Inspections, Compliance, Enforcement, and Criminal Investigations
Health MarketPlace.com 16-Oct-07
Department of Health and Human Services
Public Health Service
October 16, 2007
RETURN RECEIPT REQUESTED
Michael Kellett, Owner
6355 Tamar Drive
Columbia, Maryland 21045
Dear Mr. Kellett:
The Food and Drug Administration (FDA) acquired bottles of your Boswella Cream™ (Net Wt. 4 oz), Choless Control (120 Capsules), and Aller-DMG™ (60 Tablets). Our review of these labels as well as information found on your firm's website (www.healthmarketplace.com) found that these products are in serious violation of the Federal-Food, Drug, and Cosmetic Act (the Act). You can find the Act and regulations on FDA's website at http://www.fda.gov.
Under section 201(g)(1)(B) of the Act [21 U.S.C § 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs. Based on claims that appear on the labeling of your Boswella Cream™, Choless Control, and Aller-DMG™'" products, FDA has determined that these products are promoted for conditions that cause them to be drugs, and the marketing of these products with these claims violates the Act .
Examples of some of the claims observed on your web site include:
1. Boswella™ Cream, Net Wt. 4 oz
•"Boswellic acids have anti-inflammatory and anti-arthritic action in acute and chronic models of inflammation. They. . .appear to suppress the inflammation . . . ."
•"For many people, Boswella reduces swelling in the joints and morning stiffness, increases mobility, and reduces arthritic pain."
•"Leukotrienes cause inflammation by promoting free radical damage, calcium dislocation, autoimmune responses, cell adhesion and the migration of inflammation-producing cells to the inflamed-body area . Boswella inhibits inflammation by blocking the synthesis of leukotrienes."
•"[A] number of doctors have provided anecdotal reports of relief of arthritis symptoms in patients using a topical cream containing boswella."
2. Choless Control, 120 Capsules
• "Helps lower cholesterol naturally"
3. Aller-DMG™, 60 Enteric Coated Tablets
•"Quercetin reduces the intensity of allergic reactions by supporting histamine within normal ranges ."
•"[R]educe discomfort associated with the aspects of histamine release including skin irritation, redness, sneezing, stuffy nose, overproduction of phlegm, skin and eye irritation, and runny nose."
•"[E]liminate discomfort associated with allergic responses."
•"[A]lleviate the discomfort associated with respiratory dysfunction by reducing histamine release and relieving swelling."
Because these products are not generally recognized as safe and effective when used as labeled, they 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 United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)].
Drug products intended for some of the indications such as those promoted for Boswella Cream are being evaluated under the Tentative Final Monograph (TFM) for OTC External Analgesics in the Over- the-Counter (OTC) Drug Review . However, based on the combination of active ingredients in the Boswella Cream, it would not be considered under the TFM. In addition to the active ingredients specifically declared on the product label (methyl salicylate 10% and capsaicin 0.25%), the Boswellia Serrata would also be considered an active ingredient since it is clearly promoted on your web site, as having a therapeutic effect and is represented as the most important ingredient in the product, even giving rise to the product's name. The TFM, published in the Federal Register on February 8, 1983 (48 Fed. Reg. 5852), did not include this particular combination of ingredients, methyl salicylate, capsaicin, and boswellia serrata: Furthermore; the indications for the Boswella Cream, such as suppressing inflammation, are not included in the TFM for OTC external analgesics and we are unaware of any evidence that such a product formulated and labeled as Boswella Cream was available in the U.S. market at the inception of the OTC Drug Review.
The Boswella Cream is also a new drug based on the transdermal delivery system. The principal display panel of Boswella Cream states, "Patented Delivery System Liposomes" and, under the heading "Other Ingredients," the label states, "[i]n an exclusive patented liposome (US Patent 269,979) delivery system to enhance penetration . . . ." and "stinging or tingling sensation . . . related to the mechanism of action of this product . . . ." These statements suggest that the ingredients penetrate the skin beyond its outer layer. This type of delivery is known as "transdermal. "
FDA's regulations state that a drug may be considered a new drug because of the newness of its dosage form or the method or duration of administration or application suggested in its labeling [21 CFR § 310.3(h)(5)]. A transdermal delivery system for a drug is not generally recognized by experts to be safe and effective for any intended uses. Accordingly, FDA considers all transdermal drug delivery products to be new drugs under § 201(p) of the act and under 21 C.F.R. § 310.3. Your product is labeled as having a transdermal delivery system; accordingly, it is also a new drug for that reason under the Act and its implementing regulations. Furthermore, even if your Choless Control product was not a drug, it would still be misbranded as a dietary supplement within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] for failing to bear nutrition labeling as required by 21 CFR 101.36(a).
This letter is not intended to be an all inclusive review of your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations . You should take prompt action to correct these deviations. Failure to immediately cease distribution of violative products may result in regulatory action by FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
Finally, we note that, according to your web site, your Choless Control product contains the allergen "soy," but you have not declared that ingredient on your product label. For your information, the,Food Allergen Labeling and Consumer Protection Act (FALCPA) became law in 2004. FALCPA amended the Food, Drug, and Cosmetic Act to require food labels to clearly disclose ingredients that are or contain a protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. The labeling requirements of FALCPA went into effect on January 1, 2006. Any food product labeled on or after this date must be in compliance with FALCPA . Failure to comply with FALCPA causes a food to be misbranded under section 403(w) of the Act. A copy of FALCPA, including its specific labeling requirements, can be accessed on our website at http://www.cfsan.fda.gov/~dms/alrgact.html and additional guidance for industry can be accessed at http://www.cfsan.fda.gov/~dms/alrguid2.html
We request that you notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations . Your response should address the comments listed above and include examples of documentation showing that corrections have been achieved. If corrective action can not be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your reply should be directed to Randy F. Pack, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, please do not hesitate to contact Mr. Randy F. Pack at (410) 779-5454, extension 417.