WARNING LETTER
Holographic Health, Inc.
MARCS-CMS 613874 —
September 10, 2021
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Theodore Baroody
Recipient Title
President
Holographic Health, Inc.
516 E. Market Street
Kingsport
,
TN
37660
United States
Issuing Office:
Division of Human and Animal Food Operations East V
United States
WARNING LETTER
September 10, 2021
Dear Mr. Baroody:
This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the following Internet address: www.holographichealth.com. It was determined that you take orders for your products “Glyco-Well,” “Pan-Gest,” “Heart-Line,” “Aspara-Can,” “Cherry Gold,” “H.H.S. Formula,” “Brain Balance,” “Passionate Pursuit,” “Better Mood,” “Male Prosexual,” “Ear Well,” “Pink Lady,” “Eye-C,” and Hemorr-Norm.” The claims on your website establish that these products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)(1)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
GLYCO-WELL
• “GLYCO-WELL was formulated to regulate blood sugar issues”
• “Regulates Blood Sugar”
• “Gymnema Sylestre Extract [an ingredient listed in Glyco-Well] . . . Powerful herbal agent for effective blood sugar regulation”
• “Jambolan [an ingredient listed in Glyco-Well] . . . An Ayurvedic botanical traditionally used to balance blood sugar levels”
PAN-GEST
• “Anything that has to do with the pancreas, health will be addressed with Pan-Gest including blood sugar regulation.”
• “It is also helpful for regulating the inflammatory response.”
• “Bromelain [an ingredient listed in Pan-Gest] . . . Very helpful for inflammation in the body around joints.”
• “Celiac disease is a digestive disease that damages the small intestine and interferes with absorption of nutrients in food . . .”
HEART-LINE
• “Potassium Orotate [an ingredient listed in Heart-Line]. . . Used in heart rhythm 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.”
ASPARA-CAN
• “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%.!”
• “[T]he healing power of asparagus in heart arrhythmia conditions. . .”
CHERRY GOLD
• “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.”
• “Black Cherry Powder [an ingredient listed in Cherry Gold]. . . maintaining healthy uric acid levels. When uric acid levels are not kept in the normal range, the body is more prone to gout and joint inflammation. Cherries have a long history of supporting optimal inflammatory response.”
• “Bromelain [an ingredient listed in Cherry Gold] . . . Helpful for pain . . .”
• “Goat’s Rue [an ingredient listed in Cherry Gold] . . . recommended . . . for pain relief”
• “Nutmeg [an ingredient listed in Cherry Gold] . . . for pain relief”
H.H.S FORMULA
• “Marshmallow root [an ingredient listed in H.H.S. Formula] . . . Marshmallow is most commonly used to treat sore throats and dry coughs. The Marshmallow plant, especially the leaves and roots, contains polysaccharides that have antitussive … and antibacterial properties.”
• “Ginger root [an ingredient listed in H.H.S. Formula] . . . Enough scientific research exists to support ginger’s ability to help reduce nausea from chemotherapy treatments . . . It seems particularly good for hiatal hernia sufferers.”
• “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).”
• “Fennel [an ingredient listed in H.H.S. Formula] . . . It is a tested remedy for . . . acid stomach, gout, cramps, colic and spasms . . . Excellent for obesity.”
BRAIN BALANCE (Formerly TRI-FORCE)
• "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”
PASSIONATE PURSUIT
• “[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 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!”
• “Tribulus Terrestris Fruit [an ingredient listed in Passionate Pursuit]: This ingredient helps with . . . impotence, inability to maintain an erection . . .”
• “Korean Ginseng Root [an ingredient listed in Passionate Pursuit] . . . Modern therapeutic uses refers to . . . cardiovascular diseases . . .”
• “Potency Wood Bark [an ingredient listed in Passionate Pursuit]: . . . helps with . . . impotence. It has been used successfully in studies to treat erectile dysfunction”
• “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.”
• “Cnidium Monnieri Seed Extract [an ingredient listed in Passionate Pursuit] . . . it has been used to treat male sexual dysfunction.”
• “The Velvet Bean[an ingredient listed in Passionate Pursuit] has many traditional and medicinal usages including treating pain, cholera, diabetes, infertility, scorpion bites, snakebites, toothaches . . . reduces inflammation . . . kills some parasites . . . reduces spasms…lowers blood sugars, reduces fever, lowers cholesterol. . .”
• “Damiana Leaf [an ingredient listed in Passionate Pursuit]: . . . known for its help with impotence . . .”
BETTER MOOD
• “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.”
• “Lithium Orotate [an ingredient listed in Better Mood] . . . balance a depressive state.”
• “Dimethylaminoethanol (DMAE) [an ingredient listed in Better Mood] . . . It is excellent for depression, anxiety, and hyperactivity.”
MALE PROSEXUAL
• “It 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!”
EAR WELL
• “All Natural Oil Formulation For Ear Imbalances”
• “Otitis media is the number one problem for children today…Most ear infections are the result of fungus.”
PINK LADY
• “A Transdermal Vitamin B12 Cream”
• “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.”
• “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.”
• “There is some research that B12 is linked to autoimmune imbalances. This is where the immune system goes haywire and produces antibodies that fight against the body’s own tissues. In conclusion, we all need B12. Practically everyone will benefit by getting more that they are presently absorbing in their systems.”
EYE-C
• An image of the product with the container label bearing the text “A NATURAL EYE SUPPORT” on the label
• “A Natural Eye Wash For All Complaints”
• “‘The Windows of the Soul’ need [to be] . . . nourished and protected. When I formulated EYE-C, all these considerations were made. Particularly, I was attempting to ‘feed the eye.’”
• “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. Sometimes one eye will sting more than the other which means that particular eye is stressed more than the other.”
HEMORR-NORM
• An image of the product with the container label bearing the text “A SOOTHING OINTMENT FOR HEMORRHOID, BURN, AND INSECT BITE IMBALANCES” on the label
• “There are different types of hemorrhoids. Some bleed, some protrude, some hurt, and some don’t. But all are problematical [sic]. It appears that what causes their presence is a rather complicated mater. It is not just excessive lifting or constipation. It is involved with many interrelated body systems. Among these are coccyx problems and bowel imbalances. I have also recommended this ointment for excessively rough cracking skin on the feet and hands with excellent results. It can also be used on eternal sores.
Unapproved New Drugs
Information on your website at www.holographichealth.com indicates that you intend to market your “Pink Lady” product as a dietary supplement. For example, “Pink Lady” is labeled with a Supplement Facts panel; however, it is marketed for topical use. “Pink Lady” does not meet the definition of a dietary supplement under section 201(ff)(2)(A)(i) of the FD&C Act, [21 U.S.C. 321(ff)(2)(A)(i)]. Only products that are intended solely for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body through the skin or mucosal tissues are not intended for ingestion. Therefore, your “Pink Lady” is not a dietary supplement under section 201(ff) of the FD&C Act, [21 U.S.C. § 321(ff)].
Your “Glyco-Well,” “Pan-Gest,” “Heart-Line,” “Aspara-Can,” “Cherry Gold,” “H.H.S. Formula,” “Brain Balance,” “Passionate Pursuit,” “Better Mood,” “Male Prosexual,” “Ear Well,” “Pink Lady,” “Eye-C,” and “Hemorr-Norm” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. No approved applications are in effect for your products.
Misbranded Drugs
Your “Glyco-Well,” “Pan-Gest,” “Heart-Line,” “Aspara-Can,” “Cherry Gold,” “H.H.S. Formula,” “Brain Balance,” “Passionate Pursuit,” “Better Mood,” “Male Prosexual,” “Ear Well,” and “Pink Lady,” products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) The aforementioned 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. FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
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. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to U.S. Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions with regard to this letter, please contact Allison C. Hunter, at (513) 679-2700 Ext. 2134 or via email at ORAHAFEAST5FirmResponses@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
09/28/2021
Regulated Product(s)
Drugs
Food & Beverages