Inspections, Compliance, Enforcement, and Criminal Investigations
Cayenne Company, Onc. 21-Sep-06
Department of Health and Human Services
Public Health Service
Minneapolis District Office
September 21, 2006
RETURN RECEIPT REQUESTED
Refer to MIN-06-38
Jaime P. Humnick
Cayenne Company, Inc.
dba The Heart Foods Company
2235 E. 38th Street
Minneapolis, MN 55407-3083
Dear Mr . Humnick:
On June 15 and 19, 2006, an investigator with the Food and Drug Administration(FDA) conducted an inspection of your facility at 2235 E. 38th Street, Minneapolis, Minnesota. During the inspection the investigator collected product labels and other labeling, including promotional brochures, for your Heart Foods Company products C's The Day, Hawthorn Plus™, Health Food Caps™, Heart Food Caps, Keep It Up™, Nite Time Caps, Power Caps, Power Plus, Releve, Stress Food Caps™, and Thinking Caps™. We also reviewed labeling for some of these products on your website, www.heartfoods.com. Our review of your product labeling shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA's implementing regulations through links on FDA's Internet web site 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. The therapeutic claims on your product labeling establish that these products are intended to be used as drugs. The marketing of these products with these claims violates the Act.
Specific examples of claims in your product labeling that promote your products as drugs are as follows:
From your "Straight to the Heart" promotional brochure and order form:
Keep It Up:
"Saw palmetto [identified as an ingredient in your Keep It Up product] helps shrink enlarged prostate tissue. . . ."
"The herbs [in your Releve product] are anti-inflammatory and can be used daily for long term relief of pain and inflammation."
"[R]elieve pain and inflammation from joint stiffness ."
Nite Time Caps:
"Passion flower [identified as an ingredient in your Nite Time Caps product] has been used for centuries for anxiety and insomnia."
From your "Step Up to the Power promotional brochure:
"C's" The Day:
" "Use during the cold and flu season."
From your "Heart Foods Co . -Please Read This First!" promotional brochure:
(included with the purchase of your products labeled as containing the ingredient cayenne, including: C's The Day, Health Food Caps™, Heart Food Caps, Keep It Up™, Power Caps, Power Plus, Releve, Stress Food Caps™, and Thinking Caps™)
"Cayenne promotes circulation by decreasing blood levels of fibrin. Excess fibrin can promote excess clotting. Blood clots are associated with up to 90 percent of all heart attacks. Cayenne may also help the body excrete unwanted cholesterol and lower blood pressure."
"According to the late Dr. Robert C. Atkins, cayenne helped his patients with heart rhythm disturbances, angina, and hypertension: 'I've been giving cayenne, in combination with the herb hawthorn to people with clearly diagnosable heart problems. I have been very impressed with the results'. Dr Atkins had great clinical success reversing diabetes and heart disease!"
From your "The Fight for Heart Health Heats Up" promotional brochure:
[included with the purchase of your product Heart Food Caps, labeled as containing the ingredient cayenne]
"According to the medical literature, [cayenne]:
Cuts cholesterol. Cayenne causes the body to dramatically increase its excretion of cholesterol, Indian researchers have found.
Thins the blood . [Cayenne] . . .decreases blood levels of fibrin, which thickens the blood. Lowering fibrin in turn reduces the risk of blood clot formation, which could cause a stroke or heart attack.
Eases blood pressure. Lab experiments conducted on animals, reported in Nutrition Reports International, show that cayenne lowers hypertension a benefit that presumably applies to humans.
Researchers believe that much of the trick behind this bit of therapeutic magic is cayenne's ability to dilate blood vessels. Right off the bat, that helps to lower blood pressure."
"German studies have shown that the flavonoids in hawthorn dilate coronary blood vessels. That-lowers blood pressure."
From your website:
Hawthorn Plus and Heart Food Caps (labeled as containing the ingredient hawthorn):
"Why Hawthorn? . . .According to Dr. Atkins, hawthorn reduces high blood pressure in several ways. `Hawthorn dilates the larger blood vessels, inhibits angiotensin-converting enzyme (ACE), increases the heart's functional capacity, and mildly decreases fluid retention.'"
Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, they are also "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 an approved New Drug Application (NDA), 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.
Further, even if your Heart Food Company products C's the Day, Hawthorn Plus!™, Health Food Caps™, Heart Food Caps™, Keep it Up™, Power Caps, Power Plus, Releve, and Thinking Caps™ did not contain disease claims in their labeling that cause them to be drugs, they would still be misbranded as dietary supplements.
Specifically, these products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)], in that the label identifies the product as a dietary supplement on the information panel, but fails to bear nutrition labeling in "Supplement Facts" format as required under Title 21, Code of Federal Regulations (CFR), 101.36.
Further, your products C's The Day, Hawthorn Plus™, Health Food Caps™, Heart Food Caps, Keep It Up™, Power Caps, Power Plus, Releve, and Thinking Caps™ are misbranded within the meaning of section 403(i)(1) and 403(s) (2) (B) of the Act [21 U.S.C. § 343(s)(2)(B)]. Though each of these products is identified as a dietary supplement in the information panel on the product label, the labels fail to identify the products using the term "dietary supplement," or a similar term describing the type of supplement (e.g., "herbal supplement"), as part of the statement of identity on the principal display panel, as required under 21 CFR 101.3(d) and (g).
Your products C's The Day, Hawthorn Plus™, Health Food Caps™, Heart Food Caps, Keep It Up™, Power Caps, Power Plus, Releve, and Thinking Caps™ are misbranded within the meaning of 403(s)(2)(C) of the Act [21 U.S.C. § 343 (s)(2)(C)], in that the labels fail to identify the part of the plant (e .g., root, leaves) from which botanical dietary ingredients in the products are derived (see 21 CFR 101.4(h)). For example, your product Power Plus lists the ingredient Ginger, but does not identify the part of the plant used (e.g ., "Ginger root").
This letter is not intended to be an all-inclusive review of your product labels and promotional materials. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your product labels, web site, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct any violations, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products [21 U.S.C. §§ 332 and 334].
Please advise this office, in writing and within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur . Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your reply should be directed to Judy E. Heisick, Compliance Officer, at the address indicated on the letterhead. Ms. Heisick may be reached at (612) 758-7118.
W. Charles Becoat