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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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For Earth, Inc. 8/19/11

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770


 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
FLA-11-39


August 19, 2011

For Earth, Inc.
Attn: Mr. Miguel Gallimore
14221 SW 120th Street
Suite 215
Miami, FL 33186

Dear Mr. Gallimore:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.migenetics.com in August 2011 and has determined that your MiGenetics products, African Origin, Asian Origin, Hispanic Origin, and European Origin, 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)].  The claims 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 access the Act and its implementing website from links on FDA’s homepage www.fda.gov.

Examples of some of the claims observed on your website include:

On a webpage, accessed for a product labeled “African Origin” found on your “Products” webpage:

■ “ Amaranth Sprout (Zinc): … [Z]inc [an ingredient in your product] has been claimed to possess antiviral activity.”
■ “There is strong scientific evidence to suggest that zinc may help manage or reduce symptoms of sickle cell anemia. [S]tudies reported … decreased numbers of crises and sickled cells following zinc treatment.”
■ “Amaranth Sprout (Vitamin D): … Recently, research also suggests vitamin D [an ingredient in your product] may provide protection from osteoporosis, hypertension (high blood pressure), cancer, and several autoimmune diseases.
■ “Amaranth Sprout (Pantothenic Acid, Vitamin B5): Vitamin B5 [an ingredient in your product] has been used to treat the following conditions … alcoholism … alopecia, Alzheimer's disease, … asthma.”
■ “Amaranth Sprouts:  Amaranth [an ingredient in your product] is one of the grains highest in fiber content … This makes Amaranth an effective natural agent against cancer and heart disease.”
■ “Amaranth Sprout (Vitamin D): … [S]upplemental vitamin D may prevent the development of colorectal cancer … There is preliminary evidence based on laboratory and human studies that high-dose vitamin D may be beneficial in the treatment of prostate cancer.”
■ “Amaranth Sprout (Niacin (vitamin B3, nicotinic acid), Niacinamide): Niacinamide may prevent diabetes”
■ “Amaranth Sprout (Niacin (vitamin B3, nicotinic acid), Niacinamide): Niacin decreases levels of cholesterol, lipoprotein (a), and fibrinogen, which can reduce the risk of hart disease. Used to treat coronary heart disease (CHD)”
■ “Amaranth Sprout (Niacin (vitamin B3, nicotinic acid), Niacinamide): Used in the prevention of high blood pressure.”
■ “Amaranth Sprout: … can help one avoid urinary tract infections, kidney stones.”

On a webpage, accessed for a product labeled, “Asian Origin,”:

■ “Brown Sea Weed [an ingredient in your product] is used in treatments for … obesity, high cholesterol, arteriosclerosis … asthma, … thyroid disorders … and urinary diseases, for reducing the incidence of tumors, ulcers ....”
■ “Brown Sea Weed … Contains Soluble Polysaccharides: Which are antibiotic and antiviral ….”

On a webpage, accessed for a product labeled, “Hispanic Origin,”:

■ “Graviola [an ingredient in your product] provides tremendous Cancer Fighting Abilities.”
■ “Graviola [an ingredient in your product] … Properties/Actions: 

1. Antibacterial
2. Anticancerous
3. Antiparasitic
4. Antitumorous …”

■ “Graviola has been praised for its abilities to fight cancer … kill viruses and parasites, as well as to lower blood pressure … and prevent depression.”

On a webpage, accessed for a product found on your “Products” webpage labeled, “European Descent”:
 
■ “1. Chromium [an ingredient in your product]… helps deter diabetes …. [I]t can help to prevent hypertension or high blood pressure.”
■ “2. Cobalt [an ingredient in your product] … Act[s] as an anti-oxidant, helping to protect our cells against cancer and other disease.”
■ “3. Selenium [an ingredient in your product]: …In recent years, laboratory experiments, clinical trials and epidemiological data have established the role of selenium in the prevention of a number of degenerative conditions including cancer, inflammatory diseases, cardiovascular disease, neurological diseases … and infections. …”
■ “4. Magnesium [an ingredient in your product]: … is used by doctors to treat irregularity heart rhythm [sic]. Other health benefits of magnesium are osteoporosis, eclamptic seizures…asthma, diabetes … back pain and psychiatric disorders.”

o  “Prevention of eclamptic seizures: Magnesium sulfate is best treatment for preventing eclamptic seizures in expectant mothers who have hypertension.”

■ “5. Copper [an ingredient in your product] … Benefits: …

■ Arthritis: … it’s anti-inflammatory actions to assist in reducing the symptoms of arthritis …. Copper also works as a home remedy for arthritis ….”
■ “Bactericidal properties: Studies have shown that copper can destroy or inhibit the growth of bacterial strains such as E Coli.”
■ “Immunity: Copper … ensures better wound healing. … It also works as a cure to anemic problems.”  “Reduces cholesterol: … copper can reduce bad cholesterol level and helps in increasing beneficial cholesterol.”

■ “Preventing development of osteoporosis: Magnesium along with calcium and Vitamin D … eliminates the chances of developing osteoporosis ...”
■ “1. Vitamin A [an ingredient in your product] … Vitamin A guards us against bacterial, viral, parasitic infections, guards us against heart disease, stroke and lowers blood cholesterol level. … The supplement … also … help[s] people suffering from glaucoma and measles.”
■ “2. Vitamin B1 [an ingredient in your product] … Vitamin B1 deficiency can thus result in irregular cardiac functions. People suffering from congestive heart failure, when administered vitamin B1 intravenously for seven days, showed considerable improvements in their echocardiograms, which proves that vitamin B1, can prevent heart disease.”
■ “Prevents Alzheimer’s disease: Vitamin B1 is thought to slow down the progression of Alzheimer’s disease.” 
■ “[V]itamin C… thus equip[s] the immune system … to fight against … cancer causing compounds.”

■ “6. Vitamin E [an ingredient in your product]: The health benefits of Vitamin E or Tocopherol include Cancer and Cardiovascular diseases, improving … heart diseases, cataract ….”
■ “What health disorders has The White Bean been used as a Treatment Method: …

■ “Diabetes…
 Cancer of the blood…
■ Rheumatism and arthritis…
■ Urinary tract disorders…”

■ “White beans contain trace amounts of phaseolamin … a possible treatment for obesity and diabetes.”
■ “This vegetable [white beans] plays an important part in preventing the development of diabetes.”

In addition, your website includes claims in the form of testimonials that establish the intended use of your product as a drug. Examples of these testimonials include the following:

■ “David is doing great. Three weeks after his quad-bypass and arotic [sic] valve replacement … His Cardiologist said that the Migenetics was a good product and David can continue to take it. Migenetics may have kept him from having a heart attack.”
 
■ “I have been taking MiGenetics for almost two months. In September my cholesterol level was 285, triglycerides were 155 and cholesterol ratio was 4. Had my labs again in December and was very suprised [sic] to find my cholesterol had dropped to 188, triglycegrides [sic] were down to 85 and ratio now at 2.9. My thyroid levels have increased thus decreasing the doseage [sic] of synthroid (thyroid replacement medication). I am pleased with these results and will continue to take the MiGenetics product.”

■ “I have been diagnosed with Asthma as a child ... I am now a 51-year-old man, and over the years my Asthma developed into COPD. I have been taking Migenetics for only 2 weeks … I had an appointment with my lung doctor. … I had to go in 30 minutes early to take a series of breathing tests … to find out if there was changes from my last visit 2 and half months earlier. When he (my Doctor) came in with the results, he was beyond himself … asking me, what have you been doing? … I actually found out that my breathing and lungs had improved. No more wheezing, rumbling, just a clear flow of air … Since I have been taking the Migenetics I have had a tremendous change in how my body feels.”

■ “I started taking Migenetics…and have been taking at least 2 per day for 30 days. Prior to my taking this product I was testing my Glucose daily and was averaging in the 130’s and my Hemoglobin A1C tested at 7.5. Since I started taking Migenetics my average readings for my Glucose have tested 7 day average 123, 14 day average 122, and my 30 day average 126 and my Hemoglobin A1C tested at 6.5 (normal range is < 6.5). Of course this was more than impressive for me, but I have had very good results with my blood pressure as well. Prior to taking this product my average blood pressure readings were, on average, between 135- 129/85-88 and since taking this product my average reading as of this writing of is 128-119/83-72….”

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, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.  Thus, your product is 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 introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

Unauthorized Health Claims

Even if your Migenetics products were not unapproved new drugs, your African and European Origin products would be misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)] because their labeling includes unauthorized health claims. As defined in 21 CFR 101.14(a)(1),  health claims are claims made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements, symbols or vignettes, characterize the relationship of any substance to a disease or health-related condition. The use of the following health claims misbrand your products because they have not been authorized either by regulation (see section 403(r)(3)(A)-(B) of the Act [21 U.S.C. 343(r)(3)(A)-(B)]) or under authority of the health claim notification provision of the Act (see section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]).

■ “Amaranth Sprout (Vitamin D): …  High-dose vitamin D supplementation may be associated with a slightly reduced risk of developing breast cancer ….” 

■ “Vitamin C [an ingredient in your product] … can help to reduce the probability of the occurrence some types of cancer ....”

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling.  It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA.  You should take prompt action to correct these violations.  Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. 

In addition, we note the following therapeutic claim on your Facebook account, “MiGenetics” accessed at http://www.facebook.com/update_security_info.php?wizard=1#!/migenetics, as well as your Twitter account, accessed at http://twitter.com/migenetics:

■ November 29, 2010:  “Is Graviola the answer to fighting cancer? It could be a big part of it. “

In addition, the Facebook webpage has the following therapeutic claim:

■ November 9, 2010:  “Brown Seaweed has a reputation in assisting with the defeat of cancer!”

The Facebook webpage includes testimonials, as well as a link to your website where your products are sold. The testimonials include the following:

In a post dated November 29, 2010:

■ “Everything I have used to prevent my cancer from coming back and every supplement I use to heal my body from chemo is in MiGenetics…”

In a post dated December 2, 2010 from the same person:

■ “The right ingredients (supplements) have kept me from death due to cancer. Migenetics has helped repair the damage from chemo and made my body come back to healthy. Blood sugar elevated grossly from chemo is now below 110 thanks to MiGenetics. Get healthy and live longer. Get Migenetics.”

Finally, we also note that several of the above mentioned claims are included in a press release dated January 21, 2011 issued by PR Web and accessed at http://www.prweb.com/releases/2011/01/prweb4989434.htm. In this press release, your products, website, and contact information are prominently featured.

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 before you respond, 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  32779.  If you have any questions regarding any issue in this letter, please contact Ms. Norwood at 407-475-4724.

Sincerely,

/s/

Elizabeth W. Ormond
Acting Director, Florida District