WARNING LETTER
Eden’s Answers, Inc.
MARCS-CMS 648182 —
June 28, 2023
Delivery Method:
UPS Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
Jonathan Laudon
Recipient Title
Owner
Eden’s Answers, Inc.
1701 N. 14th St., Suite A
Tampa
,
FL
33605
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
June 28, 2023
WARNING LETTER CMS # 648182
Dear Mr. Laudon:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 6399 State Route 83, Holmesville, OH from August 22 through November 9, 2022. Based on inspectional findings and subsequent review of product labels collected during the inspection, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
FDA acknowledges the receipt of the correspondences dated November 11 and December 22, 2022, and February 24, March 24, April 20, and May 16, 2023, from you and/or your consultant written in response to the Form FDA-483, Inspectional Observations, issued to you at the close of the inspection. We address the responses below, in relation to each of the noted violations.
Violations of the CGMPs for the Manufacturing of Dietary Supplements
The inspection of your facility from August 22 through November 9, 2022, 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). Based on these violations, your Dental Health, Honey Herbal Syrup, and Lil’ Ones Sleepy Time are adulterated within the meaning of section 402(g)(1) of 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.
Your significant violations of CGMP requirements are as follows:
1. You failed to establish identity specifications for each component you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1), and you failed to establish specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement, 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 to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
a. For your components, your “Eden’s Answers Raw Material Specification” sheets for catnip, chamomile, hops, oat straw, and passionflower used in the manufacture of Lil’ Ones Sleepy Time purport to establish an identity specification of “HPTLC.” However, “HPTLC” is not a qualitative or quantitative parameter to which a test result can be compared to verify the identity of the component.
b. For your finished products, your “Finished Good Specification” sheet for Lil’ Ones Sleepy Time includes the following: “Type: Liquid,” “Form: Liquid,” “Color: Amber,” and “identity: FTIR.” Specifications such as “Liquid” and “Amber” are general descriptions of the product and alone do not confirm the identity of the product. Furthermore, specifications of “Liquid,” “Amber,” and “FTIR” are not qualitative or quantitative parameters to which a test result can be compared to verify the identity, purity, strength, and composition of the dietary supplement.
For each of specification you are required to establish, you must take specific actions to determine whether the specifications are met, as required by 21 CFR 111.75. You must also ensure any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records of all activities relating to such specifications, in accordance with 21 CFR 111.95.
We have reviewed your responses dated November 11 and December 22, 2022, and February 24, March 24, April 20, and May 16, 2023. Relating to component specifications, in your February 24, 2023, response you provided a document titled “Raw Material Specification – Lemon Balm,” an ingredient used in the manufacture of your Lil’ Ones Sleepy Time dietary supplement, and your May 16, 2023, response provided Certificates of Analysis (COAs) for ingredients used in the manufacture of your dietary supplements. The February 24, 2023, response fails to provide information pertaining to identity specifications for any of the other components used in your Lil’ Ones Sleepy Time product and does not address any of the components in your Honey Herbal Syrup and Dental Health products. The COAs provided in your May 16, 2023, similarly, you do not document that you have established the required component specifications for each ingredient used in the manufacture of your dietary supplement products.
Relating to your finished products, your December 22, 2022, response purported to provide revised finished product specifications for Dental Health and Lil’ Ones Sleepy Time, and your February 24, 2023, response purported to provide revised specifications for Honey Herbal Syrup. None of the documentation, however, demonstrates that you have established the required finished product specifications. Specifically, for Dental Health, you established an identity specification for Peppermint (Leaf), but establishing an identity specification for peppermint alone will not confirm the identity of this multi-ingredient product, and the documentation you provided does not demonstrate that you have established specifications for the purity, strength, or composition of the finished product. For your Lil’ One’s Sleepy Time, you established an identity specification for Passionflower, but establishing an identity specification for passionflower alone will not confirm the identity of this multi-ingredient product, and the documentation you provided does not demonstrate that you have established specifications for the purity, strength, or composition of the finished product. For your Honey Herbal Syrup, you established an identity specification for Licorice Root and a strength specification for menthol but establishing an identity for one ingredient and a strength specification for another ingredient in this multi-ingredient product is not sufficient to confirm the identity, purity, strength, and composition of the finished product.
We also note that in establishing your identity specifications, USP chapter <621> is the general chapter for Chromatography and is not a specific test to verify the identity, purity, strength, and composition of your Dental Health, Lil’ Ones Sleepy Time, and Honey Herbal Syrup products.
2. Your batch production record fails to include the date and time of the maintenance, cleaning, and sanitizing of the 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). Specifically, your batch production records for Honey Herbal Syrup Batch 1470-01-003, Lil Ones Sleepy Time Batch 1615-01-002, and Natural Health Dental Health Batch 1560-01—003 fail to include the date and time of any maintenance, cleaning, sanitizing, or a cross reference to where this information is documented.
3. Your master manufacturing record fails to identify specifications and provide written instructions for such 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 111.205(b)(1) and 21 CFR 111.210(h)(1). Specifically, your master production record for Honey Herbal Syrup includes a step to
(b)(4)
; however, this manufacturing step does not include any temperature specifications or written instructions for controls such as monitoring and recording the time and temperature.
4. Your quality control personnel failed to conduct a material review and make a disposition decision when a batch deviates from the master manufacturing record, including when any step established in the master manufacturing record is not completed and including any deviation from specifications, as required by 21 CFR 111.113(a)(2). Specifically, your batch production record for Lil Ones Sleepy Time Batch# 1615-01-002 includes documented yield deviations from the master manufacturing record for which a quality review and disposition was not documented.
Misbranded Dietary Supplements
In addition, we reviewed product labels collected during the inspection and have determined the dietary supplement products Honey Herbal Syrup and Sleepy Time that you manufacture are misbranded under section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements. Specifically, we identified the following:
1. The Honey Herbal Syrup and Sleepy Time product labels 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 for each intended group is not declared in the Supplement Facts label.
2. The Honey Herbal Syrup and Sleepy Time product labels are each misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] because each label does not declare the number of servings per container for each intended group in the Supplement Facts label.
3. The Honey Herbal Syrup and Sleep Time product labels are misbranded within the meaning of section 403(q)(5)(F) of the Act because the nutrition information in the Supplement Facts label is not declared for each intended group in accordance with 21 CFR 101.36(b)(2)(iii)(E). The quantitative amount of the Proprietary Blend per serving for each intended group needs to be declared.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your written response to the Food and Drug Administration, Attention: Stephen J. Rabe, Compliance Officer, via email to: stephen.rabe@fda.hhs.gov and orahafeast5firmresponses@fda.hhs.gov. Or you may send hard copy correspondence to Mr. Rabe at: U.S. Food and Drug Administration 550 Main Street, Suite 4-930, Cincinnati, OH 45202.
If you have any questions regarding this letter, please contact Mr. Rabe via email or by telephone at: 513-322-0660.
/S/
Steven B. Barber
Division Director
Office of Human and Animal Food Operations
East 5
Content current as of:
07/18/2023
Regulated Product(s)
Dietary Supplements