WARNING LETTER
Madison One Acme Inc MARCS-CMS 523881 —
- Delivery Method:
- UPS
- Recipient:
-
Recipient NameMs. Wina Tran
- Madison One Acme Inc
215 W Ann St.
Los Angeles, CA 90012
United States
- Issuing Office:
- Los Angeles District Office
United States
Los Angeles District | |
WARNING LETTER
WL#34-17
VIA United Parcel Service
July 26, 2017
Ms. Wina Tran, CEO
Madison Once Acme, Inc. (dba Solstice Medicine Company)
215 W Ann St.
Los Angeles, CA 90012
Dear Ms. Tran:
On February 28, 2017, and March 21, 2017, the U.S. Food and Drug Administration (FDA or we) inspected your facility located at 215 W Ann St., Los Angeles, California. In addition, we have reviewed your website at the Internet address www.solsticemed.com. Based on our review, we have concluded that certain products are in violation of sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 355(a) and 352(f)(1)]. You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
Unapproved New Drug and Misbranded Drug Violations
The FDA reviewed your website at the Internet address www.solsticemed.com in May 2017, and has determined that you take orders there for your Sheng Fa capsules, Qing Chun Bao Anti-aging Oral Liquid, Ching Chun Bao Anti-aging tablets, Double Dragon Pill, Lien Chiao Pai Tu Pien tablets, Woo Garm Yeun pills, So Hup Yuen pills, Butiao tablets, Jian Bu Zhuang Gu Wan tablets, and Pe Min Kan Wan products. The claims on your website establish that these 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.
Examples of some of the claims on your website that provide evidence that your products are intended for use as drugs include:
- Sheng Fa capsules product web page:
o Declares to contain Dong Quai Root. Dong Quai Root claims noted on ingredient information web page:
• “Dong Quai is commonly used with other herbs as a remedy for disorders of the menstrual cycle like irregular menstruation…, menstrual cramps (also called dysmenorrhea), and excessive uterine bleeding. Traditional Chinese herbalists recommend Dong Quai for both males and females to treat disorders of the cardiovascular system like high blood pressure or circulation problems…”
• “It can also soothe the headaches…”
- Qing Chun Bao Anti-aging Oral Liquid product web page:
o Declares to contain Ginseng, declared as “Oriental Ginseng”. Ginseng claims noted on ingredient information web page:
• “Ginseng has a variety of effective medicinal uses; it can…decrease blood sugar levels…”
• “Ginse ng can…prevent headaches, fight insomnia….It has also been used to improve sexual dysfunction…”
- Ching Chun Bao Anti-aging tablets product web page:
o Declares to contain Ginseng, declared as “Oriental Ginseng”. Ginseng claims noted on ingredient information web page:
• “Ginseng has a variety of effective medicinal uses; it can…decrease blood sugar levels…”
• “Ginseng can…prevent headaches, fight insomnia….It has also been used to improve sexual dysfunction…”
- Double Dragon Pills product web page:
o Declares to contain Licorice Root. Licorice Root claims noted on ingredient information web page:
• “Some believe that it can remove intoxication from alcohol and drugs, though no scientific studies have confirmed this…”
• “Licorice is anti-inflammatory, antibacterial, antiviral, antioxidant and antispasmodic in nature…”
• “It is probably best known for it’s expectorant and demulcent activity. Licorice, for many years, has been an important ingredient in cough drops and syrup. Licorice, for many years, has been an important ingredient in cough drops and syrup. It’s also beneficial for treating cold, flu and sore throat and any illness caused by virus or bacteria…”
• “This root has so many healing properties it’s hard to list them all. Some others include the treatment of bronchitis, tooth decay, gingivitis, canker sores, ulcers, muscle cramps, enlarged prostate, dandruff, liver conditions, arthritis…”
- Lien Chiao Pai Tu Pien tablets product web page:
o Declares to contain Chinese Rhubarb. Chinese Rhubarb claims noted on ingredient information web page:
• “Rhubarb has been useful in treating jaundice and endometriosis. It can be used as an antibacterial agent to help treat health issues as varied as fevers, hypertension, toothaches, shingles, burns, acute appendicitis, acute infectious hepatitis, conjunctivitis, swelling of the gums, as well as sores on the mouth and tongue…”
- Woo Garm Yeun pills product web page:
o “Suffering from menstrual aches and cramps can be a very painful experience. This herbal supplement is a great product to help alleviate cramps...”
o Declares to contain cinnamon, Ginger as “Ginger Rhizome,” and Tangerine Peel as “Immature Tangerine Peel.”
- Cinnamon claims noted on ingredient information web page:
o “It has a mild anti-inflammatory effect. It has anti-fungal properties…”
- Ginger claims noted on ingredient information web page:
o “Ayurvedic medicine uses ginger to prevent heart disease and treat arthritis…”
o “[G]inger is an effective anti-inflammatory remedy that reduces the production of leukotrienes and prostaglandins. Ginger helps to stop coughing…”
- Tangerine Peel claims noted on ingredient information web page:
o “[C]ommonly used to treat indigestion…diarrhea, vomiting, and other forms of digestive illness or upset. It can break up congestion and help treat coughs involving excessive amounts of phlegm. It’s great for breaking up congestion….”
o “The peel of young green tangerines is called Qing Pi. It’s traditionally used to treat pain, especially in the side of the body and the breasts. It can also ease the discomfort from a hernia. The green peel has been used in the treatment of low blood pressure and, in combination with other herbs, can help treat breast inflammation…”
- So Hup Yuen pills product web page:
o Declares to contain Clove and Long Pepper as “Long Pepper Fruit Shake.”
o Clove claims noted on ingredient information web page:
o “Cloves are a natural antiviral, antiseptic, and anti-fungal agent…”
• “The oil of cloves has been used to treat a variety of health conditions including toothaches, headaches, indigestion, parasitic infestations, coughs…”
• “It's so effective that the scientists in Germany’s Commission E approved the use of clove’s essential oil as a topical antiseptic and anesthetic…”
- Long Pepper claims noted on ingredient information web page::
o “[U]sed to treat colds, coughs, and sore throats. Black pepper has traditionally been used to treat colic, cholera, headaches, toothaches, and skin diseases…”
o “It can help ease the symptoms of nicotine withdrawal and help stroke victims digest. Many modern herbalists recommend black pepper to…circulation, and treat health issues as varied as vertigo, arthritis…”
- Butiao Tablets product web page:
o Declares to contain Moghania Root. Moghania Root claims noted on ingredient information web page:
• “It can be used to help ease the pain from arthritis… and heal bruises…”
• “Moghania Root can be an effective way to treat musculoskeletal pain…It can also reduce tendon and bone pain. It has also been used to fight tonsillitis and hepatitis….”
- Jian Bu Zhuang Gu Wan product web page:
o “[H]elp to protect your liver from damage due to drugs and environmental problems. If the liver has too many toxins to deal with, this can lead to poor overall health…”
- Pe Min Kan Wan product web page:
o Declares to contain Fragrant Angelica as “Fragrant Angelica Root,” and Licorice Root
- Fragrant Angelica claims noted on ingredient information web page:
o “[U]sed to treat headaches, skin diseases like boils and carbuncles, and the facial pain caused by the nerve disorder trigeminal neuralgia…can ease high blood pressure, fight cardiovascular disease…”
o Declares to contain Licorice Root. Licorice Root claims noted on ingredient information web page:
• “Some believe that it can remove intoxication from alcohol and drugs, though no scientific studies have confirmed this…”
• “Licorice is anti-inflammatory, antibacterial, antiviral, antioxidant and antispasmodic in nature…”
• “It is probably best known for it’s expectorant and demulcent activity. Licorice, for many years, has been an important ingredient in cough drops and syrup. It’s also beneficial for treating cold, flu and sore throat and any illness caused by virus or bacteria…”
• “This root has so many healing properties it’s hard to list them all. Some others include the treatment of bronchitis, tooth decay, gingivitis, canker sores, ulcers, muscle cramps, enlarged prostate, dandruff, liver conditions, arthritis…”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products listed above 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 sections 301(d) and 505(a) of the Act [21 U.S.C. 331(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 Qing Chun Bao Anti-aging Oral Liquid, Ching Chun Bao Anti-aging tablets, Double Dragon Pill, Lien Chiao Pai Tu Pien tablets, Woo Garm Yeun pills, Butiao tablets, and Pe Min Kan Wan products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use 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)].
This letter is not an intended to be an all-inclusive list of violations at your facility or in connection with your products. It is your responsibility to ensure that your firm and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure or injunction.
We also offer the following comments about your dietary supplement products and the products noted above, even if the products noted above did not have therapeutic claims which make them unapproved and misbranded new drugs:
1. We note that you told our investigator that you receive finished packaged and labeled dietary supplements from manufacturers that manufacture dietary supplement products. You told our investigator that you hold your dietary supplement products in your warehouse and distribute them. At our inspection of your facility, your firm provided us with a document that describes the duties and responsibilities of your “quality unit.” Included in this description are responsibilities that include “approv[ing] product specifications” and “coordinat[ing] laboratory testing.” We also note that your firm’s logo, name, address, and phone number appear on your product labels. Additionally, it appears that, for certain products your firm purchases, you have responsibility for ensuring that the packaging and labeling fully conforms to relevant U.S. laws.
We have reviewed your responses dated March 8, 2017, March 21, 2017, and April 11, 2017. In your March 21, 2017, response, which is similar to your March 8, 2017, correspondence, you told us that your firm “(b)(4).” In your March 21, 2017, correspondence, you also told us that your firm (b)(4). The documentation provided with your April 11, 2017, response states that the firms that you (b)(4).
We note that, to the extent you receive products from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f). However, it appears that the operations you perform are not limited to the receipt of dietary supplement products from a supplier that you hold in your warehouse and distribute. For example, you identified certain labeling operations you perform and that you share product responsibilities through the identification of your firm’s name on the product label on the front of the package, in addition to identification as a distributor. You are responsible for complying with the applicable CGMP requirements related to the operations you perform, including the approval and release of product for distribution [see 72 Fed. Reg. 34752 at 34789-90 (June 25, 2007)].
We note that, to the extent that another firm manufactures, packages, and/or labels dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790]. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act).
In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation, at the time of performance, that quality control personnel performed the review and approval for release of any packaged and labeled dietary supplement for distribution [21 CFR 111.127(h); 21 CFR 111.140(b)(2)].
2. We note your Organic San Qi Capsule Herbal Supplement product declares total carbohydrates as “1.2g”. in="" accordance="" with="" 21="" cfr="" 101.9(c)(6)="" and="" 21="" cfr="" 101.36(b)(2),="" a="" statement="" of="" the="" number="" of="" grams="" of="" total="" carbohydrate="" in="" a="" serving="" is="" to="" be="" expressed="" to="" the="" nearest="" gram,="" except="" that="" if="" a="" serving="" contains="" less="" than="" 1="" gram,="" the="" statement="" "contains="" less="" than="" 1="" gram"="" or="" "less="" than="" 1="" gram"="" may="" be="" used="" as="" an="" alternative;="" if="" the="" serving="" contains="" less="" than="" 0.5="" gram="" carbohydrate,="" that="" amount="" is="" considered="" zero="" and="" may="" not="" be="" expressed.="">
3. Although your Yin Chiao Chiehtupien Herbal Supplement product declares the net quantity of contents as “96 Tablets” and “12-8 Tablets Vials,” the product also declares “0.6g” without any further description as to what the weight is referring to. We suggest the term be qualified; otherwise, its significance may be confusing to the consumer.
4. Your Organic San Qi Capsule Herbal Supplement product label bears the statement “Percent Daily Values are based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). None of those dietary ingredients is present on the label, so the statement is not permitted.
5. Your Organic San Qi Capsule Herbal Supplement and Yin Chiao Chiehtupien Herbal Supplement products each contain a supplement facts label, in which the placement of the heavy bar is not in accordance with 21 CFR 101.36(e)(6). The heavy bar shall be placed beneath the last (b)(2)-dietary ingredient to be listed, as well as beneath the last (b)(3)-dietary ingredient (other dietary ingredient) to be listed.
You should respond in writing within fifteen working days of your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to:
Daniel Solis, Director Import Operations Branch
U.S. Food & Drug Administration
One World Trade Center, Suite 300
Long Beach, CA 90831
If you have any questions about the content of this letter, please contact Compliance Officer David Serrano, at 562-256-9210 or david.serrano@fda.hhs.gov.
Sincerely,
/S/
CDR Steven E. Porter Jr.
Los Angeles District Director