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  1. Warning Letters

WARNING LETTER

Maison Terre, LLC MARCS-CMS 610315 —

Delivery Method:
VIA Electronic Mail
Product:
Drugs
Recipient:
Recipient Name
Sarah A. Brown
Recipient Title
Owner
Maison Terre, LLC

(b)(6)
(b)(6),
United States

(b)(6).com
Issuing Office:
Office of Pharmaceutical Quality Operations, Division II

United States

April 1, 2021

Case #: 610315

WARNING LETTER


Dear Ms. Brown:

The U.S. Food and Drug Administration (FDA) conducted testing of a drug product labeled as “Goldenseal Root Powder Organic.” This drug product was repackaged at your facility, (b)(6).

FDA determined that the “Goldenseal Root Powder Organic” drug product, repackaged at your facility, was adulterated within the meaning of section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic (FD&C) Act, 21 U.S.C. 351(a)(2)(A), in that a substance was prepared, packed, or held under insanitary conditions, whereby it may have become contaminated with filth and rendered injurious to health.

In addition, FDA determined that the “Goldenseal Root Powder Organic” drug product, repackaged at your facility, was adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B), because your facility was not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

Based on our investigation and review of your product labeling, including your firm’s websites, FDA determined that your “Goldenseal Root Powder Organic” was an unapproved new drug under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). This product was also a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352.

Furthermore, we observed that your website currently offers several essential oil products for sale to consumers including, but not limited to, “Orange (Sweet) Essential Oil 15 ml” and “Ylang Ylang 3 Essential Oil 15 ml.” FDA has determined that these are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a) and misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352.

Adulterated Drug Products

A. Insanitary Conditions

Your “Goldenseal Root Powder Organic” drug product was adulterated under section 501(a)(2)(A) of the FD&C Act because it was prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. You shared drug manufacturing space with residential food production and living space, increasing the risk of contamination of the product. For example, you generally conducted your drug manufacturing activities in your residential kitchen, rather than in a separate drug production area, and when your kitchen was undergoing repairs, you moved production to an ottoman in your living room – adjacent to the area where the repairs were taking place. You did not have any controls in place to prevent contamination of the production environment and the drug product.

Upon testing, FDA found your product to be contaminated and that it may have been injurious to health. Specifically, FDA laboratory testing of “Goldenseal Root Powder Organic,” collected at your facility, found that it contained more than 260,000 cfu/g of total aerobic microbial growth and more than 5,000 cfu/g of total yeast and mold growth.

Moreover, FDA laboratory testing also found that your “Goldenseal Root Powder Organic” drug product contained the presence of several objectionable microorganisms, including but not limited to: Enterobacter cloacae, Klebsiella pneumoniae, and Cronobacter sakazakii. These are significant opportunistic pathogens that can cause serious infections and diseases.

Both the number and type of microorganisms found in your drug product posed an intolerable risk to consumers. Such high levels of micro-contamination or objectionable microbes should not be present in any drug product, let alone one that was intended to be administered on broken skin. The use of contaminated product in otherwise healthy patients can result in infections necessitating antimicrobial and potentially surgical treatment. Individuals with weak immune systems and infants are particularly susceptible to severe infections, including risk of death. At the time we visited your facility, FDA notified you of a report of one infant death associated with use of your “Goldenseal Root Powder Organic” drug product on the umbilical cord stump.

On August 14, 2020, FDA held a teleconference with you. We recommended that you remove your “Goldenseal Root Powder Organic” drug product currently in distribution in the U.S. market. On August 14, 2020, FDA notified the public of contamination of your “Goldenseal Root Powder Organic” drug product on the following website: https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-consumers-not-use-goldenseal-root-powder-distributed-maison-terre

On August 17, 2020, you issued a voluntary recall of “Goldenseal Root Powder Organic” drug product distributed nationwide in the U.S. to customers who ordered through Amazon.com and purchased between the dates of January 25, 2015, to August 4, 2020, due to microbial contamination as noted on the following website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/maison-terre-issues-voluntary-nationwide-recall-organic-goldenseal-root-powder-due-microbial

We acknowledge your commitment during our teleconference on August 14, 2020, to cease production of “Goldenseal Root Powder Organic.” In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future.

B. CGMP Noncompliance

Your “Goldenseal Root Powder Organic” drug product was also adulterated under section 501(a)(2)(B) of the FD&C Act because the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding did not conform to or were not operated or administered in conformity with current good manufacturing practice.

1. Your firm failed to conduct appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(b).

You did not conduct any testing on the drug product you repackaged and sold for microbial attributes, including absence of objectionable microorganisms, or sterility, where appropriate. We note that the statements on your website claim that “Goldenseal Root Powder Organic” is intended for use as an “antiseptic skin bath for wounds and for internal skin surfaces.” As a drug product that is intended for use as a topical antiseptic on broken skin, it is essential that your drug products are tested for microbial contamination. Because wound site tissues are injured or diseased, they are more susceptible to infection.

2. Your firm failed to test before use each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use (21 CFR 211.84(d)(6)).

FDA identified similar levels and types of objectionable microcontamination as those found in your “Goldenseal Root Powder Organic” drug product in the bulk goldenseal root powder material you received from your supplier. As a finished drug product manufacturer, you are responsible for implementing management oversight and controls to ensure quality and safety of all materials used in manufacturing. Your firm failed to prevent use of incoming material lots that contained objectionable microbial contamination. Instead, you repacked and distributed the hazardous product to your customers.

3. Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

The gross level and types of micro-contamination in drug product manufactured in your facility also demonstrate that the quality assurance within your facility was not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the Act and FDA’s regulations at 21 CFR Parts 210 and 211. In addition, the practices you described in your affidavit, as set forth in more detail below, were consistent with an establishment that lacked an adequate quality unit to oversee the adequacy of your repacking operations and assure finished product quality (21 CFR 211.22).

4. Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups. (21 CFR 211.42(c)).

You sold various other products (e.g., herbs, oils, and spices) in addition to “Goldenseal Root Powder Organic,” yet you failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).

Photographs and an affidavit you provided to our investigators showed that you manufactured “Goldenseal Root Powder Organic” in your residential kitchen. In addition, while your kitchen disposal and dishwasher were being repaired, you temporarily manufactured product in your residential living room using an ottoman as a table. The repackaged products ready for sale were stored in the residential dining room area. You washed repackaging equipment such as the (b)(4) and cutting boards in your residential dishwasher using supermarket store-brand dishwasher pods.

You manufactured drug products with no separation between your manufacturing equipment, cooking utensils, furniture, and personal-use items. The practices you described at your facility and your lack of procedures to prevent cross-contamination increase the likelihood of contamination and/or mix-ups of your drug products.

5. Other CGMP Noncompliance

Your affidavit also demonstrated that your facility was not in compliance with other applicable CGMP requirements including the following:

  • You failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).
  • You failed to establish and follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)).
  • You did not keep inventory or distribution records (21 CFR 211.150).
  • You failed to establish written procedures to identify the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch (21 CFR 211.130(c)).
  • You failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

Marketing and Distribution of Unapproved and Misbranded “Goldenseal Root Powder Organic” Drug Product

Based on our review of your websites, your “Goldenseal Root Powder Organic” product was a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it was intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples of claims observed as recently as August 2020 on your website and Facebook page that established the intended use of your product as a drug included, but were not limited to, the following:

On a page entitled “Goldenseal” on www.maisonterre.net:

  • “Goldenseal was traditionally used by Native Americans to treat skin disorders, liver conditions, digestive problems, diarrhea, and eye irritations.”
  • “It is a mild anti-inflammatory, a strong antimicrobial, and a digestive tonic. The herb’s astringent characteristics make it useful for relieving swelling, inflammation, or infection of the throat and stomach. The yellow-tinted powder of the root also makes a good antiseptic skin bath for wounds and for internal skin surfaces, such as in the vagina and ear canal. Made into a paste with water, it is useful in treating poison ivy. For sore throats, it works well mixed with myrrh and echinacea.”
  • “The herb has been found to be effective against a number of disease-causing organisms, including Staphylococcus, Chlamydia, and Streptococcus species, E. coli, Entamoeba histolytica, Salmonella typhi, and many others. Berberine and related alkaloids in the plant have been recognized with its antimicrobial effects.”

On the product page for “Goldenseal Root Powder Organic” on www.maisonterre.net:

  • “Goldenseal root has a long history of medicinal use among Native American tribes of the northeast, its native habitat.”

On a June 20, 2013, post on your Facebook at www.facebook.com/maisonterre/:

  • “Goldenseal is so important because it improves health in many ways. It is a mild anti-inflammatory, a strong antimicrobial, and a digestive tonic. The herb’s astringent characteristics make it useful for relieving swelling, inflammation, or infections of the throat, vagina, and stomach. The yellow-tinted powder of of [sic] the root also makes a good antiseptic skin bath for wounds and for internal skin surfaces, such as in the vagina and ear canal. For sore throats, it works well mixed with myrrh and echinacea. Irritable bowel diseases also gain from the use of the herb when there is diarrhea and excessive secretions and intestinal activity.”

On a June 21, 2013, post on your Facebook at www.facebook.com/maisonterre/:

  • “Echinacea and goldenseal are both herbs that can act as a natural fever reducer and are safe to give children for shorts periods of time . . . for anti-bacterial and infection fighting benefits. Both of these plants can be brewed into a tea . . . which can also be soothing for your child if he has a sore throat or other respiratory symptoms accompanying the fever.”

Your “Goldenseal Root Powder Organic” product was also a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because it was not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There is no FDA-approved application in effect for “Goldenseal Root Powder Organic.” Thus, the introduction or delivery for introduction into interstate commerce of this product violated sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Your “Goldenseal Root Powder Organic” product was also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that its labeling failed to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) Some of the conditions for which the aforementioned product was offered are conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use could not be written so that a layperson could have used this drug safely for these intended purposes. As applicable to your product, these conditions include, for example, treatment of chlamydia. FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. See 21 CFR 201.100(c)(2) and 201.115. However, your product was not exempt from the requirement that its labeling bear adequate directions for use because no FDA-approved application was in effect for it. The introduction or delivery for introduction into interstate commerce of this misbranded drug violated section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

We note that, as of the date of this letter, it appears that you no longer appear to be marketing “Goldenseal Root Powder Organic” on your website.

Marketing and Distribution of Unapproved and Misbranded Essential Oil Drug Products

Based on our review of your website, FDA has determined that several of your essential
oil products including, but not limited to, “Orange (Sweet) Essential Oil 15 ml” and
“Ylang Ylang 3 Essential Oil 15 ml” are drugs under section 201(g)(1) of the FD&C Act,
21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease, and/or intended to affect the structure or
any function of the body.

Examples of claims observed on your website that establish the intended use of your essential oil products as drugs include, but may not be limited to, the following:

On the product page for “Orange (Sweet) Essential Oil 15 ml” on www.maisonterre.net/shop:

  • “Orange (Sweet) Essential Oil 15 ml . . . Common Uses: Properties for Sweet Orange Essential Oil are as follows: antidepressant . . .”

On the product page for “Ylang Ylang 3 Essential Oil 15 ml” on www.maisonterre.net/shop:

  • “Ylang Ylang 3 Essential Oil 15 ml. . . Common Uses: Ylang-ylang Essential Oil can assist with problems such as high blood pressure . . .”

Your “Orange (Sweet) Essential Oil 15 ml” and “Ylang Ylang 3 Essential Oil 15 ml” are also “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA approved application in effect for “Orange (Sweet) Essential Oil 15 ml” and “Ylang Ylang 3 Essential Oil 15 ml.” Thus, the introduction or delivery for introduction into interstate commerce of these products violate sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Your “Orange (Sweet) Essential Oil 15 ml” and “Ylang Ylang 3 Essential Oil 15 ml” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fail to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) Your “Orange (Sweet) Essential Oil 15 ml” and “Ylang Ylang 3 Essential Oil 15 ml” are offered for one or more conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for these intended purposes. FDA approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. See 21 CFR 201.100(c)(2) and 201.115. However, your products are not exempt from the requirement that their labeling bear adequate directions for use because no FDA approved applications are in effect for them. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

The deviations and violations cited in this letter are not intended to be an all-inclusive list of deviations and violations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and violations and for preventing their recurrence or the occurrence of other deviations and violations.

Failure to promptly address these deviations and violations may result in legal action without further notice including, without limitation, seizure and injunction. Other Federal agencies may take your compliance history into account when awarding contracts.

Failure to address violations of FD&C Act sections may be cause for FDA to withhold issuance of Export Certificates and may be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. We may conduct a follow-up inspection to verify that you have completed your corrective actions.

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 since our investigation to address any deviations and 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 completely address deviations and violations within 15 working days, state your reasons for delay and your schedule for completion.

Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Send your electronic reply to ORAPHARM2_RESPONSES@fda.hhs.gov. Please identify your response with CMS 610315.

If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

If you have questions regarding any issues in this letter related to pharmaceuticals, please contact Compliance Officer Mark Rivero at 504-846-6103 or Mark.Rivero@fda.hhs.gov.

Sincerely,
/S/

Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II

 
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