• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Herbalist and Alchemist, Inc. 9/19/13

  

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

Public Health Service
Food and Drug Administration
 

Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
 

Telephone (973) 331-4900
 

 

September 19, 2013
 

WARNING LETTER

VIA -United Parcel Service
Elizabeth Lambert
Chief Executive Officer
Herbalist and Alchemist, Inc.
51 S Wandling Avenue
Washington, New Jersey 07882-2133
 

Dear Ms. Lambert:
 

13-NWJ-13
 

The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 51 S. Wandling Avenue, Washington, New Jersey from October 22, 2012 through November 16, 2012.

During the inspection, we documented serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. These violations cause 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 the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements (21 CFR Part 111).

Additionally, our investigators collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. Based on our review, your (b)(4) Lung Relief Anti-Spasmodic, (b)(4) Kidney Relief, Men's Prostate Tonic, (b)(4) Women's Anti-Spasmodic Compound, Pancreaid, Immune Adapt, and Thyroid Calmpound dietary supplement products are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with FDA's labeling regulations under 21 CFR Part 101.

We acknowledge receipt of your letters, dated December 7, 2012, and March 15, 2013, in response to the Form FDA-483, and address your specific responses below.

You may find the Act and its implementing regulations through links on FDA's home page at http://www.fda.gov.

Adulterated Dietary Supplements

Your dietary supplement products are adulterated based on the following significant violations:

1. You failed to perform at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient before use, as required by 21 CFR 111.75(a)(1)(i), and you did not petition FDA for an exemption from this requirement as set forth in 21 CFR 111.75(a)(1)(ii). You also 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, as required by 21 CFR 111.70(b)(2). Specifically:
 

• Celery Seed Extract Lot# CLS 13, Parsley Extract Lot# PAR 15, Buchu Extract Lot #BUC 12, Com Silk Extract Lot# CSK 30, Pipsissewa Extract Lot #PIP 21 were used in the manufacture of the finished product (b)(4) Kidney Relief Lot #1 without performing an adequate identity test on the incoming dietary ingredients and without establishing the required component specifications. The identity test you perform is based on a non-specific specification for the liquid form of the extract; an organoleptic test is not a sufficient test for an extract once it is removed from the botanical.
 

(b)(4) Extract Lot # LMB 66 and LMB 65 were used in the manufacture of finished product Thyroid Calmpound Lot #36 without performing an adequate identity test on the incoming dietary ingredients and without establishing the required component specifications. The identity test you perform is based on a non-specific specification for the liquid form of the extract; an organoleptic test is not a sufficient test for an extract once it is removed from the botanical. Motherwort Lot # MTW 66 and Bugleweed Lot # BGL 28 were used in the manufacture of finished product Thyroid Calmound Lot #36 without establishing the required component specifications.
 

(b)(4) Lot #10-247 was used in the manufacture of finished product (b)(4) Extract Lot# BCK-55 without performing an adequate identity test on the incoming dietary ingredient and without establishing the required component specifications. The identity test you perform is based on a specification for fresh root/rhizome that is inadequate; for example, in your comparison of A. racemosa to the possible adulterants A. pachypoda, A. rubra, and A. cimicifuga, you stated that the identity characteristic for the later species are not described in the literature. Therefore, you do not have a specific characteristic by which to distinguish between the desired rhizome and the adulterants.
 

We have reviewed your response letter, dated December 7, 2012, and determined your response to be inadequate. You state on page 3 of 120 of your response letter that ''we determined that our specification for purity for single whole botanical raw materials would read: 'There should be no off odors associated with, but not limited to, mold, rancidity or non-plant matter.' In so doing, we have also provided more detail in our specification for identity." We do not agree that purity of a botanical ingredient can be determined by smell alone. Moreover, purity and identity are separate requirements.

You also state on page 5 of 120 of your December 7, 2012, response letter that "The purity of the dietary ingredient single herb liquid extract is encompassed by meeting strength and composition requirements. Each batch of single herb liquid extract is verified by Quality Control to have the appropriate composition which is also verification of the strength and purity of the product. The Preamble describes "the term 'purity' to refer to the identity and amount of a dietary supplement that is the desired product... "". However, your specifications do not define what the "appropriate composition" is.

Your December 7, 2012 letter refers to Exhibit XI (page 34 of 120) for the specifications of Celery Seed Extract as an example of specifications. However, the specification table is inadequate. For example:
 

• The entry for Identity in the "Acceptable Limits" column (which would be more accurately titled "Acceptance Criteria") in the specification table is "(b)(4)." The latter is a non-specific description of the liquid form of the extract. The entry does not constitute an identity test.
 

• Similarly, the entry for Purity is inadequate: "[a]romatic aroma" is not a standard test for purity.
 

• The entry in the column for composition is "contains Celery seed extracted in (b)(4) content by input" is not acceptable because relying on how much ethanol you put in does not indicate what the end composition of the extract is.
 

• The entry for strength in the "Acceptance Limits" column is "(b)(4)", and the entry in the "Test Method" column is "(b)(4)". Neither of these entries is adequate, because neither entry is an analytical method to measure the strength, or concentration, of the extract.
 

• Finally, the limits of heavy metals are quoted as maximum daily consumption (mcg/day), and not as the upper limit allowed in the product. Maximum daily consumption is not an appropriate unit of measure for the limits of heavy metals. In addition, a description of the analytical method is not provided.
 

The specification table for the (b)(4) Extract, (b)(4) and all remaining specification tables follow the same pattern and contain the same inappropriate entries and are therefore also inadequate. Once you establish component specifications, you must verify that those specifications have been met under 21 CFR 111.75(a)(2).

2. You failed to establish product specifications for the purity, strength, and composition of the finished batch of dietary supplement products for each dietary supplement that you manufacture, as required by 21 CFR 111.70(e). Specifically, you did not establish product specifications for the following finished batches of products:
 

(b)(4) Kidney Relief Lot #1
• Thyroid Calmpound Lot #36
(b)(4) Extract Lot #BCK-55
(b)(4) Full Moon, Lot #49
(b)(4) Lung Relief, Lot #25
• Men's Prostate Tonic, Lot #99
 

We have reviewed your response letter, dated December 7, 2012, and determined your response to be inadequate. You state on page 7 of 120 of the response letter, under the subtitle "Purity" that "The purity of the dietary supplement single herb liquid extracts is encompassed by meeting strength and composition requirements. Each batch of finished dietary supplement single herb liquid extract is verified by Quality Control to have the appropriate composition which is also verification of the strength and purity of the dietary supplement. The Preamble describes "the term 'purity' to refer to the identity and amount of a dietary supplement that is the desired product..."". However, you do not defme what the "appropriate composition" is. You state on page 8 of 120 that you will "establish a separate Specification for each single herb liquid extract that describes all the specifications in one document." You provide the Specifications of (b)(4) Extract, Exhibit XIII (page 36 of 120) as an example of specifications of the dietary supplement products. The specification table for (b)(4) Extract is inadequate because, for example, \ the entry for Purity is inadequate: "faint, disagreeable aroma" is not a standard [test] or a specific test for purity. Purity cannot be determined organoleptically. Chromatography or high-performance liquid chromatography compared against an acceptable standard would be an acceptable test for purity.

Once you establish finished product specifications, you must verify that those specifications have been met under 21 CFR 111.75(c).

3. You failed to monitor the in-process points, steps, or stages where control is necessary to ensure the quality of the finished batch of dietary supplement to determine whether the in-process specifications are met and detect any deviation or unanticipated occurrence that may result in a failure to meet specifications, as required by 21 CFR 111.75(b). Specifically, you did not provide any evidence of in-process testing to ensure the quality of any of the numerous liquid dietary supplements you manufactured.

We have reviewed your response letter, dated December 7, 2012, and determined your response to be inadequate. For example, you state that on page 9 of 120 "all single herb liquid extract batches are verified by Quality Control through in process batch record review to meet specifications for purity, strength, and composition." However, as indicated above, the specification tables are deficient; therefore, the statement regarding batch record review by Quality Control to verify that the product specifications are met is not applicable because the specification tables are inadequate.

Misbranded Dietary Supplements:

Your (b)(4) Lung Relief Anti-Spasmodic, (b)(4) Kidney Relief, Men's Prostate Tonic, (b)(4) Women's Anti-Spasmodic Compound, Pancreaid, Immune Adapt, and Thyroid Calmpound dietary supplement 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 "Supplement Facts" nutrition labeling is not in the correct format in accordance with 21 CFR 101.36. Specifically,
 

• the quantitative amount by weight per serving of the proprietary blend is not declared [21 CFR 101.36(c)(3)].
 

• the nutrition information is not enclosed in a box by using hairlines and does not otherwise comply with the formatting requirements in 21 CFR 101.36(e).
 

The above violations are not intended to be an all-inclusive list of deficiencies at your facility. 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 all of your firm's products are in compliance with federal laws and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violation may result in enforcement action, without further notice, including seizure and/or injunction.

In addition to the above violations, we have the following comment:

You include a "Best By" date on some of your dietary supplement products. For example, the label of your Thyroid Calmpound lists a "Best by" date of 08/14. Similarly, the label of (b)(4) lists a "Best by" date of 09/15. Please note that the term "shelf life dating" includes expiration dating and ''best if used by" dating [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007). Any expiration date or "Best by date" you place on a product label should be supported by data [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007).

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations, including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.

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 non-compliance 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer at 973-331-4904.
 

Sincerely,
/S/

Diana Amador-Toro
District Director
New Jersey District