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U.S. Department of Health and Human Services

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Enforcement Actions

Alternative Health Supplements 5/2/13

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

WARNING LETTER              

2013-DET-13
 
May 2, 2013
 
VIA UPS
 
Mr. Steve Johnson
Alternative Health Supplements
46658 Lakepointe Court
Shelby Township, MI 48315
 
Dear Mr. Johnson:
 
This letter concerns your firm’s marketing and sale of the following products on your website, www.alternative-health-supplements.com: “Regenerect,” “Alligin,” “Astaxanthin,” “HDL Cholesterol Management,” “Coral Calcium Supreme,” “Resveratrol,” “Shark Liver Oil,” “Blood Sugar Imbalance,” and “Supreme Immune Booster.” These products are marketed and sold in violation of the Federal Food, Drug, and Cosmetic Act (the Act) as described below. 
 
Regenerect
 
Your firm’s product “Regenerect” is an unapproved and misbranded new drug under the Act.
 
The product label for “Regenerect” includes claims such as the following: “Natural Male Enhancement,” “Drug-free blend of natural, herbal ingredients that enhance and support sexual experience,” and “Take 1 capsule . . . one hour before sexual activity.”  Additionally, your firm’s website included claims for “Regenerect” such as the following:
 
  • “Regenerect™ is an erectile stimulant that increases the size and duration of erections.”
 
  • “Regenerect™ helps to increase blood flow to the chambers, creating growth in the length and girth of the penis.”
 
  • “Natural, drug-free Regenerect™ is an alternative solution to prescription products like Viagra.”
 
The claims listed above make clear that “Regenerect” is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the body. These claims cause your product to be a drug, as defined in section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. 
 
You firm appears to market “Regenerect” as a dietary supplement because the product label includes the term “Supplement.” However, laboratory analysis conducted by the U.S. Food and Drug Administration (FDA) concluded that the “Regenerect” sold on your website contains tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor and is the active pharmaceutical ingredient in Cialis, an FDA-approved drug for the treatment of erectile dysfunction (ED). Under section 201(ff)(3)(B) [21 U.S.C. § 321(ff)(3)(B)], dietary supplements may not include an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved Cialis as a new drug on November 21, 2003. FDA is not aware of any tadalafil-containing products that were marketed as dietary supplements or foods before this date. As such, “Regenerect” is excluded from the definition of a dietary supplement. 
 
Moreover, “Regenerect” is a new drug, as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of “Regenerect” without such an approved application violates these provisions of the Act.
 
Furthermore, “Regenerect” is a “prescription drug” as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], because, in light of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary for its use, “Regenerect” is not safe for use except under the supervision of a practitioner licensed by law to administer it. As explained above, “Regenerect” contains tadalafil, a PDE-5 inhibitor. All PDE-5 inhibitors which have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a practitioner licensed by law to administer such drugs. 
 
According to section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], a drug is misbranded if, among other things, it fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (21 CFR § 201.5).  Prescription drugs can only be used safely at the direction and under the supervision of a licensed practitioner. Therefore, it is impossible to write “adequate directions for use” for prescription drugs. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson [21 CFR §§ 201.100(c)(2) and 201.115]. Because there is no FDA-approved application for your firm’s “Regenerect,” its labeling fails to bear adequate directions for its intended use, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. 
 
Additionally, under section 502(a) of the Act [21 U.S.C. § 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the Act [21 U.S.C. § 321(n)], provides that, in determining whether an article’s labeling or advertising “is misleading, there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising . . . fails to reveal facts material in light of such representations . . .” The labeling of “Regenerect” does not declare that it contains the PDE-5 inhibitor, tadalafil. The use of PDE-5 inhibitors, like tadalafil, can be associated with significant safety issues and the risk of serious adverse events. The undeclared tadalafil in “Regenerect” may pose serious health risks because consumers with underlying medical issues may take the product without knowing that it can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.  The failure to disclose the presence of tadalafil renders your product’s labeling false and misleading. “Regenerect” is, therefore, misbranded under section 502(a) of the Act [21 U.S.C. § 352(a)].
 
Your product “Regenerect” is also misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)] because the product’s labeling lacks adequate warnings for the protection of users. As previously noted, there is potential for adverse events associated with the use of “Regenerect,” particularly since someone who takes it would be unaware of the presence of the PDE-5 inhibitor, tadalafil. For example, patients who take nitrates and consume “Regenerect” may be at risk of life-threatening hypotension. Consequently, your product, “Regenerect,” is misbranded under section 502(f)(2) of the Act [21 U.S.C. § 352(f)(2)]. 
 
The introduction or delivery for introduction into interstate commerce of this misbranded product violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
“Alligin,” “Astaxanthin Advantage,” “HDL Cholesterol Management,” “Coral Calcium Supreme,” “Resveratrol,” “Shark Liver Oil,” “Blood Sugar Imbalance,” and “Supreme Immune Booster”
 
Your firm’s products, “Alligin,” “Astaxanthin Advantage,” “HDL Cholesterol Management,” “Coral Calcium Supreme,” “Resveratrol,” “Shark Liver Oil,” “Blood Sugar Imbalance,” and “Supreme Immune Booster,”  are unapproved and misbranded new drugs under the Act. 
 
Your firm’s website includes claims for these products such as the following:
 
“Alligin”: On the webpage titled, “Alligin (30 ct),” which states that Alligin contains Allicin:
 
  • “Perhaps Allicin's most important power in our modern age of antibiotic-resistant germs and ever-new microbial diseases (SARS, flesh-eating Strepto-coccus, West Nile encephalitis virus, AIDS ... ) is its amazing broad-spectrum antimicrobial activity.”
  • “…Ankri and Mirelman report on the antibacterial, antifungal, antiparasite, antiviral activity of Allicin. They note that a broad range of bacteria, including E. coli, Staphylococcus Aureus, Streptococcus pyogenes, Proteus mirabilis, Pseudomonas aeruginosa, Acetobacter baumanii, Klebsiella pneumoniae, Enterococcus faecium, Myco-bacterium tuberculosis, H. pylori, Salmonella, Clostridium and Shigella are ALL Allicin-sensitive.” (emphasis in original)
 
“Astaxanthin Advantage”: On the webpage titled, “Astaxanthin Advantage (60 ct)” under the heading, “The anti-aging benefits don’t stop there!”:
 
  • “…[S]tudies show that Astaxanthin may help the body avoid the onset of cancerous cells, assist with neurodegenerative diseases…”
  • “Astaxanthin…may assist in neurodegenerative conditions such as AMD, Parkinson’s, and ALS.”
  • “Astaxanthin may support the prevention of the initiation of cancer cells in the tongue, oral cavity, large bowel, bladder, uterus, and breast.”
  • “Studies show that Astaxanthin may inhibit…plaque formation, thus reducing risk of cardiovascular disease.”
 
“HDL Cholesterol Management”: On the webpage titled, “HDL Cholesterol Management (30 ct),” which states that the ingredients of HDL Cholesterol Management include “SitrinolTM”:
 
  • “In response to a growing demand for safe alternatives to prescription drugs Sytrinol was developed over a period of 12 years of painstaking research. Supported by 3 human clinical studies as well as animal studies showing a reduction of 22% in LDL….”
 
This webpage also features claims in the form of testimonials for this product. Examples of these testimonials include the following:
 
  • Under the heading, “Cholesterol is back to normal!”: “I had high cholesterol for over 4 years. The doctors gave me 2 different medicines, but I had to stop taking them…I’ve been taking Bell Cholesterol Control for 2 years and my Cholesterol is back to normal.”
  • Under the heading, “Family doctor wanted to put me on statin drugs!”: “…I tried instead Bell HDL Cholesterol Control. … My LDL cholesterol went down 37%. This put my HDL/LDL into the black from 4-5 to 1.8 and I had no side effects.”
  • Under the heading, “Better than my doctor's pills!”: “I was for 15 years on prescription cholesterol pills, which gave me muscle pain and cramps. I've now used your Bell Cholesterol Control now for 3 month and I'm so much better.”
 
“Resveratrol”: On the webpage, “Resveratrol (60 ct)”:
  • “Resveratrol is also gaining growing recognition for its promise in fighting age-related diseases ranging from dementia to diabetes.”
  • “Lower blood sugar”
  • “Resveratrol may inhibit platelets from clumping together, thus reducing the risk of deadly blood clots that can lead to heart attack and stroke.”
 
“Coral Calcium Supreme”: On the webpage titled, “Coral Calcium Supreme (90 ct)”:
  • “Robert Barefoot's Coral Calcium Supreme helps your body fight disease - NATURALLY!”
  • “Robert Barefoot's Coral Calcium raises you [sic] body's pH level, which … fights off diseases.”
  • “Coral Calcium Supreme restores your alkalinity . . . Most degenerative diseases attributed to aging such as cancer, osteoporosis, heart disease, and other diseases, such as allergy, kidney stones and gallstones, have all been scientifically linked to mineral deficiencies. Individuals with these deficiencies will have more acidic body fluids. Individuals who are healthy will have relatively alkaline body fluids.”
 
“Blood Sugar Imbalance”: On the webpage titled, “Blood Sugar Imbalance/Metabolism (60ct),” claims in the form of testimonials are featured for this product. Examples of these testimonials include the following:
 
  • “Bell Blood Sugar Imbalance Helped with my hypoglycemia! I’ve had problems with hypoglycemia for 23 years. Diet changes helped as well as some supplements. Your Bell Blood Sugar Metabolism #40 brought the biggest change.”
  • “For 1-1/2 years I had blood sugar problems. After using Bell Blood Sugar Metabolism for 30 days my blood sugar level became on average 5-6 daily and I no longer use Mettforin [sic] for my migraines that gave me side effects I didn’t like.”
 
“Shark Liver Oil”: On the webpage titled, “Shark Liver Oil (90 ct)”:
 
  • “In the book BELL SHARK LIVER OIL, written by four medical doctors, Dr. Hubert says that since his own high-school age children took shark liver oil as a prevention they have no more colds, whereas their school mates all have colds and flus, many a number of times each year…A 65 year old man reports he had no more colds or flus for 9 years since he started to take shark liver oil. Dr. Haimes's grand children have been taking shark liver oil for 6 months and he writes they have no infection of any kind since.”
  • “Bell shark liver oil has the highest immune-system booster, which is the key to prevent infection and illness.”
  • “It helps with inflammation type illnesses like:
  •      “Allergies”
  •      “Asthma”
  •      “Arthritis pain (in combination with Bell shark cartilage)”
  •      “Inflammation in the arteries (many doctors now say this is the main cause of heart attacks)”
  •      “Colds”
  •      “Flus”
  •      “The book says it helps:”
  •      “Diabetics”
  •      “Multiple Sclerosis (MS) sufferers”
  •      “High blood pressure”
  •      “Rashes”
  •      “Sores”
  •      “Psoriasis” 
  •      “Dermatitis”
  •      “Fungi”
 
This webpage also features claims in the form of testimonials for this product. Examples of these testimonials include the following:
 
  • Under the heading, “4 Years colds and flu free!”: “Prior to taking Bell Shark Liver Oil I had frequent colds and flus. It is the most important medicine I ever took. Flu shots did not help. It has stopped all this suffering.”
 
“Supreme Immune Booster”: On the webpage titled, “Supreme Immune Booster (90 ct)”, claims in the form of testimonials are featured for this product. Examples of these testimonials include the following:
 
  • Under the heading, “Mother was sent home to die, she is now cancer free!”:“[A customer] ordered some Bell Supreme Immune Booster Mushroom Product #52 from us and told our order desk that he gave his mother large doses of a mushroom product and his mother is cancer free now. We telephoned Joe to find out more about it. He said his mother was in the hospital with cancer of the tongue and esophagus. She had surgery and chemotherapy. After some time the doctor said they could not help her more and sent her home to die as there was no hope. This is when [the customer] came across some information about a mushroom product with different mushrooms in it including the main ingredient Coriolus Versicolor mushroom that might help her by re-activating her immune system. He bought it and gave his mother massive doses of 4 times 10 capsules per day for many weeks. There were no side effects. She gradually regained her ability to talk and got her strength back. A few months later at subsequent examinations the doctor said he can no longer detect cancer.”
  • Under the heading, “Many Bell products giving me health and vitality!”: “I then bought Bell Supreme Immune Booster #52 and I’ve not had a cold, flu or even a sniffle, while my girl friend has flus and colds.”
 
The statements listed above make clear that your products are each intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The claims cause your products to be drugs as defined by section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)].  Furthermore, your products are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling, and therefore, are new drugs as defined by section 201(p) of the Act [21 U.S.C. § 321(p)].  Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)] a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. FDA-approved applications are not in effect for your firm’s above-listed products. Thus, the introduction or delivery for introduction into interstate commerce of the above-listed products violates these provisions of the Act.
 
Furthermore, your products are offered for conditions, such as cancer, diabetes, and neurodegenerative diseases, 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 products, “Alligin,” “Astaxanthin Advantage,” “HDL Cholesterol Management,” “Coral Calcium Supreme,” “Resveratrol,” “Shark Liver Oil,” “Blood Sugar Imbalance,” and “Supreme Immune Booster” fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. These products are not exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that their labeling bear adequate directions for use because these products lack approved applications. The introduction or delivery for introduction into interstate commerce of these misbranded products violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
*          *          *
In addition to the above-listed violations, we wish to alert you to the fact that there is at least one product marketed as a dietary supplement and offered for sale on your website, “Boost Ultra,” that has been the subject of an FDA public notification because laboratory analyses conducted by FDA revealed the presence of undeclared PDE-5 inhibitors. 
 
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. We advise you to ensure that you have knowledge of the ingredients in your products before you offer them for sale.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction, and/or prosecution.
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. In addition, please provide evidence of the current status of the embargoed products and any necessary supporting documentary evidence. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
 
Please send your reply to the attention of CDR Kimberly Martin, Compliance Officer, Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207-4291. If you have any questions regarding any issue in this letter, please contact CDR Martin at 317-226-6500 extension 116.
 
 
Sincerely,
/S/ 
Glenn T. Bass
District Director
Detroit District Office