required by 21 CFR 101.54(g)(1), and these nutrients must have recognized antioxidant activity, as required by 21 CFR 101.54(g)(2). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), as required by 21 CFR 101.54(g)(3). Further, nutrient content claims using the term "antioxidant" must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)]. The use of a nutrient content claim that uses the term “antioxidant” but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(1)(A) of the Act.
 
We note that there are alternative ways to convey the amount of the nutrients in your product to consumers. For example, the amount of a nutrient in a food may be stated on the product label or labeling in accordance with the requirements in 21 CFR 101.13(i). Percentage claims for dietary supplements may be stated in accordance with the requirements in 21 CFR 101.13(q)(3)(ii)(A) and (B). If you want to seek authorization to use your current claim, you may submit a petition requesting FDA to authorize a new nutrient content claim for one or more of the nutrients in your product (see 21 CFR 101.69). FDA’s review and authorization of a nutrient content claim prior to use in labeling ensures that the claim will provide consistent, meaningful information to consumers about the content of a product.
 
6.    The “(b)(4)” product is misbranded within the meaning of section 403(r)(6) of the Act [21 U.S.C. §343(r)(6)] because the label makes structure function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b).
 
7.    The “(b)(4)” product is misbranded within the meaning of section 403(s)(2)(A) of the FD&C Act [21 U.S.C. §343(s)(2)(A)] in that the label fails to list the name of each dietary ingredient of the supplement that is described in sections 201(ff) of the act and the quantity of each such dietary ingredient.  According to the records you provided during the inspection, the “(b)(4)” product contains the ingredient beef hydrolysate type B gelatin. The product label does not list this ingredient in accordance with 21 CFR 101.4(g) and 21 CFR 101.36(b)(3).
 
8.    The “(b)(4)” product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a 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 supplement.
 
This letter is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
 
In addition, we offer the following comments:
 
1.    The label fails to correctly declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The label declares the net quantity of contents as 946 mL but fails to include the fluid ounces.
 
2.    The “(b)(4)” label’s list of ingredients must be preceded by the term “Other ingredients” instead of “Also contains.”
 
3.    The name and place of business of the manufacturer, packer or distributor are not listed on the information panel of the “(b)(4),” “(b)(4),” and “(b)(4)” product labels in accordance with 21 CFR 101.2(b).
 
4.    The information panel on the “(b)(4),” “(b)(4),” and “(b)(4)” product labels includes ingredient information intermingled with information that is considered intervening material. Examples of intervening material are the storage information and suggested usage. Furthermore, there is intervening material between the ingredient lists and the name and address. All information appearing on the information panel of the product label should appear in one place without other intervening material in accordance with 21 CFR 101.2(e).
 
5.    Beta-carotene is not listed correctly on the “(b)(4)” Supplement Facts label. Beta-carotene may be declared as the percent of vitamin A that is present as beta-carotene. The percent must be declared to the nearest whole percent, immediately adjacent to or beneath the name vitamin A. The amount of beta-carotene in terms of micrograms (mcg) may be included in the parentheses following the percent statement in accordance with101.36(b)(2)(i)(B)(3). Furthermore, 2 mcg beta-carotene is equivalent to 1 mcg retinol; therefore, 4.3 mg of beta-carotene is not equivalent to 715 mcg retinol as you have stated on the label.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the 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, the FDA may assess fees to cover any reinspection-related costs.
  
Your response should be sent to:
  
Matthew Walburger Acting Director, Compliance Branch
Food and Drug Administration
Compliance Branch, HAF Division West 5, HFR-PA1500
19701 Fairchild
Irvine, CA 92612
 
If you have any questions about the content of this letter, please contact Sara J. Dent Acosta, Compliance Officer, at 619-941-3767. Include Special Identifier “Dent Acosta FEI # 3003128249” on all correspondence.
 
 
Sincerely,
/S/ 
Darla Bracy
Division Director, HAF West Division 5
 
 
Cc: 
David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
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