Los Angeles District
19701 Fairchild Road
Los Angeles, CA 92612

VIA UPS NEXT DAY AIR

WARNING LETTER
 
 
UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
April 17, 2017
WL # 24-17
Mr. Ulysses Angulo                                                                                      
BioStar Technology International, LLC
4443 W Sunset Blvd
Suite B
Los Angeles, CA 90027
 
Dear Mr. Angulo:                                                                                          
                                   
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet addresses www.biostarorganix.com, in March 2017 and has determined that you take orders there for the products: Angiostop, Asparagus Extract, Ashwagandha, Desbio Venus Fly Trap, Liver Chi, Kidney Chi, OliveLeaf Qi, Revivn, Safed Musli and Weight Less No 4. We have also reviewed your websites at the Internet addresses www.biostar-health.com and www.biostar-health.org, which link to your www.biostarorganix.com website where these products can be purchased directly. The claims on your websites establish that these 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 may 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 use as drugs include:
 
On the Ashwagandha product webpage, www.biostarorganix.com/nutritionsbestashwagandha100caps300mg:
On the Desbio, Venus Fly Trap product webpage, www.biostarorganix.com/desbio-venus-fly-trap-2-oz:
On the OliveLeafQi product webpage, www.biostarorganix.com/biostar-technology-olive-leaf-qi-40-1:
On the Safed Musli product webpage, www.biostarorganix.com/nutritionsbestsafedmusli60caps500mg:  
On the Weight Less No 4 product webpage, www.biostarorganix.com/bioimmersionincweightlessno4systemicbooster
On the webpage www.biostarorganix.com/chi-health-flyers and www.biostar-health.org/research-library/, you provide several health flyers for products sold on your website. Examples of some of the claims observed on your flyers that provide evidence your products are intended for use as drugs include the following:
 
On the Angiostop product flyer:
On the Asparagus Extract product flyer:
On the Liver Chi product flyer:
On the Kidney Chi product flyer:
On the Revivin product flyer:
On the webpages www.biostarorganix.com/chi-protocol and www.biostar-health.org/chi-protocol, you provide a table with various medical conditions and recommended products for sale on your website. Examples of some of these conditions and products include the following:
Your www.biostarorganix.com website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
On the Angiostop product webpage, www.biostarorganix.com/chisenterpriseangiostop120capsforangiogenesisrtkinhibition:
Moreover, the claims quoted above are supplemented by the meta tags used to bring consumers to your website through Internet searches. The meta tags include:
 
On the Angiostop product webpage, www.biostarorganix.com/chis-enterprise-angiostop-120-capsfor-angiogenesis-rtk-inhibition:
On the Desbio, Venus Fly Trap product webpage, www.biostarorganix.com/desbio-venus-fly-trap-2-oz:
On the Revivin product webpage, www.chis-enterprise-revivin-120-caps/:
Finally, claims made on your Facebook page, www.facebook.com/BioStarOrganix, which has links to your website at www.biostarorganix.com where your products can be purchased directly, provide further evidence that your products are intended for use as drugs:
 
On your April 6, 2015 post:
On your August 24, 2012 post:
Your Angiostop, Asparagus Extract, Ashwagandha, Desbio Venus Fly Trap, Liver Chi, Kidney Chi, OliveLeaf Qi, Revivn, Safed Musli and Weight Less No 4. products are not generally recognized as safe and effective for the conditions, prescribed, recommended, or suggested in the labeling thereof and, therefore, these 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 the 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 Angiostop, Asparagus Extract, Ashwagandha, Desbio Venus Fly Trap, Liver Chi, Kidney Chi, OliveLeaf Qi, Revivn, Safed Musli and Weight Less No 4. 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, your Angiostop, Asparagus Extract, Ashwagandha, Desbio Venus Fly Trap, Liver Chi, Kidney Chi, OliveLeaf Qi, Revivn, Safed Musli and Weight Less No 4. do not bear adequate directions for their intended use and, therefore, 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)].
 
The above violations are not meant to be an all-inclusive list of violations in connection with your products or their labeling. It is your responsibility to ensure that your products and labeling comply with the Act and its implementing regulations. 
 
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 your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and the date by which you will complete the corrections.
 
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA.
 
Your response should be sent to:
 
Kelly D. Sheppard, Director
Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
 
 
If you have questions about this letter, please contact Ms. Sara Dent Acosta via email at sara.dent@fda.hhs.gov or by phone at (619) 941-3767.
 
Please reference CMS number 512757 in your response.
 
 
Sincerely,
/S/
CDR Steven E. Porter, Jr., Director
Los Angeles District
 
 
Cc:       David Mazerra, Ph.D.
            Chief, Food and Drug Branch
            California Department of Public Health
            1500 Capitol Avenue - MS 7602
            P.O. Box 997413
            Sacramento, California 95899-7435
 

This page was posted on July 17, 2017.

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