Holographic Health, Inc.
FDA issued a warning letter to Holographic Health, Inc. (President Theodore Baroody) regarding 14 products — including Glyco-Well, Pan-Gest, Heart-Line, Passionate Pursuit, Better Mood, and others — sold on holographichealth.com. The agency determined these products were unapproved new drugs because website claims established intent to cure, mitigate, treat, or prevent diseases such as diabetes, arthritis, erectile dysfunction, depression, and hemorrhoids. The products were also found to be misbranded for lacking adequate directions for use, and Pink Lady was found to be improperly labeled as a dietary supplement despite being a topical product. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (23)
depression . . . Imbalances are . . . anxieties, phobias . . . manic-depression (bipolar) . . . One in a hundred people is diagnosed as suffering from schizophrenia. Better Mood is aimed at balancing the brain nutritionally and to stabilize it by a totally natural method.
Slippery elm bark [an ingredient listed in H.H.S. Formula] . . . contains a substance called mucilage . . . causing much relief from things like Gastroesophageal Reflux Disease (GERT) . . . Crohn's Disease, ulcerative colitis, diarrhea, diverticulitis and Irritable Bowel Syndrome [sic] (IBS).
[I]t is focused on increasing testosterone secretions from the glands related to this function. This . . . should assist in erectile dysfunction problems.
The 'price is right' for Male Prosexual. Cialis is selling for $41 dollars a pill at the drug store, and other natural enhancers are twice as much as we are charging!
GLYCO-WELL was formulated to regulate blood sugar issues
[T]he healing power of asparagus in heart arrhythmia conditions. . .
Use one drop in each eye one to three times a day depending upon your situation. It stings a little when you first put it in, but stops very soon. This is because you really need it. The more the sting, the more the need.
Dimethylaminoethanol (DMAE) [an ingredient listed in Better Mood] . . . It is excellent for depression, anxiety, and hyperactivity.
Anything that has to do with the pancreas, health will be addressed with Pan-Gest including blood sugar regulation.
The dangers of hypertension are 1) heart attack and 2) stroke with paralysis. Heart-Line is formulated to help your system prevent this kind of problem from occurring.
Gingko Biloba Leaf [an ingredient listed in Passionate Pursuit]: . . . may help support . . . impotence . . . In one study 78% of a group of men with impotence reported significant improvements without side effects.
Arthritis and all of its related "itis" conditions plague millions worldwide. With all the new information about the anti-arthritis drugs being dangerous, you may find Cherry Gold of great value . . . taking Cherry Gold if the joint pain is moderate to severe.
Mrs. M.C., nurse, had been diagnosed with a large breast tumor by her medical doctor. I gave her Aspara-Can capsules to help with her imbalanced heart beat [sic]. After two months, the heart normalized, and the breast tumor (which I do not treat) reduced by over 60%.!
As usual, we are making no claims that this product will work, but my clientele love it. It sure beats taking injections, if you can get them at all.
A Natural Eye Wash For All Complaints
It is also helpful for regulating the inflammatory response.
Otitis media is the number one problem for children today…Most ear infections are the result of fungus.
A SOOTHING OINTMENT FOR HEMORRHOID, BURN, AND INSECT BITE IMBALANCES
Very mild to very severe B12 deficiencies can cause different levels of problems. The list of imbalances that nutritional research has revealed related to B12 insufficiencies are startling. These are: . . . Depression . . . Shooting Pains . . . Menstrual Disturbances . . . Celiac Disease.
The 'price is right' for Passionate Pursuit. Cialis is selling for $16 dollars a pill at the drug store and [sic] other natural enhancers are three times as much as we are charging!
Regulates Blood Sugar
Tri-Force supports the endocrine system nutritionally. Researched and documented issues of the pituitary are: . . . excessive urination . . . chronic headaches . . .non-insulin responsive diabetic. . . sexual problems . . . mental illness . . .numbness and tingling sensations
Potency Wood Bark [an ingredient listed in Passionate Pursuit]: . . . helps with . . . impotence. It has been used successfully in studies to treat erectile dysfunction
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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