Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty AvenueJamaica, NY 11433
October 9, 2014
WARNING LETTER NYK-2015-3
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Felix Ramirez
Bethel Nutritional Consulting, Inc.
599 West 190th Street, Suite 1
New York, NY 10040
Dear Mr. Ramirez:
This is to advise you that in June 2013 and September 2014 the U.S. Food and Drug Administration (FDA or we) reviewed your website at www.bethel30.com and has determined that you take orders there for the products 15 Day Detox Diet, Alpha Lipoic Acid. 300 mg. Capsules, Black Cohosh, B Thinner, Carbo-Fat, Cascara sagrada, Cholest Away, Dong Quai, Eagle Eye, Garlic and Parsley, Ginseng Extract, Lecithin, Omega Max EPA, Potassium, Saw Palmetto, St. John’s Wort, Sweet Sleep, Ultimate B Burner, Valerian Root, Women Plus, and Yohimbe, which the website promotes for conditions that cause the products to be drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs 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 FD&C 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 claims that provide evidence that your products are intended for use as drugs include, but are not limited to, the following:
15 Day Detox Diet
● “It may reduce inflamation and preventing [sic] atherosclerosis”
Alpha Lipoic Acid. 300 mg. Capsules
● “[A]ssist with preventing Alzheimer’s disease as well as stroke, and removing mercury from braintissue.”
● “[A]ssist with liver disorders, such as chronic hepatitis and protecting the liver cells from damage.”
● “Black Cohosh… is now a popular alternative to hormone replacement therapy (HRT). Native Americans were the first to use the Black Cohosh root as a helping herb for malaria, rheumatism…colds…hives… Modern research has shown that Black Cohosh treats… depression and…Black Cohosh… serves as a mild anti-inflammatory. Research has also shown that Black Cohosh is a mild sedative and decongestant.”
● “Assist in helping combat …obesity.”
● “Assist in lowering triglycerides and bad cholesterol”
● “Asssist in controlling blood sugar levels in people with type 1 and type 2 diabetes”
● “Recommended for…treatment of intestinal parasites and colitis”
● “Lowers cholesterol levels as effectively as statins without the side effects. Red Yeast Rice Increases HDL levels and also lowers elevated serum triglyceride levels. Use in conjunction with CO-Q10 for difficult cholesterol.”
● “May help in lower elevated blood pressure”
● “Assist in preventing thrombosis and cerebrovascular diseases”
● “[P]rotecting against age-related macular degeneration (ARMD) and age-related cataract formation.”
Garlic and Parsley
● “May reduce the risk of heart attacks by lowering levels of homocysteine”
● “Assist reducing blood clots”
● “May help prevent atherosclerosis, adrenal insufficiency …anemia, cancer, chronic illness, depression and diabetes.”
● “[I]t contributes to prevent the accumulation of cholesterol and other fats in the walls of arteries, and can help in addition to dissolve the fat that is deposited.”
Omega Max EPA
● “Helps lower the risk of heart attack, stroke and cardiac arrhythmias”
● “Helps reduce high blood pressure and inflammatory diseases such as rheumatoid arthritis
●“Regulating blood pressure, protecting against hypertension, strokes, cardiovascular disease.”
● “[R]educing colds…asthma, chronic bronchitis, migraines and cancer.”
St. John’s Wort
● “The St. John's Wort has been used for centuries by its great benefits in the treatment of the nervous system, especially in depressive disorders and anxiety…St. John's Wort has been used in the helping …hemorrhoids and insomnia.”
● “May act as…, antipyretic, antibacterial, antifungal, and antiallergenic”
● “May help reduce asthma, colic, fevers, inflammations…
● “Normalize the levels of blood sugar.”
● “May help with…irritable bowel syndrome”
● “May help reduce the high blood pressure, the pain, the spasms and muscle cramps disorders of attention deficit hyperactivity (ADHD/ADHD)”
● “It … may help in the use for … menstrual irregularities, … and reducing inflammation associated with osteoarthritis, rheumatoid arthritis and neuralgia.”
● “May assist in sexual dysfunction, including erectile dysfunction”
Your 15 Day Detox Diet, Alpha Lipoic Acid. 300 mg. Capsules, Black Cohosh, B Thinner, Carbo-Fat, Cascara sagrada, Cholest Away, Dong Quai, Eagle Eye, Garlic and Parsley, Ginseng Extract, Lecithin, Omega Max EPA, Potassium, Saw Palmetto, St. John’s Wort, Sweet Sleep, Ultimate B Burner, Valerian Root, Women Plus, and Yohimbe are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. Under sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of these products without such approved applications violates these provisions of the Act.
These products are prescription drugs as defined in section 503(b)(1)(A) of the Act (21 U.S.C. § 353(b)(1)(A)) because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, the products are not safe for use except under the supervision of a practitioner licensed by law to administer them.
According to section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)), a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely, and for the purposes for which it’s intended (21 CFR § 201.5). Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 CFR § § 201.100(c)(2) and 201.115). Because there is no FDA-approved application for your products, its labeling fails to bear adequate directions for its intended use, causing it to be 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 products violates section 301(a) of the Act (21 U.S.C. § 331(a)).
Although some of the claims described in this section were discussed with your firm in June 2013, no corrective action was noted when we reviewed your website again in September 2014.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations noted above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In particular, to the extent you manufacture, package, label, or hold dietary supplements, you are subject to all applicable requirements in 21 CFR part 111 relating to your operations for the manufacture, packaging, labeling, and holding of dietary supplements.
You should take prompt action to correct all of 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. If you cannot complete corrective action within fifteen working days, state the reason for your delay and the time within which you will complete the correction.
Your written response should be sent the Food and Drug Administration, attention:
Lillian C. Aveta
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4052
Jamaica, NY 11433
If you have any questions about the content of this letter please contact: Compliance Officer Aveta at (718) 662-5576.
Ronald M. Pace
New York District