Seattle District Office
22215 26th Avenue SE, Suite 210
Bothell, Washington 98021
May 25, 2017
In reply refer to Warning Letter SEA 17-15
Tierney P. Salter, President and Owner
The Herbalist, Inc.
10559B Ravenna Ave NE
Seattle, Washington 98125-7745
Dear Ms. Salter:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 10559B Ravenna Avenue NE, Seattle, Washington, on October 24, 25, 26, 28, 2016, and November 4, 2016. During the inspection, our investigators evaluated your dietary supplement manufacturing, packaging, labeling, and holding operations and identified significant violations of the dietary supplement Current Good Manufacturing Practice (CGMP) regulations found in 21 CFR Part 111. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)], in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements. In addition, this is to advise you that the FDA reviewed your website at the Internet address www.theherbalist.com on May 23, 2017, and determined that you take orders for the products: Prostate Choice, Wormwood Capsules, Immuno-Blast, Ache-Less, and Kids Be Calm, among others. In addition, you promote products through your informational pages including, but not limited to Asthma, Breast Health, Candida, and Respiratory System & Cardiovascular System. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drugs
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include, but are not limited to:
“Studies have demonstrated the effectiveness of Saw Palmetto in reducing symptoms such as frequent, painful urination with reduced urine flow…Goldenrod has strong antiseptic properties…Plantain and Ginger have…anti-inflammatory properties…”
“[W]orm-wood” is used to cleanse the body of worms and other parasitic invaders…It is a powerful anti-parasitic agent that is effective at killing both mature parasites as well as their larvae.”
“[P]rovides a blast to the immune system…specific for boosting immunity against colds and flu.”
“[U]sed to calm inflammation and relieve temporary aches and pains…contains Jamaican Dogwood, an herb with anti-spasmodic properties to soothe aches…can promote quicker healing from minor strains, sprains…analgesic and anti-spasmodic effect, Ache-Less is useful for a wide range of conditions related to pain and inflammation, such as menstrual cramps …”
Kids Be Calm:
“[A]nd deters the pains of teething…”
In addition to therapeutic claims found for single products, your firm’s web pages also contain medical information pages that list individual products, such as:
“Asthma is a potentially life-threatening condition … stress or anxiety can cause an asthmatic person to have an episode … the bronchial muscles spasm, swell and close causing constriction of the air passage. The mucus membranes that line the air passage swell and over-produce mucus. Breathing becomes constricted, and can cause wheezing and coughing. Herbal treatments for asthma involve decreasing inflammation of the bronchiole tissues, opening the air passageway, tonifying mucus membranes, modulating immune function and providing symptomatic relief.”
Products promoted for sale on this page include Antispasmodic Tonic and Quercetin Nettles Plus, Allergies.
“[H]erbal and natural therapies can do wonders at preventing breast cancer and fibrocystic conditions.”
Products promoted on this page include Lymphatone, Namaste Tea, Chaste Tree Berry Liquid Extract, and Ultimate C 500mg—Herbalist Private Label.
“Thrush and vaginal yeast infections are two painful diseases caused by candida overgrowth … anti-fungal and immune-stimulating herbs work to cleanse the body of excess candida.”
Products promoted for sale on this page includes: Beat the Yeast Triple Kit and Fungal Defend.
Respiratory System & Cardiovascular System:
“[H]elps to clear respiratory challenges such as asthma, bronchitis, respiratory congestion and coughing … support the health of the heart, healthy veins, and circulation.”
Products promoted for sale on this page include: Ache-Less, Ache-Less Rub, Antispasmodic Tonic and Cough-Eze Syrup.
Your Prostate Choice, Wormwood Capsules, Immuno-Blast, Kids Be Calm, Beat the Yeast Triple Kit, Fungal Defend, Ache Less, Ache-Less Rub, Antispasmodic Tonic, Quercetin Nettles Plus, Allergies, Lymphatone, Namaste Tea, Chaste Tee Berry Liquid Extract, Ultimate C 500 mg—Herbalist Private Label, and Cough-Eze Syrup products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 301(d) and 505(a) of the Act [21 U.S.C. §§ 321(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your Ache-Less, Ache-Less Rub, Antispasmodic Tonic, Blood Pressure Be Well, Circutone, Cough-Eze Syrup, Ener-CHAI-Zing Tea, Healing Heart, Lung Defend, Respiratory Rescue Triple Kit, and Respitonic are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Ache-Less, Ache-Less Rub, Antispasmodic Tonic, Blood Pressure Be Well, Circutone, Cough-Eze Syrup, Ener-CHAI-Zing Tea, Healing Heart, Lung Defend, Respiratory Rescue Triple Kit, and Respitonic fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
During our inspection, our investigators observed the following significant violations of the dietary supplement CGMP regulations, which were noted on the Form FDA 483, Inspectional Observations, issued to you on November 4, 2016. We reviewed your responses received on November 29, 2016, January 5, 2017, February 16, 2017, and April 3, 2017, and have addressed relevant information in the responses below.
1. You failed to establish specifications for each dietary supplement that you manufacture for the identity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically,
- Your finished product specification provides for organoleptic testing for establishing the identity of the dietary supplement. However, organoleptic analysis may not be an appropriate method of testing for certain substances. This is particularly true when the nature of the substance decreases the reliability of organoleptic analysis. For example, while organoleptic analysis may be an appropriate identity test for whole or coarsely-cut botanical parts, it may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur [72 FR 34852 (Jun. 25, 2007)].
- Your finished product specifications fail to include specifications for strength and composition. For example, your specifications do not include acceptance criteria for composition for the range of alcohol content in the finished product. Even though the plant material may contribute to the amount of moisture/water, and this may result in % alcohol variance, this does not absolve you from the requirement to establish a specification. You could establish a wider range specification.
Once you establish these specifications, you must determine whether the specifications have been met, in accordance with 21 CFR 111.75(c).
Misbranded Dietary Supplements
1. Your Echinacea Root, Ache-Less, Immuno-Blast, Kids Be Calm, Dream Sleep, and Sinutone 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 labels fail to bear nutrition labeling in the form of a (“Supplement Facts”) label, as required by 21 CFR 101.36.
2. Your Echinacea Root, Ache-Less, Immuno-Blast, Kids Be Calm, Dream Sleep, and Sinutone products are misbranded within the meaning of sections 403(s)(2)(A)(ii)(I) and 403(q)(5)(F) of the Act [21 U.S.C. § 343(s)(2)(A)(ii)(I) and 343(q)(5)(F)] in that the labels fail to list the quantitative amount by weight per serving size of all the dietary ingredients, as required by 21 CFR 101.36.
3. Your Ache-Less, Immune Blast, Kids Be Calm, Dream Sleep, and Sinutone products are misbranded within the meaning of section 403(q)(1)(B) of the Act [21 U.S.C. § 343(q)(1)(B)] in that the labels fail to list the servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration, as required by 21 CFR 101.36(b)(1)(ii).
4. Your Echinacea Root product is misbranded within the meaning of section 403(s)(2)(A)(i) of the Act [21 U.S.C. § 343(s)(2)(A)(i)] in that the label fails to list the name of each ingredient of the supplement that is described in section 201(ff).
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. 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 your firm complies with the Act and FDA regulations.
We also offer the following comment:
Your Sinutone, Immuno-Blast, and Dream Sleep product labels abbreviate part of the Latin binomial that is stated in the ingredients list and that should not be abbreviated. An additional Latin botanical that contains the same genus as that contained in a previously listed Latin binomial may be abbreviated.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, including, without limitation, seizure and injunction.
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 re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter describing the specific steps you have taken to correct the noted violations, and to prevent these violations, or other similar violations, from occurring again. You should include documentation of corrective actions you have taken to date. If your firm’s planned corrections will occur over time, please state the reason for the delay and include a timetable for implementation of those corrections.
Your reply should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Patricia A. Pinkerton, Compliance Officer. Refer to the identification number WL SEA 17-15 when replying. If you have any questions regarding any issues in this letter, please contact Compliance Officer Patricia Pinkerton by telephone at 425-302-0428.
Miriam R. Burbach
cc: Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560
This page was posted on April 30, 2019.