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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sami A. Yanikian M.D. 17-Mar-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, CA 92612-2506
Telephone (949) 608-2900



WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REOUESTED



March 17, 2005

W/L 12-05

Dr. Sami A.Yanikian
1117 S. Bronson Ave. #1
Los Angeles, CA 90019

Dear Dr. Yanikian:

This letter concerns your firm's marketing and sale of the products, "Novel natural formulation for atrial fibrillation," "Super Nasal Drops," and "Sams [sic] No Tinnitus Formulation." According to information on your website, www,geocities.com/atfibrillation/, your formulation for atrial fibrillation is marketed as an oral anti-arrhythmic, anti-anginal, and a substitute for angioplasty and coronary bypass surgery; Super Nasal Drops is marketed to relieve, prevent, and immunize against all types of flu, cold and SARS viruses, and acute and chronic sinusitis; Sams No Tinnitus Formulation is marketed to help patients with Meniere's Disease and hearing improvement.

You state on your website that "Novel natural formulation for atrial fibrillation . . . will correct atrial fibrillation within five to ten days or longer accordingly. It has the potential to correct other arrhythmias as well." You also state that this product "has the potential to relieving [sic] anginal attacks, preventing [sic] heart attacks, in addition to obviating the need for angioplasty and coronary bypass surgery."

Your website states that "Natural Super Nasal Drops . . . has the potential to reverse and relief [sic] all types of nasal allergy, such as seasonal and perennial allergic rhinitis, postnasal drip, chronic and acute sinusitis, hay fever, molds, in addition to pollens and animal dander. It relieves, prevents, immunizes against all types of flu, cold and SARS viruses. It is also helpful in acute and chronic sinusitis due to viral, bacterial, and fungal infections or allergic reactions with congestion and headache." The site also claims that "[t]he same formulation in an inhaler spray form . . . will dramatically relief [sic] all types of asthma (status asthmaticus [sic]), and improve performance in elite athletes, with the potential to reverse, pneumonia, chronic bronchitis, COPD, cystic fibrosis, tuberculosis, and respiratory viral conditions as SARS, human avian flu, and other viral infections."

Regarding Sams [sicLNo Tinnitus Formulation, your site claims that it "reduces tinnitus within couple [sic] of minutes in addition to improving hearing. This same formulation will help patients with Meniere's disease as well." The above claims cause "Novel natural formulation for atrial fibrillation," "Super Nasal Drops," and "Sams [sic] No Tinnitus Formulation" to be "drugs" as defined by the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C.321(g), because they are intended to cure, mitigate, treat, or prevent disease. Moreover, these products are "new drugs," as defined by 21 U.S.C.321(p), because there is no evidence that they are generally recognized as safe and effective for their labeled uses. Under 21 U.S.C. 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. None of these three products has an approved application and their introduction or delivery for introduction into interstate commerce violates 21 U.S.C.331(d).

A description of the new drug approval process can be found on FDA's Internet Website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.

Furthermore, because these products are offered for conditions that are not amenable to self diagnosis and treatment, adequate directions cannot be written so that a layman can use these products safely for their intended uses. All three products therefore lack adequate directions for their intended uses, causing them to be misbranded under 21 U.S.C. 352(f)(1).

The above violations are not intended to be an all-inclusive list of your business operation's deficiencies. It is your responsibility to ensure that the drug products you manufacture and/or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, we are prepared to take enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and/or distributor of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made.

Address your reply to the U.S . Food and Drug Administration, 19701 Fairchild, Irvine, CA 92612, Attention: John J. Stamp, Compliance Officer.

Sincerely,

/S/

Alonda E. Cruse
Director, Los Angeles District