Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/herbs-america-inc-545913-04182018
Timestamp: 2020-07-09 16:01:30
Document Index: 247392626

Matched Legal Cases: ['§ 321', '§ 321', '§ 331', '§ 352', '§ 353', '§ 352', '§ 331']

Herbs America, Inc. - 545913 - 04/18/2018 | FDA
Herbs America, Inc. - 545913 - 04/18/2018
Herbs America, Inc. MARCS-CMS 545913 — April 18, 2018
Herbs America, Inc.
22215 261h Avenue SE, Suite 210
In reply, refer to: WL CMS 545913
Jerome R. Black, President
Murphy, Oregon 97533
This is to advise you that the United States Food and Drug Administration (FDA or we) reviewed your website at the internet address https://herbs-america.com in April 2018 and has determined that you take orders there for the products Chanca Piedra, Jatoba, Boldo, Copaiba oil, Chu Chu Huasi, and Maca (Lepidium meyeneii) products. We also reviewed your websites www.chuchuhuasi.com, www.lepidium.com and http://chanca-piedra.com which promote your products and contain links to https://herbs-america.com where the products can be purchased. We also reviewed your Maca Magic store on www.amazon.com.
The claims on your websites establish that the Chanca Piedra, Jatoba, Boldo, Copaiba oil, Chu Chu Huasi, and Maca (Lepidium meyeneii) products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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.
Examples of some of the website claims that provide evidence that your products are intended for uses as drugs include:
On the webpage https://herbs-america.com/product/chanca-piedra/ under the Description tab for Amazon Therapeutics Stone Breaker Chanca Piedra:
“Generations of Amazonian natives have used Chanca Piedra for its purported use . . . to assist in avoiding such issues as gallstones and kidney stones.”
“[B]y aiding the detoxification efforts that purge harmful substances.”
“It also shows antispasmodic effects.”
On your webpage, http://chanca-piedra.com/, which contains a link to http://herbs-america.com where the product can be purchased:
“A supplement . . . aiding its [the liver’s] detoxification efforts to purge harmful substances.”
“Chanca piedra has been evaluated for antioxidant activity and its response to high blood pressure and high blood sugar.”
On your Maca Magic store on www.amazon.com under “Customer questions & answers”:
“This product helps to break down the stones so that you can pass them.”
Your websites also contain evidence of intended use in the form of personal testimonials recommending or describing the use of Chanca Piedra for the cure, mitigation, treatment, or prevention of disease. An example of such testimonials include:
On the webpage https://herbs-america.com/product/chanca-piedra/ under the Reviews tab for Amazon Therapeutics Stone Breaker Chanca Piedra:
“My husband has been using this for years after a surgical procedeure [sic] to remove kidney stones. Since using this at the first sign of pain, he has passed every one. This breaks up the stones and softens them so they pass.”
And your Maca Magic store on www.amazon.com under “Top customer reviews”:
“I’m using this product to relieve gallbladder pain and to break down the stones...”
“This stuff is a must if you have kidney stones . . . I found this one and it successfully broke up his kidney stones so he could pass them.”
Jatoba Cut & Sift bulk herb
On the webpage https://herbs-america.com/product/jatoba-hymenaea-courbaril-cut-sift-kosher-1-pound under the Description tab:
“The bark has been used by many tribes to treat everything from diarrhea … internal parasites, stomach issues, coughs and nail fungus!”
“The first recorded medicinal use was in Brazil in 1930 by Dr. J. Monteiro Silva. He recommended using the bark for diarrhea, dysentery … dyspepsia, hematuria, bladder problems, and hemoptysis.”
Boldo Whole Leaf bulk herb
On the webpage https://herbs-america.com/product/boldo-peumus-boldus-cut-sift-1-pound/ under the Description tab:
“A famed herb in the Andes mountains of Chile and Peru, Bold [sic] has traditionally been considered a strong bitter tonic and used by the natives of South America in the treatment of digestive disorders. The German Commission E has approved boldo leaf as an herbal drug that allows use for complaints of the gastrointestinal tract including dyspepsia (indigestion).”
On the webpage https://herbs-america.com/product/copaiba-oil-1oz/ under the Description tab for Amazon Therapeutics Copaiba:
“It has popularly been mixed with water or added to honey and used as a gargle for sore throats.”
On the product page on your Maca Magic store on www.amazon.com under “Product description”:
“Internally it has been used as an antiseptic and expectorant for the respiratory tract as well as an anti-inflammatory and antiseptic for the urinary tract.”
Chu Chu Huasi bulk herb
On your webpage, www.chuchuhuasi.com, which contains a link to https://herbs-america.com where the product can be purchased:
“Chuchuhuasi is most commonly used to treat rheumatism, tuberculosis, bronchitis, stomach ache, and fever . . .”
“Chewing Chuchuhuasi bark is considered by some to be effective in treating diarrhea, arthritis . . . and upset stomach.”
“Its anti-inflammatory and analgesic properties are taken advantage of in relieving rheumatic conditions.”
“Chuchuhuasi also helps some in their fight against pain due to its analgesic properties. It is an anti-inflammatory, anti-arthritic, and valuable to some in the treatment of Parkinson’s disease, MS and alcoholism.”
“The Quijos Quichua Indians use a decoction of chuchuhuasi for rheumatism, aching muscles, menstrual aches, stomach aches, and general aching.”
Maca Magic products
On your webpage, www.lepidium.com/, which contains a link to https://herbs-america.com where the products can be purchased, such as your Maca Magic Organic Raw Maca Powder:
“Maca Root [the ingredient in the product] is credited by many with possessing immuno-stimulating qualities that help to build the body's defenses against invasive infection and serious disease.”
“Because Maca is thought to balance hormonal activity, it is believed to be useful in cases of sterility and other reproductive and sexual disorders. In men, it is believed to treat male impotence and erectile dysfunction . . .”
“There are current studies claiming that the glucosinolates found in Maca Root may help to combat serious invasive infection; they are the substances that are also found in other members of the Brassicaceae family (including broccoli, cabbage, cauliflower and other cruciferous vegetables) and are said to be particularly effective in building the body's defenses against serious malignant illnesses.”
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, Title 21 Code of Federal Regulations 201.5 (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 Chanca Piedra, Chu Chu Huasi, and Maca (Lepidium meyeneii) 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 safely for their intended purposes. Accordingly, Chanca Piedra, Chu Chu Huasi, and Maca (Lepidium meyeneii) fail to bear adequate directions for their intended use and, therefore, the products are misbranded within the meaning of 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)].
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
Please notify this office in writing, within fifteen (15) working 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 from recurring or other similar violations from occurring. You should include documentation of corrective actions you have taken to date. If your firm will not be able to complete corrective actions before you respond, please state the reason for the delay and include a timetable for implementation of those corrections.
Your written response should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of LCDR Cynthia White, Compliance Officer. If you have additional questions, please contact LCDR White at 425-302-0422.
cc: Jerome R. Black
Island Herb and Spice
635 Capital Street NE