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The basic theory behind Aguero's program is that ordinary eating, especially of meat products, leads to constipation and an accumulation of from 1/4 to 2 inches of hardened "mucus plaque" on the inner walls of the large intestine (colon). According to him, this accumulates heavy metals, interferes with nutrient absorption, causes people to gain weight, causes "toxins" to enter the body, and becomes an underlying cause of nearly every type of illness [3]. There is no scientific evidence to support these claims.

The booklet states that completing the Ultimate Cleanse six times in the first year will "return the colon to its original shape and remove the source of most sickness and disease—the hardened mucus plaque existing in it." However, the recommended program is considerably more elaborate than simply taking the products in the kit. It includes additional products; dietary modification (eating mostly fruits and vegetables); drinking distilled water; routine use of colonic irrigation; cooking with non-aluminum pots; and use of herbal and homeopathic products.

Aguero's claims are based on a theory of "autointoxication" that was medically accepted about 100 years ago but abandoned after scientific observations proved it wrong. In 1919 and 1922, it was clearly demonstrated that symptoms of headache, fatigue, and loss of appetite that accompanied fecal impaction were caused by mechanical distension of the colon rather than by production or absorption of toxins. Moreover, direct observation of the colon during surgical procedures or autopsies found no evidence that hardened feces accumulate on the intestinal walls [4].

Aguero's program is similar to one that was marketed for many years by Victor Earl Irons (1918-1998), one of the three "pioneers of nutrition" whom Aguero cites as inspirational to him. Irons claimed that virtually everyone has a "clogged colon," that deposits of fecal material cause "toxins and poisonous gases" to "seep into your blood and poison all your organs and tissues," and that "if every person in this country took 3 home colonics a week, 95% of the doctors would have to retire for lack of business. During the 1950s, his marketing activities got him into considerable legal trouble. In 1957, he received a one-year prison sentence for misbranding a vitamin mixture sold door to door. In 1959, shipments of eight products and accompanying literature shipped by V.E. Irons, Inc., were destroyed under a consent decree because the products were promoted with false or misleading claims. Other seized products were ordered destroyed in 1959 and 1960 [5].

Illegal Claims

In the infomercial, Aguero claims that users of his program will lose weight and achieve "a body immune to all sickness" by expelling plaque and parasites. He also claims that "thousands of people overcome just about every health problem feared today, including AIDS, all types of cancer, high blood pressure, diabetes, migraine headaches, PMS, fibroid tumors, and all types of bowel dysfunction." [6] These claims—and many others in the infomercial—are both preposterous and illegal.

The Federal Food, Drug and Cosmetic Act states that any product (other than a device) intended for the prevention or treatment of disease is a drug and that it is illegal to market new drugs that do not have FDA approval. I believe that the claims made for the 7-Day Miracle Cleanse violate this law and that the FDA can—and should—force Aguero's company to stop making them.

The FDA is apparently aware of the the 7-Day Miracle Cleanse's marketers. In September 2004, the FDA ordered the company to stop marketing its "Expanded Vision Colon Board," which it had advertised with claims of "detoxification, greater longevity, self healing, and improving health and the immune system." The warning letter stated that claims of this type made the enema system a Class III medical device that could not be legally marketed without FDA approval as safe and effective for its intended purpose [5].

The Federal Trade Commission enforces laws that require advertising to be truthful, nondeceptive, and backed by adequate evidence. I believe that the claims made for the 7-Day Miracle Cleanse violate this law and that the FTC can—and should—force the company to stop making them

For Additional Information

References

September 21, 2004WARNING LETTER

VIA FEDERAL EXPRESS

Mr. Anthony DeAguero
Vice President
7-Day Miracle Cleanse
31 Madrid
Tustin, California 92780

Dear Mr. DeAguero:

We are writing to you because a review of your web site, http://www.7dmc.com, revealed a serious regulatory problem involving the product known as the “Expanded Vision Colon Board,” which is marketed by your firm.

Under a United States law, the Federal Food, Drug, and Cosmetic Act (the Act), this product is considered to be a medical device because it is intended for use in the diagnosis or treatment of a medical condition or to affect the structure or function of the body. The law generally requires that manufacturers of medical devices obtain marketing clearance for their products from the Food and Drug Administration (FDA) before they may offer them for sale. This helps protect the public health by ensuring that newly introduced medical devices are safe and effective or substantially equivalent to other devices already legally marketed in this country.

According to your web site, the Colon Board is used for the purpose of home colon cleansing. From the design, the device appears to be an enema kit, a Class I device “intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon.” 21 CFR 876.5210. However, the intended uses of the device, as reflected in the claims on your web site, more closely resemble those for a colonic irrigation system intended for routine colon cleansing for general well being (21 CFR 876.5220(b)(2)), a Class III device for which premarket approval is required. Examples of the claims made on your web site for the Colon Board include detoxification, greater longevity, self healing, and improving health and the immune system.

Our records do not show that you obtained marketing clearance or approval before you began offering your product for sale. The kind of information you need to submit in order to obtain this clearance or approval is described on FDA’s device web site at www.fda.gov/cdrh/devadvice. FDA will evaluate this information and decide whether your product may be legally marketed.

Because you do not have marketing approval or clearance from the FDA, marketing your product is a violation of the law. In legal terms, the product is adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act. Your product is misbranded under the Act because you did not submit a section 510(k) premarket notification that shows your device is substantially equivalent to other devices that are legally marketed. Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may market your device, your product is also adulterated under the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective. For a product requiring premarket approval, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. 21 CFR 807.81(b).

Your Colon Board is also misbranded under section 502(o) of the Act, in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 and was not included in a list required by section 510(j).

You should know that these serious violation(s) of the law may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.

It is necessary to take action on this matter now. Please let this office know what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response to Mr. Paul Tilton, Chief, OB/Gyn, Gastroenterology and Urology Devices Branch (HFZ-332), Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Road, Rockville, Maryland 20850.

Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter does not necessarily address all of the obligations you have under the law.

Sincerely yours,

/s/

Larry D. Spears for
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health

For the lasted information on my dreams, please visit my Dream Forum here, or see below for the very latest posts.

Don't Buy the 7-Day Miracle Cleanse™

Stephen Barrett, M.D.

Illegal Claims

For Additional Information

References