FDA Sends Warning Letter to Aloe Vera Product Marketer

FDA Sends Warning Letter to Aloe Vera Product Marketer

September 28, 2010, The Food & Drug Administration sent a letter to Enriching Gifts for a myriad of violations after reviewing information available on the company's web sites in July 2010 (www.enrichinggifts.com, which also linked directly to www.enzymesfordigestion.com).

The FDA Warning Letter notes that the search went beyond the available web pages, going into information contained within PDF's regarding specific products. The Warning Letter further noted claims were supplemented by the use of metatags (key words) used to bring consumers to the www.enzymesfordigestion.com website through Internet searches. These metatags include terms such as "Pro-Biotics kill parasitic bacteria just like antibiotics", "ANTIBACTERIAL", and "Anti-viral".

The Warning Letter also states that the products referenced within are not generally recognized as safe and effective for the referenced uses and are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. A mention of the improper usage of testimonials is also made.

The Warning Letter specifically mentions the following concerns in regards to the product "Aloe Ace Max", including:

...are promoted for conditions that cause the 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 on these web sites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
From the PDF file accessed by clicking on "about aloe ace-max" on the web page entitled "enriching gifts international's core product is its exclusive plant enzyme formula":

"ALOE ACE-MAX™ ... · Reduces inflammation - involved in ulcerative colitis, arthritis, and gastric reflux. . .. · Helps with the reduction of blood sugar with both Type I and Type II diabetes. . .. · Important in preventing and treating arteriosclerosis, heart disease, and Parkinson's disease ... · Direct anti-bacterial and anti-viral effect. ..· Powerful healing effect on AIDS, cancer ... · Causes the body to produce a natural chemical (tumor necrosis factor) that functions to shut off the blood supply to tumors"
· "Cancer Research ... · All of the immune modulating effects from Aloe [ingredient in product] contribute greatly to the prevention and healing of malignant cells. (Ian Tizard, Ph.D. and Maurice Kemp, Ph.D., Texas A&M)"

· "Benefits Lung Cancer ... · Aloe [ingredient in product] was the only of the plant foods that was protective against cancer. "The results of plant epidemiology suggest that aloe prevents human pulmonary carciogenesis (lung cancer)", and aloe is "widely preventive or suppressive against various human cancers." (Japanese Journal of Cancer Research)"

· "AIDS Research ... · In many of the studies [of the ingredient aloe] there was an average of 70% improvement in symptoms and laboratory criteria within 3 to 4 months. (Terry Pulse, M.D., Reg McDaniel, MD., Terry Watson, D.O., Dr. Clumeck). .. · Many patients stated that opportunistic infections had stopped and they were able to return to normal activity.... · Lab studies showed that helper lymphocytes rose to three times the pre-treatment level. HIV-1 virus could no longer be cultures. P-24 antigen levels for the virus dropped or became negative.... · Researchers discovered that Aloe mucilaginous polysaccharides alter synthesis and thus the structure of the AIDS virus envelope necessary for infecting lymphocytes. (Vanderbilt Medical Center. Nashville, Tennessee)"

· "Eases Intestinal Problems ... · Aloe [ingredient in the product] can be effective for treating inflammatory bowel disease. (Journal of Alternative Medicine) ... · Other studies have shown that aloe helps ... relieve constipation and gastric ulcers." · "Reduces Blood Sugar in Diabetes ...· Aloe [ingredient in the product] reduced the blood sugar levels in diabetes. (Hormone Research) "

· "Aloe Vera[ingredient in the product] ... has been proven for thousands of years to be one [sic] the most effective healing agents available for wounds and also when ingested into the body for healing."

· "Aloe Vera [ingredient in product] Benefits: Anesthetic-Relieves itching, swelling and pain ... Anti-Allergenic ... Antibiotic Action ... Anti-Fungal Activity ... Anti-Inflammatory ... Arthritis-Helps reduce Arthritis symptoms by reducing inflammation in joints already afflicted by arthritis Bowel - Detoxifies bowel - Effective for treating inflammatory bowel disease Diabetes-Reduces Blood Sugar level in Diabetics ... Digestive Stimulant-Neutralizes stomach acidity, Relieves constipation and gastric ulcers ... Healing Action-Heals burns, Decreases surgical recovery time, Speeds wound healing ... "

"This is a clear sign that the FDA is continuing to actively review and look for products that are not in compliance with applicable regulations. The 'low hanging fruit' that is companies marketing their products actively via the web or corporate controlled websites is an invitation for FDA action", said Devon Powell, Executive Director of the IASC. "I would encourage anyone in the industry to purchase and review the IASC/AHPA seminar 'Allowable Claims and Claims Substantiation: How to Comply with the Law & Maximize your Marketing', which featured representatives from FDA, FTC and legal counsel, in order to better understand the regulations and what can lawfully be said in regards to the marketing of aloe vera products."

The full warning letter can be found by clicking THIS LINK.

For more information contact:

Devon Powell
Executive Director, IASC
dpowell@iasc.org
Phone: 301.588.2420 x102
Cell: 240.398.8018
8630 Fenton St., Ste. 918 | Silver Spring, MD | 20910