|Company:||Alfa Vitamins Laboratories, Inc.|
|Subject:||New Drug/Labeling/False & Misleading Claims|
|Issuer:||Florida District Office|
|Issued:||July 12, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
July 12, 2012
Alfa Vitamins Laboratories, Inc.
1472 NW 78th Ave
Doral, FL 33126
Dear Mr. Valdes:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.alfavitaminsonlinestore.com and your online store at www.amazon.com in May 2012 and has determined that your Alfa's Sugar Control, Aloe Vera, Anamu and Llanten, CoQ-10, Diabetifen, Ginkgo Biloba Extract, MAX-EPA 2000 mg, Noni capsules, Noni Juice, Omega-3, Pulmonary Primacare, Shark Cartilage, Vitamin E, St. John's Wort, and Cat's Claw products are promoted for conditions that cause these products to be 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)]. The therapeutic claims in English and Spanish on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and FDA's regulations through links on FDA's home page at http://www.fda.gov .
Examples of some of the claims observed on your www.alfavitaminsonlinestore.com website for products that are recommended for certain diseases listed on your "Health Concerns" webpage include the following:
• Cat's Claw
• "May help alleviate viral and intestinal infections"
• "May help those who suffer [sic] AIDS, arthritis, rheumatism, diabetes, tumors, ulcers and cancers"
• St. John's Wort
• "Helpful for depression"
• "Could relieve viral infections"
• Ginkgo Biloba Extract
• "Could be helpful on asthma, kidney and heart disorders"
• "May improve depression, headaches ... "
• "Relieves Alzheimer and Reynaud's symptoms"
• Alfa's Sugar Control/Blood Sugar: The name of your product establishes the intended use of your product as a drug.
• "[A] formula developed for the regulation of blood sugar.".
• "It is recommended to patients with diabetes."
• "Helps stimulate the action of insulin controlling blood sugar levels"
• "Helps generate and rejuvenate pancreatic cells"
• "Gymnema [an ingredient in your product] has been successful in controlling the level of sugar in the blood without lowering it below normal."
• Diabetifen: Natural Remedies for Diabetes
• "This product has been formulated for those who suffer from diabetes."
• "It is a combination of ... Alfalfa and Ginkgo Biloba that traditionally have been used to ease the symptoms of diabetes."
• "Helps to alleviate the symptoms of diabetes"
• "Could help to regulate the insulin levels in our body"
• Shark Cartilage
• "Could relieve conditions like arthritis and psoriasis"
• "May be helpful in the treatment of macular degeneration and diabetic retinopathy"
• Anamu and Llanten
• "Anamu and Llanten as Anti Cancer Herbs ... "
• "Anamu has attributed anti-cancer, anti-inflamatory, anti-microbial properties ... "
• "Anamu ... help[s] us fight cancer."
• "The herb [Anamu] is used ... to treat colds, coughs, flu, lung infections and cancer ... "
• "[I]t [ anamu] has a wide range of therapeutic properties, including activities against several types of cancer ... "
• "Llanten is mostly acknowledged for its properties against respiratory diseases ... and ophthalmic (relieves conjunctivitis and other eye diseases)."
• "It is ... used against diarrhea and dysentery."
• "[H]elps heal anal fistulas."
• "Helps in treating diabetes."
• "Heals wounds."
• "Helps in treating colds, flu, cough"
• "Helpful in the treatment of cancer"
• "Helpful for diabetes"
• MAX-EPA 2000 mg
• "Ameliorates the risk of cardiovascular disease"
• "Contains anti-carcinogenic properties"
• "Reduces asthma"
• Noni capsules and Noni Juice
• "[R]egulator of...high blood pressure ... "
• "[H]elps alleviate problems of arthritis and swelling of the joints"
• "It is beneficial to ... diabetes, cancer, high blood pressure, tuberculosis and malaria"
• "It helps fight addictions such as alcohol and tobacco"
• Vitamin E 400 IU, Antioxidant Supplement
• "[R]elieves the swelling associated with arthritis, accelerate wound healing in people who have suffered burns or have had surgery, and slows the progress of Parkinson's and Alzheimer's."
• "It can delay the development of arteriosclerosis and Alzheimer's disease"
• "It is important in preventing cancer ... "
• "It can prevent diabetes"
• "It helps in preventing cataracts"
Examples of some of the claims observed on your www.alfavitaminsonlinestore.com website that are not for products listed on your "Health Concerns" webpage include the following:
• "[C]ould be helpful for asthma and allergies, candidiasis, diabetes and multiple sclerosis"
• "CoQ-10 is . . . used to treat cardiovascular diseases, including hypertension, diabetes ... and muscle dystrophy"
• "May reduce blood pressure and cholesterol"
• "Prevents arthritis"
• "Helpful in the treatment of candidiasis, eczemas, psoriasis and cardiovascular problems"
• "[C]ould be ... effective to recover from respiratory infection and diseases like the flu, bronchitis .... "
• "Could be beneficial for asthma, edema, polymyositis and other lung diseases"
Examples of claims found on your Amazon.com online "store" and www.alfavitaminsonlinestore.com website include the following:
• Aloe Vera
• "Very effective ... for ... eczema"
• "It may improve stomach disorders, ulcers ... hemorrhoids ... colitis"
• "Beneficial for infections ... skin cancer and arthritis"
• "It has helped in some treatments for AIDS."
• "[I]t owns antibacterial, antiviral and antifungal properties."
Furthermore, the claims quoted above are supplemented by the metatags you use to bring consumers to your web pages through Internet searches. Examples of some of the metatags include the following: "cholesterol lowering supplements," "herbs for high blood pressure," "reduce your blood pressure," diabetes relief," "diabetes," "blood sugar supplement to regulate insulin," and "anti-cancer herbs."
The claims listed above establish that your products are drugs, because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Based on these claims, such products are drugs within the meaning of section 201 (g)(1)(B) of the Act. 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 marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, because your products are offered for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purpose. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use.
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all of your products and labeling in all languages are in compliance with the laws and regulations enforced by FDA.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to promptly correct these violations may result in regulatory action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
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. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen working days, please explain the reason for the delay and state the date by which the corrections will be completed.
Please send your reply to the attention of Andrea H. Norwood, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issue in this letter, please contact Ms. Norwood at 407-475-4724.
Emma R. Singleton
Director, Florida District