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WARNING LETTER

 

 

 

UNITED PARCEL SERVICE

SIGNATURE REQUIRED

 

May 15, 2019

WL#574615

Xuelin (Sheldon) Li, Chairman/Co-Owner

ActiveHerb Technology, Inc.

8830 Rehco Rd., Ste. E

San Diego, CA 92121-3263

 

Dear Mr. Li:

 

The United States Food and Drug Administration (FDA) inspected your facility located at 8830 Rehco Rd., Ste. E, San Diego, CA from September 11 - 17, 2018, and on March 19, 2019. During the inspection we collected labeling for your products. Based on a subsequent review of your product labeling, including labeling collected during the inspection as well as your website at the internet address www.activeherb.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

 

Unapproved New Drugs

 

Following the September 2018 inspection, FDA reviewed labeling collected during the inspection, including product labels and a product catalog.  FDA also reviewed your website at the internet address https://www.activeherb.com in March 2019 and has determined that you take orders there for your Active Herb brand products YinVive, EaseTonic, and LiverVive, and your Guang Ci Tang brand products Vertigoff (Ban Xia Bai Zhu Tian Ma Pian), Nasopass (Bi Yan Pian), NeuroSoothe (Chai Hu Long Gu Lu Mu Li Pian (Wan)), JointsJoy (Du Huo Ji Sheng Wan), Cardiovigor (Fu Fang Dan Shen Pian), Kudzu Relaxe (Ge Gen Tang Pian), Stomacare (Huo Xiang Zheng Qi Pian), Breathmooth (Ke Chuan Pian), Stonepass (Li Shui Pai Shi Pian), and Bupleuri Relaxe (Xiao Chai Hu Pian (Wan)). The claims on your website and other labeling 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 labeling claims that provide evidence that your products are intended for use as drugs include:

 

EaseTonic

 

Product webpage:

• “You will feel happier without having to rely on taking a ‘little blue pill’ that may potentially cause side effects.  If you feel . . . depressed, or prone to mood swings, EaseTonic may help.”

In your 2017 Active Herb Product Catalog, which you stated you continue to distribute:

• “EaseTonic is based on one of the most well-known traditional Chinese medicine (TCM) formulas, Xiao Yao San, which has been studied extensively in clinicals trails against placebo, antidepressants, or in combination with antidepressants.  The collective results of the numerous studies show Xiao Yao San has beneficial effects on patients with depression, either using the formula alone, or combining with antidepressants.”

LiverVive

 

Product webpage:

• “In a clinical study, a Chinese herbal formula that is a variation to LiverVive was used to treat 50 chronic hepatitis B patients.  After 3 months of treatment, 20 patients were fully recovered, 28 were significantly improved . . . the effective rate is much higher than that of the control group in which the standard treatment was applied.”
• “Si Jun Zi Tang, a building formula of LiverVive, demonstrated the ability to prevent liver damage after intervention of liver cancer, compared to a control group given western medicine.” 
• “Si Ni San, yet another building formula of LiverVive, showed anti-liver injury effects . . .”

Product Catalog:

• “Continuous inflammation of the liver may gradually cause liver fibrosis and scars, resulting in cirrhosis and, sometimes, liver cancer. LiverVive provides the nutritional help your Liver needs to maintain normal function . . . LiverVive may protect the liver from damage and enhance the immune function of the body for the clearance of viruses that are harmful to normal liver function.  Research supports LiverVive’s efficacy as a herbal remedy for chronic hepatitis B patients.” 
• “Hepatitis Remedies”

YinVive

 

On the product label: “This time-tested formula may . . . relieve lower back pain.”

 

Vertigoff (Ban Xia Bai Zhu Tian Ma Pian)

 

Product webpage:

• “Related topics . . . Vertigo Headache”

Product Catalog:

• “This formula is used for the TCM syndrome that includes vertigo, nausea, frequent headaches, and epilepsy”
• “Related concerns: Epilepsy . . . Vertigo . . . Headache”

Nasopass (Bi Yan Pian)

 

Product webpage:

• “It is commonly recommended herbal remedy in China for relieving symptoms such as nasal congestion, and stuffy nose with phlegm” 
• “Related concerns . . . Rhinitis”
• “Bi Yan Pian . . . work(s) in several different ways to help relieve nasal congestion . . . it dissolves phlegm (especially nasal mucous), clears discharge and thus opens the nasal passages”
• “Bi Yan Pian works most effectively with acute occurrence of nasal congestion . . . It takes longer for chronic nasal congestion.”

Product catalog:

• “a Chinese herbal medicine particularly formulated for rhinitis . . . to help relieve rhinitis and sinusitis symptoms . . . “

NeuroSoothe (Chai Hu Long Gu Mu Li Pian)

 

Product webpage:

• “Related topics . . . Withdrawal Support”

• “[T]he applications of this formula have expanded to include many disorders . . . [including] irregular heartbeat and mental disturbance . . . .”

Product catalog:

• “used . . . to calm . . . anxiety, help insomnia, palpitations”
• “This herbal remedy may also be used in some cases of schizophrenia, epilepsy, bipolar disorder, and drug withdrawal . . . .”
• “Related Concerns: Anxiety . . . Epilepsy . . . Withdrawal”

JointsJoy (Du Huo Sheng Pian (Wan))

 

Product webpage:

•  “shown to inhibit inflammation reactions and to inhibit pain”
• “In one study, 41 patients with a history of arthritis (rheumatic or rheumatoid) . . . were treated, 7 were recovered, 21 showed significant improvement, 10 showed some improvement . . . In another trial, 52 patients with the same condition were treated with Du Huo Ji Sheng Wan for 2 to 3 months, 35 showed significant improvement”

Product catalog:

• “a Chinese herbal remedy . . . to alleviate pains . . . used for rheumatic arthritis, rheumatoid arthritis, rheumatic back pain, sciatica, etc”

Cardiovigor (Fu Fang Dan Shen Pian)

 

Product webpage:

•  “relieves pain”
• “has antiplatelet action”

Product catalog:

• “used in China to alleviate heart-related pain like angina pectoris, palpitations, shortness of breath”
• “Related concerns: Angina . . . palpitation”

Kudzu Relaxe (Ge Gen Tang Pian)

 

Product webpage:

•  “Effective for cluster headaches”
• “Related topics . . . Cold & Flu Remedies . . . headache”
• “relieve muscle aches”
• “relieve pain”
• “study found that various Kudzu preparations may cut the frequency, severity, and duration of cluster headache”

Product catalog:

• “invented 1800 years ago for the common cold and headache . . . effective for cluster headaches”
• “Related concerns . . . Cold & Flu Remedies . . . Headache”

Stomacare (Huo Xiang Zheng Qi Pian)

 

Product webpage:

•  “Related topics . . . heat stroke . . . stomach flu . . . diarrhea”
• “nausea, vomiting, watery stool . . . stomach flu . . . heat stroke . . Huo Xiang Zheng Qi Pian . . . addresses the above disorders. It has properties that separately take care of the aspect of common colds and that of gastrointestinal discomfort”

Product catalog:

• “recommended by doctors for stomach flu, summer colds, and heat stroke”
• “Related concerns . . . heat stroke . . . stomach flu . . . diarrhea”

Breathmooth (Ke Chuan Pian)

 

Product webpage:

•  “formulated to help open the airways and breathe smoothly in cases of mild coughing and wheezing”

Product catalog:

• “specially formulated for cough, asthma, and obstructive phlegm”
• “Related concerns . . . Asthma Remedies . . . Cough & Phlegm”

Stonepass (Li Shui Pai Shi Pian)

 

Product webpage:

• The herbs in Stonepass . . .  unblock painful urinary dribbling and push out deposits.”
• “Jin Qian Cao (Gold Coin Grass, aka Asian Moneywort) the chief herb in Stonepass, is perhaps the most well known Chinese herb for promoting urination and expelling stones. It . . . reduces swelling.”
• “The chief herb in the formula, Jin Qian Cao . . . reduces stone formation of pure calcium oxalate crystals”

Product catalog:

• “may help pass kidney stones”
• “Related Concerns: Kidney Stone”

Bupleuri Relaxe (Xiao Chai Hu Pian (Wan))

 

Product catalog:

• “has . . . broad applications . . . the common cold, jaundice, hepatitis”
•  “Related concerns . . . Hepatitis Remedies”

Your 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 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 EaseTonic, LiverVive, Vertigoff, NeuroSoothe, Cardiovigor, Stonepass, and Bupleuri Relaxe products 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 safety for their intended purposes. Accordingly, your EaseTonic, LiverVive, Vertigoff, NeuroSoothe, Cardiovigor, Stonepass, and Bupleuri Relaxe 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)].

 

Misbranded Dietary Supplements

 

FDA also reviewed several product labels collected during the inspection and notes significant label deviations, as follows:

 

1.  Your Guang Ci Tang brand products Cold Signoff, NeuroSoothe, Skin Windclear, Tumoclear, and Spiritcalm, and your ActiveHerb brand products YinVive and QiVive 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 in English 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). Furthermore, if all components of a plant are used as a dietary ingredient, the Supplement Facts label must declare “whole plant,” “entire plant,” or a similar descriptor. Finally, the term “herb” is not a plant part.

 

2.  Your Active Herb brand Yin Vive and QiVive products are misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the labels is incorrect.  The serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The YinVive and QiVive labels’ Suggested Use directs to take up to 4 capsules at a time, but the Serving Size listed in the Supplement Facts labels is two capsules.

 

3.  Your Guang Ci Tang brand products Cold Signoff, NeuroSoothe, Skin WindClear, Tumoclear, and SpiritCalm, and your Active Herb brand products Yin Vive and QiVive products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that product labels fail to include ingredients that are not dietary ingredients or that do not contain dietary ingredients, such as excipients, fillers, artificial colors, artificial sweeteners, flavors, or binders. In addition, the product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example:

 

a.  The YinVive and QiVive products are encapsulated, but the capsule ingredients are not declared in the ingredient statement.

b.  If a botanical ingredient is listed in Herbs of Commerce, the standardized common name must be listed on the Supplement Facts label. Your Guang Ci Tang brand Cold Signoff lists “Platycodi Grandiflori”, however the standardized common name for this plant as noted in Herbs of Commerce is “Platycodon.” Likewise, your Guang Ci Tang brand Neurosoothe product label lists “Radix Ginseng.” Ginseng is not the complete standardized common name for a plant.

c.  Terms such as “Concha Ostreae,” “Os Draconis”, “Periostracum Cicadae, and “Gypsum Fibrosum” are not common or usual names for dietary ingredients.

d.  Terms such as “Rhei”, “Paridis”, “Sarcandrae”, “Dogwood”, Albiziae”, “Citrus Peel” are not common or usual names for dietary ingredients.

 

4.  Your Guang Ci Tang brand products Cold Signoff, NeuroSoothe, Skin Windclear, Tumoclear, and Spiritcalm products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contain information in two languages but do not repeat all the required information in both languages. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. These products include foreign language on the labels but fail to list the “Herbal Dietary Supplement” part of the statement of identity, net quantity of contents, all information in the Supplement Facts label including Supplement Facts, Serving size, servings per container, and so on, and the name and address of the responsible party.

 

5.  Your ActiveHerb brand YinVive product label is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

 

The violations cited in this letter are not intended to be an all-inclusive statement of 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 you’re your firm complies with all requirements of federal law, including FDA regulations. 

 

You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

 

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation, such as photographs, corrective actions taken to date, or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 

 

Your written response should be directed to:

 

Sergio Chavez, Director Compliance Branch

Food and Drug Administration

Office of Human and Animal Foods Division West 5

Los Angeles District Office

19701 Fairchild

Irvine, CA 92612

                                                                                                                                                                                        

Refer to the Unique Identification Number CMS 574615 when replying.

 

If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at [email protected], or (949) 608-4496.

 

 

 

Sincerely,

/S/

Melanie Mayor, acting Program Division Director

Office of Human and Animal Foods

Division 5 West

US Food and Drug Administration

 

 

cc:       Benson Yee

            Chief, Food and Drug Branch

            California Department of Public Health

            1500 Capitol Avenue - MS 7602

            P.O. Box 997413

            Sacramento, California 95899-7435