- Prime Health Products
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
July 29, 2015
VIA EXPRESS MAIL
Julia C. Wong
President and Owner
Prime Health Products
133 The West Mall, Unit 8
Toronto, Ontario, Canada M9C1C2
Dear Ms. Wong:
In June 2015, the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.sensiblehealth.com, and have determined that you take orders for your products described below. In addition, from September 8-10, 2014, we conducted an inspection of your dietary supplement manufacturing facility located at 133 The West Mall, Unit 8, Toronto, Ontario, Canada. Based on our review of your website, the inspection, and review of the product labels that you provided during the inspection, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA's website at www.fda.gov
Unapproved Drugs/Misbranded Drugs
The claims on your website establish that Liver/Gallbladder Flush 4-Pack, Chinese Bitters, Gold Coin Grass (GCG), Coptis, Curcuma, Chrysanthemum, Meta Plus, Shou Wu Tea, Taheebo Tea, Kidney Tea, Plantago Seeds, Black Sesame Seeds, and Boat-Fruited Sterculia Seeds are drugs under Section 201(g)(1)(B) of the Act [21 United States Code (U.S.C.) § 321(g)(1)(B)] because they are intended for use in the diagnosis, 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.
The claims observed on your website www.sensiblehealth.com include, but are not limited to, the following:
On the homepage:
"[A] weak liver can be the cause of many chronic health problems. Gallbladder problems... , sleep disorders... skin problems... allergies, arthritis, thyroid problems, hypoglycemia, frequent numbness in the extremities, frequent infection... In addition, womens' health problems such as uterine fibroids... endometriosis, painful menstruation, and possibly even some cancers may also be the result of a weak liver... The herbs I used in treating myself are described in Properties of Herbs. All herbal tinctures I developed are manufactured by and available exclusively from Prime Health Products..." "Testimonial" from Julia Chang (firm owner)
"Prime Health Products manufactures a unique collection of all-natural Chinese herbal tinctures for chronic health problems without using drugs... gallbladder problems and gallstone removal... endometriosis... insomnia, arthritis, thyroid disorders, allergies... "
From individual product pages:
"Liver/Gallbladder Flush 4-Pack... In Chinese medicine, it is traditionally used to prevent and expel gallbladder stones and kidney stones... Chinese Bitters... appears to have antihypertensive and vasorelaxant properties... In Chinese medicine, this herb has anti-inflammatory and toxin-purging properties, and it is used to treat digestive disorders... Coptis... appear to have anti-hypertensive... anti-arrhythmic, and anti-bacterial properties... its anti-inflammatory and toxin-purging properties, but its area of effect is the heart, large intestine, liver, and stomach... Curcuma... which appear to have anti-inflammatory effects... Some research suggests it may also have other effects, including anti-cancer effects, although that research is still preliminary... It is said to eliminate jaundice in the gallbladder... Chinese Bitters... because it has been traditionally used to help with female-specific problems such as... ovarian cysts, uterine fibroids... and endometriosis. Some women with fertility problems use it to help...in order to become pregnant...Chrysanthemum... Orally, Chrysanthemum is used to help with angina, hypertension, type 2 diabetes, fever, cold, headache, dizziness... "
Select testimonials from Gallstones and Gallbladder Problems page:
"From Theresa W... gold coin grass... on the right road to recovery after suffering for so many years from... chronic fatigue, adrenal fatigue, IBS/sluggish bowel, anemia and fibromyalgia... "
From the Frequently Asked Questions (F AQ) page:
"Do you have any remedies for high cholesterol levels?... Cholesterol is metabolized by the liver. A weak liver that fails to metabolize cholesterol efficiently would cause cholesterol to accumulate more quickly than it would with a strong liver. A weak liver also weakens the gallbladder, and a weak gallbladder usually forms gallstones. You may have to cleanse both the liver and gallbladder in order to have an efficient liver... had high cholesterol for years. After taking different cholesterol pills for 5 years with no success, she decided to try our Chinese Bitters, GCG, Coptis and Curcuma before doing liver and gallbladder flush. Her cholesterol level came down from 330 to 240 after only one flush. Chinese Bitters should help your cholesterol problem if your gallbladder is not a problem yet. However, if you do have gallstones, they have to be eliminated before your liver can be efficient... "
In addition, the claims on your website and product label establish that Prime Herbal Mouthwash and Mu Shang Aluminum-Free Herbal Deodorant are drugs under sections 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321 (g)(l)(B) and (C)] because they are intended to cure, mitigate, treat, or prevent disease or to affect the structure or function of the body of man or other animals. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
The claims observed on your products' labeling include, but are not limited to, the following:
From product labels:
Prime Herbal Mouthwash- "Antibacterial... "
From your website, www.sensiblehealth.com:
"Prime Herbal Mouthwash... This product contains the antibacterial and anti-inflammatory herbs... which help fight... gum disease... and other oral problems. It can also be applied externally on minor skin ailments such as pimples, inflammation or cuts. It can also be gargled to help with a sore throat... "
"Saussurea (Mu-hsiang) [listed as an ingredient in Prime Herbal Mouthwash]... alleviates pain. Conditions most used for are... diarrhea and dysentery... It is an antiseptic... "
"Mu Shang Aluminum-Free Herbal Deodorant... uses anti-bacterial and anti-fungal ingredients to kill the source of the body odour... "
Your Liver/Gallbladder Flush 4-Pack, Chinese Bitters, Gold Coin Grass (GCG), Coptis, Curcuma, Chrysanthemum, Meta Plus, Shou Wu Tea, Taheebo Tea, Kidney Tea, Plantago Seeds, Black Sesame Seeds, Boat-Fruited Sterculia Seeds, Prime Herbal Mouthwash, and Mu Shang Aluminum-Free Herbal Deodorant products are not generally recognized as safe and effective for the above referenced uses and, therefore, 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 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331 (d)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Furthermore, your Chinese Bitters, GCG (Gold Coin Grass), Coptis, Curcuma, Chrysanthemum, Kidney Tea, Shou Wu Tea, Taheebo Tea, and Plantago Seeds products are offered for 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 these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
Even if the aforementioned products were not unapproved new drugs, your Chinese Bitters, GCG (Gold Coin Grass), Coptis, Curcuma, Chrysanthemum, Meta Plus, and Fern-mate products, as dietary supplements, are adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(l)] because they have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice regulation for dietary supplements found in Title 21 Code of Federal Regulations, Part 111 (21 CFR 111). At the close of our inspection, you were advised of these issues in the issued Form FDA-483, Inspectional Observations. We acknowledge your written responses of October 1, 2014, and February 19, March 18, and March 25, 2015.
Our inspection revealed the following violations:
1. Your firm failed to establish specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, as required by 21 CFR 111.70(e). Specifically, you have offered no evidence demonstrating that such specifications have been established for any of your products.
Once you establish product specifications, you must verify that these specifications are met by testing or examining, (1) every finished batch, or (2) a subset of finished batches for each of finished hatched for each of the dietary supplements you manufacture as required by 21 CFR 111.75(c). If you test a subset of finished batches, you must identify the subset using a sound statistical plan [21 CFR 111.75(c)].
We note that the specific gravity measurements taken for finished batches of your products are not scientifically valid specifications for identity, purity, strength or composition as such analyses does not provide information about what is actually contained in the finished batch of product. We also note that though you conduct testing for microbiological, heavy metal and pesticide residues for all of your products, such testing would only satisfy the requirement to control contaminants that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement. Such testing does not satisfy the requirement that each finished batch of dietary supplements must meet product specifications for identity, purity, strength and composition as required by 111.70(e). Additionally, your On-Site Product Testing, SOP QA-003 Rev 03, fails to have a standard of how you will set a specification and how you will determine the strength of the product.
2. Your firm failed to establish a specification for the purity of incoming components necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). We have evaluated your Raw Material Receiving, SOP MAT-002 RV 02, and determined that it does not specify how to determine the purity of the materials you intend to use in manufacturing your products.
For example, in your March 25, 2015, response, you provided several examples of completed "Raw Material Receiving Checklist" for materials used in the production of Coptis batch #1225. The Checklist for these materials, including Scutellaria, has requirements for the visual aspects of damage, labeling, discoloration, foreign objects (stones or plastic) and organic contamination (insects or fungus) but nothing which requires evaluation of the actual intended content of the component as required by 21 CFR 111.70(b)(2). Such examinations would not be able to determine, for instance, whether foreign plant matter contaminated the raw material.
3. Your firm failed to include complete information relating to the production and control of each batch of finished dietary supplements in the batch production record (BPR), as required by 21 CFR 111.255 and 21 CFR 111.260. In your response of March 25, 2015, you provided a revised executed BPR for Coptis batch # 1225. However, this BPR lacks the following information:
a. The 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 [21 CFR 111.260(c)]
b. A statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]
c. Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g), and [21 CFR 111.260(i)]
d. Documentation, at the time of performance, of the manufacture of the batch, including the initials of the persons performing each step and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)]. Specifically, such documentation is not provided during the addition of ingredients to every batch or during the extraction phase of the manufacturing process.
e. Documentation, at the time of performance, of packaging and labeling operations including the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels [21 CPR 111.260(k)(l)]. Specifically, your record has not documented the quantity of packaging and labels used.
Misbranded Dietary Supplements
Even if the aforementioned products were not unapproved new drugs, the following products, as dietary supplements, are misbranded as follows:
1. Your Chrysanthemum, Meta-Plus, Curcuma, Chinese Bitters, Fern-mate, GCG, and Coptis product labels are misbranded within the meaning of Section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a U.S. address or U.S. phone number through which the responsible person (as described in section 761 of the Act [21 U.S.C. 379aa-1]) may receive a report of a serious adverse event with such dietary supplement.
2. Your Chrysanthemum, Meta-Plus, Curcuma, Chinese Bitters, Fern-mate, GCG, and Coptis 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 in accordance with 21 CPR 101.36.
We acknowledge your October 1, 2014, e-mail response and the labels which were attached. It does not appear that these labels are currently in use. As such, we have the following comments regarding these labels: the presentation of the nutrition information on the labeling of your products does not comply with 21 CPR 101.36. For example:
• Your revised labels fail to present nutrition information on the nutrition label using the title "Supplement Facts" [21 CPR 101.36(e)].
• Your revised labels include two boxed ingredient listings, one for Herbal Ingredients and one for Liquid Ingredients. Two boxes are not allowed under 21 CPR 101.36.
3. Your Chrysanthemum, Meta-Plus, Curcuma, Chinese Bitters, Fern-mate, GCG, and Coptis products are misbranded within the meaning of section 403(q)(l)(A) of the Act [21 U.S.C. § 343 (q)(1)(A)] because the labels fail to declare the serving size in accordance with 21 CPR 101.9(b) and 21 CPR 101.12(b) Table 2.
4. Your Chrysanthemum, Meta-Plus, Curcuma, Chinese Bitters, Fern-mate, GCG, and Coptis products are misbranded within the meaning of section 403(q)(l)(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 in accordance with 21 CPR 101.36(b)(1)(ii).
5. Your Chrysanthemum, Meta-Plus, Curcuma, Chinese Bitters, Fern-mate, GCG, and Coptis products are misbranded within the meaning of sections 403(s)(2)(A) and 403(q)(5)(F) of the FD&C Act [21 U.S.C. §§ 343(s)(2)(A) and 343(q)(5)(F)] in that the labels fail to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36.
6. Your Chrysanthemum, Meta-Plus, Curcuma, Chinese Bitters, Fern-mate, GCG, and Coptis products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility and 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. As a manufacturer of dietary supplement and cosmetic products intended for export to the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act) and all applicable federal regulations.
In addition to the above violations, we also have the following comments:
• We note that in order to fully comply with the requirements of 21 CFR 111.210(h)(2), your MMRs for dietary supplement products must include written instructions for procedures for sampling and a cross-reference to procedures for test and examinations.
• We note that as cosmetics, your Prime Herbal Mouthwash and Mu Shang Aluminum Free Herbal Deodorant products declare the net quantity of contents in milliliters only and not in quart, pint, or fluid-ounce units, as appropriate, as required by 21 CFR 701.13(b).
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported products under Section 801(a) of the Act, 21 U.S.C. 381(a), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the current Good Manufacturing Practices for dietary supplements regulations (21 CFR 111) is Import Alert #54-14; Import Alerts specific to products that are not in compliance with labeling regulations (21 CFR 101) are Import Alerts #99-20 and #99-39, and an Import Alert specific to products that are unapproved new drugs promoted in the U.S. is Import Alert #66-41. These alerts can be found on FDA's web site at:
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j-31 (a)(2)(B)). For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
Please send your reply to Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, Office of Compliance, Division of Enforcement, Labeling and Dietary Supplement Compliance Branch (HFS-608), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A.
William A. Correll, Jr.
Offcie of Compliance
Center for Food Safety
and Applied Nutrition
Michael S. Wong
Prime Health Products
133 The West Mall, Unit 8
Toronto, Ontario, Canada M9C1C2