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CRITICALPharmacy / Compounding

Maison Terre, LLC

FDA issued a warning letter to Maison Terre, LLC (owner Sarah A. Brown) for repackaging and selling 'Goldenseal Root Powder Organic' under insanitary conditions — including in a residential kitchen and living room — resulting in dangerous microbial contamination (including Cronobacter sakazakii and Klebsiella pneumoniae) linked to at least one infant death. The products were found to be unapproved new drugs and misbranded under the FD&C Act, and the firm also marketed essential oils ('Orange (Sweet) Essential Oil' and 'Ylang Ylang 3 Essential Oil') with unapproved drug claims. FDA demanded a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.

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

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.

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

Goldenseal was traditionally used by Native Americans to treat skin disorders, liver conditions, digestive problems, diarrhea, and eye irritations.

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 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.

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.

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

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.

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.

Failure to promptly address these deviations and violations may result in legal action without further notice including, without limitation, seizure and injunction.

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