WARNING LETTER
Elemental Herbs Inc. d/b/a ALL good
MARCS-CMS 654879 —
October 20, 2023
Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Ms. Caroline M. Duell
Recipient Title
CEO and Founder
Elemental Herbs Inc. d/b/a ALL good
PO Box 203
Morro Bay
,
CA
93443
United States
(b)(6), (b)(7)(C)
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
WARNING LETTER
October 20, 2023
Dear Ms. Duell:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Elemental Herbs Inc., doing business as “ALL good,” FEI 3012013973, at 1149 Market Avenue, Morro Bay, from January 23 to February 3, 2023.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
In addition, “ALL good Goop Skin Recovery Balm” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d). Further, “ALL good Goop Skin Recovery Balm” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such a product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.
We reviewed your February 22, 2023 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate  because it did not provide sufficient detail or evidence of corrective actions to bring your operations into compliance with CGMP.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).
Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products, for example:
Adequate procedures were not in place describing and defining the roles and responsibilities between your QU and your contract manufacturing organizations(CMOs). For example, there were inadequate or no procedures for:
o Qualification of CMOs to manufacture your drug products
o Establishment of drug product specifications
o Sharing complaints with CMOs
o Management of changes
o Investigation of product returns
Out-of-specification (OOS) results generated by your contract laboratories were not appropriately investigated by your firm. For example, an investigation was not conducted by your firm when OOS results for Zinc Oxide assay were reported at multiple timepoints during real time stability testing of your “ALL good” SPF-20Coconut lip balm. Furthermore, your firm did not communicate these OOS results in a timely manner to the CMO that manufactured this drug product for you.
Without adequate quality procedures and oversight, you cannot ensure the consistency of your manufacturing processes and the purported identity, strength, quality, and purity of drug products released to the market.
In your response, you plan to hire a consultant to establish Quality Systems and commit to develop standard operating procedures (SOPs) including, but not limited to, the proper handling of OOS results.
Your response is inadequate. You do not identify or implement any interim actions that will be undertaken to correct or prevent the significant QU violations and do not provide a timeframe for when corrective actions and preventive actions (CAPAs) will be instituted.
Your firm’s quality systems are inadequate. See FDA’s guidance document
Quality Systems Approach to Pharmaceutical CGMP Regulations
for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, at https://www.fda.gov/media/71023/download.
For more information about handling failing OOS, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s Guidance document
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision
In response to this letter, provide:
A comprehensive assessment and remediation plan to ensure your QU is given theauthority and resources to effectively function. The assessment should also include,but not be limited to:
o A determination of whether procedures used by your firm are robust and appropriate
o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
o A complete and final review of each batch and its related information before the QU disposition decision
o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
Describe how top management supports quality assurance and reliable operations, including but not limited, to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.
A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following:
o QU oversight of laboratory investigations
o Identification of adverse laboratory control trends
o Resolution of causes of laboratory variation
o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified
o Adequately scoping of each investigation and its CAPA
o Revised OOS investigation procedures with these and other remediations
2. Your firm failed to follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
Your firm failed to establish an adequate stability program and determine appropriate expiration dates for over-the-counter (OTC) drug products that you own and distribute, specifically:
Your firm marketed at least seven Sun Protection Factor (SPF) drug products within adequate data to support their labeled expiration date.
Your firm failed to establish an adequate stability program for OTC drug products.
Your firm failed to put a representative sample of all drugs in unique container closure systems in a stability testing program.
In your response, you commit to doing a complete review of the stability program being performed by your CMOs. You state that this review will take at least
(b)(4)
from initiation. However, a proposed initiation date is not provided.
Your response is inadequate. You fail to provide updated stability protocols to ensure all unique product types are included in your stability program. Additionally, your response does not include a timeline for remediation of your stability program.
In response to this letter, provide the following:
A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to
o Stability indicating methods
o Stability studies for each drug product in its marketed container-closure system before distribution is permitted
o An ongoing program in which representative batches of each drug product are added each year to the program to determine if the shelf-life claim remains valid
o Detailed definition of the specific attributes to be tested at each station(timepoint)
o All procedures that describe these and other elements of your remediated stability program.
Contractor’s Responsibilities
Drugs must be manufactured in conformance with CGMP. The FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. The FDA regards contractors as extensions of the manufacturer.
You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. You are required to ensure drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Unapproved New Drug and Misbranding Violations
“ALL good Goop Skin Recovery Balm” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, “ALL good Goop Skin Recovery Balm” is intended for use as an OTC skin protectant and an OTC external analgesic.
Examples of claims from the “ALL good Goop Skin Recovery Balm” labeling, including the website https://allgoodproducts.com/ that is listed on the product label, that provides evidence of the intended uses (as defined by 21 CFR 201.128) of this product include, but may not be limited to, the following:
“ALL good Goop Skin Recovery Balm”
“Goop is great on cuts, scrapes, cracked heels, burns, bites and almost anything that needs soothing;” “skin recovery;” “Things that people have used ALL good Goop for: cuts, scrapes, abrasions, minor burns, sunburns, insect bites, stings, dry and irritated skin, itchy eczema, chapped lips, cracked cuticles, diaper rash, blisters, cracked or calloused hands, scars, booboos (fine for kids!);” [from your product website, (https://allgoodbodycare.com/)].
Unapproved New Drug Violations
Based on the above labeling claims, “ALL good Goop Skin Recovery Balm” is intended for use as an OTC skin protectant and an OTC external analgesic. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).
A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from the FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “ALL good Goop Skin Recovery Balm.”
Your “ALL good Goop Skin Recovery Balm” is a drug product that combines skin protectant and external analgesic active ingredients subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to OTC skin protectant and external analgesic drug products, such products are deemed to be GRASE and not new drugs if, among other things, they conform to the conditions of use set forth in applicable final administrative orders. OTC skin protectant drug products are addressed in the over-the-counter Monograph M016: Skin Protectant Drug Products for Over-the-Counter Human Use (hereinafter “M016” or “skin protectant monograph”) and OTC external analgesic drug products are addressed in the over-the-counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (hereinafter “M017” or “external analgesic monograph”).
1
However, “ALL good Goop Skin Recovery Balm” does not conform to the conditions specified in either final administrative order for the reasons described below.
Your “ALL good Goop Skin Recovery Balm” is not formulated as a skin protectant drug product or external analgesic drug product that is consistent with the applicable final administrative orders. Specifically, your product is labeled to contain the ingredients Organic Olea Europaea (Extra Virgin Olive Fruit Oil, Pure Cera Alba (Beeswax), Organic Calendula, Officinalis (Calendula), Organic Symphytum Officinale (Comfrey), Organic Plantago Lanceolata (Plantain), Organic Lavandula Angustifolia (Lavender), Organic Achillea Millefolium (Yarrow), Non-GMO Tocopherol (Vitamin E) and Organic Lavandula Angustifolia (Lavender) Essential Oil, all of which are outside of the active ingredients permitted in OTC skin protectant and analgesic drug products by the applicable final administrative orders. This combination of active ingredients is not permitted under the applicable final orders nor are any of these ingredients permitted as a single active ingredient in a skin protectant or external analgesic drug product marketed without an approved application under section 505G.
Furthermore, to the extent your “ALL good Goop Skin Recovery Balm” product contains beeswax that is intended as an active ingredient, it would also fall under section 505G(a)(5) of the FD&C Act, because the FDA has determined that no skin protectant products containing beeswax as an active ingredient are generally recognized as safe and effective under a final determination issued under 21 CFR part 330.
2
Thus as formulated, “ALL good Goop Skin Recovery Balm” does not comply with the applicable final administrative orders described above or any other final order.
3
Therefore, “ALL good Goop Skin Recovery Balm” is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No FDA-approved application pursuant to section 505 of the FD&C Act is in effect for this drug product. Accordingly, “ALL good Goop Skin Recovery Balm” is an unapproved new drug marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section and 301(d) of the FD&C Act, 21 U.S.C. 331(d).
Misbranding Drug Violations
“ALL good Goop Skin Recovery Balm” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because it is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section, and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Additionally, we note that all of your hand sanitizer labels collected during the inspection are marketed as “hand sanitizers.” Hand sanitizers generally refer to consumer or health care antiseptic rubs. However, the labels of your hand sanitizers also suggest that they can be used as consumer or health care antiseptic washes. For instance, the label states that the products can be used “For hand washing to decrease bacteria on skin.” An ethyl alcohol (ethanol) drug product marketed under section 505G of the FD&C Act cannot be a consumer or health care antiseptic wash because ethanol (in any concentration) is not an active ingredient permitted for use in consumer or health care antiseptic hand washes.
4
Furthermore, the labeling of some of your “ALL good” SPF products fails to comply with the formatting requirements of the Drug Facts labeling regulation at 21 CFR 201.66. For example, some product labels are missing the title “Drug Facts” as required under 201.66(c)(1) and include extraneous verbiage, which is not permitted as described under 201.66(d)(7).
The above general comments are not all-inclusive of the labeling issues that may be presented by your products. Should you have further questions concerning the labeling of drug products, we recommend that you retain the services of a reputable food and drug law consultant or attorney for assistance.
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Failure to address violations may also cause the FDA to withhold issuance of Export Certificates. The FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Please send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food and Drug Administration
19701 Fairchild Road
Irvine, CA 92612-2506
Please identify your responses with the unique identifier:
CMS 654879
.
If there are any questions about the released information, please contact Yumi Hiramine, compliance officer, at Yumi.Hiramine@fda.hhs.gov or at 818-226-1839.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
_________________________
1
Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs," notably, conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR part 330 prior to enactment of the CARES Act. In the case of OTC skin protectant drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M016: Skin Protectant Drug Products for Over-the-Counter Human Use (See Order ID OTC000005, available at FDA's website OTC Monographs@FDA, https://dps.fda.gov/omuf). In the case of OTC external analgesic drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use (See Order ID OTC000033, available at FDA's website OTC Monographs@FDA, https://dps.fda.gov/omuf).
2
FDA's final determination was codified in regulations at 21 CFR 310.545(a)(18)(i)(B). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) are deemed to be a final administrative order. The final administrative order is entitled "Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses" (See Order ID OTC000007, available at OTC Monographs@FDA, https://dps.fda.gov/omuf).
3
FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that "ALL good Goop Skin Recovery Balm" is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling.
4
Section 505G of the FD&C Act addresses nonprescription drugs marketed without an approved application. Under section 505G(a)(3) of the FD&C Act, drugs that were classified as Category Ill for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330 - and that were not classified as Category II for safety or effectiveness - are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements. The permitted active ingredients for consumer washes are set forth here: "Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use," Proposed Rule, 78 FR 76444 (December 17, 2013) and "OTC Safety and Effectiveness of Topical Antimicrobial Drug Products for Over-the-Counter Human Use," Final Rule, 81 FR 61106 (September 6, 2016). The permitted active ingredients for health care personnel washes are set forth here: "Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record," Proposed Rule, 80 FR 25166 (May 1, 2015) and "Safety and Effectiveness of Health Care Antiseptics;Topical Antimicrobial Drug Products for Over-the-Counter Human Use," Final Rule, 82 FR 60474 (December 20, 2017).
Content current as of:
11/21/2023
Regulated Product(s)
Drugs