Los Angeles District
VIA UPS NEXT DAY AIR
UNITED PARCEL SERVICE
April 17, 2017
WL # 24-17
Mr. Ulysses Angulo
BioStar Technology International, LLC
4443 W Sunset Blvd
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:
- “used in folk medicine against arthritis, asthma, cancer … hypertension … psoriasis, rheumatism, ringworm, scabies, senility small pox … syphilis, tuberculosis, tumors, typhoid”
- “Ashwagandha also used in diabetes”
- “relieves … hypertension”
- “decrease high cholesterol levels”
On the Desbio, Venus Fly Trap product webpage, www.biostarorganix.com/desbio-venus-fly-trap-2-oz:
- “treatment of rheumatoid arthritis, ulcers, anemia … natural antibiotic and anti-anaphylactic properties.”
- “arthritis, bacterial infection, bronchitis, fever, flu, gangrene, gonorrhea, hepatitis, herpes, kidney infections, lung infections, strep throat, viral infections … ulcers”
On the OliveLeafQi product webpage, www.biostarorganix.com/biostar-technology-olive-leaf-qi-40-1:
- “cancers with the lowest incidence were prostate and colon cancers.”
- “antifungal properties … anti-infllamatory [sic] properties, its antibiotic properties … lower blood pressure”
- “Natural pathogens killer: It kills pathogens by preventing pathogens from replicating … Flus… Heart Disease … Lowering Bad Cholesterol or Low Density Lipoproteins (LDL) … Lowers Blood Pressure … Treats Epstein-Barr Disease … Treats Shingles … Treats Herpes”
- “prevent development of diseases such as cancer and other diseases”
On the Safed Musli product webpage, www.biostarorganix.com/nutritionsbestsafedmusli60caps500mg:
- “curing impotency”
- “curing autoimmune related diabetes and arthritic conditions”
On the Weight Less No 4 product webpage, www.biostarorganix.com/bioimmersionincweightlessno4systemicbooster:
- “reduction of the risks of diabetes, obesity … reduces insulin levels and increases insulin sensitivity”
- “ …this combination induced a 48% lower post-meal blood sugar response than placebo and reduced the need for insulin by 12%”
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:
- “Section slice of sarcoma tumor in mice … shows the cells in the control group without apotosis and the Angiostop group with apoptosis (tumor died) …”
On the Asparagus Extract product flyer:
- “ASPARAGUS EXTRACT for HYPERTENSION”
- “Asparagus should be taken by everyone for heart, cancer prevention. Other benefits are to … heart arrhythmia.”
- “ASPARAGINASE … treatment for acute lymphocytic leukemia, chronic lymphocytic leukemia, acute myelomonocytic leukemia, acute myelocytic leukemia (AML), Hodgkin’s lymphoma and non-Hodgkin’s lymphoma.”
- “ASPARAGOSIDE … reduces breast, pancreatic, cervical cancer in mice … inhibits human cervical cancer cells and leukemia cancer cells in mice”
On the Liver Chi product flyer:
- “In 6 days, Hepatitis C Virus replication and expression will be suppressed … The virus stays intact inside the cells and can no longer infect normal liver cells. The virus will eventually die.”
On the Kidney Chi product flyer:
- “effective in inhibiting different types of bacteria, including E. coli, Staphylococcus aureus, Bacillus, and Streptococcus”
- “For LYME DISEASE, use Kidney Chi”
On the Revivin product flyer:
- “attacks cancer at the DNA level. This results in a more comprehensive cancer inhibition therapy.”
- “a 71 y/o/f from CA, had colorectal cancer in 2001 that spread to her pancreas and liver. Her doctors had given up on her. She has been on Angiostop, Revivin … etc., since May 2002. Now 6 years later, she’s cancer-free”
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:
- “Arthritis (Rheumatoid) … Autocin, Myosteo … Angiostop, Bathdetox”
- “Breast Cancer … Angiostop, Myomin … Revivin, Reishi Spore, Asparagus Extract”
- “Bronchitis … OxyPower, Cordyceps Extract … Bamboo Extract, Reishi Spore Extract, Synergen, Chi Energy”
- “Cancer … Angiostop, Revivin, Reishi Spore Extract, Asparagus Extract … Myomin is added for hormone-related cancers”
- “Coronary Heart Disease … Vein Lite, OxyPower, Asparagus Extract … Chi Energy, CoQ10, Metal Flush, Reishi Spore”
- “Diabetes … Diabend, OxyPower, Myomin … Digestron, Cordyceps Extract, Wine Extract”
- “Parkinson’s Disease … Vein Lite, Asparagus Extract”
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:
- “66-year-old male patient with an inoperable fatty tumor on the brain stem the size of a golf ball. He recommended Angiostop, Revivin, etc. Six months later, his MRI does not show that tumor.”
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:
- “used it in the treatment of certain cancers and stomach ulcers … cuts off the blood supply to cancer cells .. basal cell carcinoma, breast cancer, cervical dysplasia, colorectal, keratosis, leukemia, lung, lymphoma, macular degeneration … melanoma, ovarian, polyps, prostate … treatment of certain cancers and stomach ulcers”
On the Desbio, Venus Fly Trap product webpage, www.biostarorganix.com/desbio-venus-fly-trap-2-oz:
- “arthritis, bacterial infection, bronchitis, fever, flu, gangrene, gonorrhea, hepatitis, herpes, kidney infections, lung infections, strep throat, viral infections, sinusitis, ulcers”
On the Revivin product webpage, www.chis-enterprise-revivin-120-caps/:
- “natural alternative for patients diagnosed with carcinogenic tumors … help people diagnosed with liver, breast and colon cancer … malignant growths, tumor, fibroid … melanoma”
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:
- “Wine Extract can be combined with Vein Lite and Oxypower to help reduce risk for cardiovascular disease.”
- “help manage cancer, Angiostop, Revivin, Reishi Spore Extract and Asparagus Extract are recommended”
On your August 24, 2012 post:
- “Angiostop will help stop tumor growth and induce apoptosis.”
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
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have questions about this letter, please contact Ms. Sara Dent Acosta via email at firstname.lastname@example.org or by phone at (619) 941-3767.
Please reference CMS number 512757 in your response.
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.