Inspections, Compliance, Enforcement, and Criminal Investigations

Health Research Laboratories LLC 10/09/14

  

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

Public Health Service
Food and Drug Administration
 Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128 

 

October 9, 2014
 
 
2015-DAL-WL-002
 
WARNING LETTER
 
 
UPS OVERNIGHT DELIVERY
 
 
Kramer Duhon, Managing Member
Health Research Laboratories, LLC/New World Health
433 E Las Colinas Blvd.
Suite 1290
Irving, TX 75039
 
 
Dear Mr. Duhon:
 
This is to advise you that in September, 2014, the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.hrlsupplements.com and www.rejuvaliferx.com and has determined that you take orders there for the products “AtheChel Advanced,” “Betarol,” “BioTherapex,” “Omega-3 Cardio Plus,” “RejuvaLifeRx,” and “Ultimate Health Formula,” which the websites promote 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(1)(B)]. The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, and/or prevention of disease. As explained further below, it violates the Act to introduce or deliver these products for introduction into interstate commerce and to do any act that results in these products being adulterated or misbranded while they are held for sale after the shipment of one or more of their components in interstate commerce. You can find the Act and related regulations through links in FDA’s home page at http://www.fda.gov.
 
Examples of some of the claims on your website www.hrlsupplements.com that provide evidence that your products are intended for use as drugs include:
 
On the webpage titled “Betarol”:
  • “Reduces Prostate Inflammation”
  • “Betarol …to combat the symptoms of prostatitis.”
  • “Your prostate can reduce in size up to 60%, relieving symptoms…”
 
On the webpage titled “BioTherapex”:
  • “Lower Cholesterol”
  • “Lower Risk of Diabetes”
  • “Vitamins B1, B6, B3, C and E are included… to promote infection fighting…”
  • “[P]otassium to combat osteoporosis and hypertension…”
  • “Enjoy lowered cholesterol, reduced risk of cardiovascular issues… relief from rheumatism, arthritis and osteoarthritis …”
 
On the webpage titled “Omega-3 Cardio Plus”:
  • “Unclog Arteries”
  • “Prevent Heart and Brain Disease”
  • “Lower Bad Cholesterol”
  • “Omega-3 Cardio Plus is a must have in your arsenal against heart disease and high cholesterol. It helps to eradicate decades worth of dangerous plaque buildup in your arteries, enables ideal blood pressure levels and even reduces the likelihood of terrifying chest pains or heart palpitations.”
  • “[A] regimen of Omega-3 Cardio Plus means you will start to see chronic ailments diminish…”
 
On the webpage titled “Ultimate Heart Formula”:
  • “Unclog Plaque Build Up from Arteries”
  • “Dramatically Decrease Risk of Heart Attack”
  • “The Ultimate Heart Formula…will not only recondition your heart muscles, but will… decrease the build up of dangerous plaque in your arteries.”
  • “[L]ower your risk of cardiac failure without synthetic drugs and possible side effects.”
 
On the webpage titled “RejuvaLifeRx”:
  • “Helps Regenerate Organ Tissue, Joints, and Blood”
  • “Relief from Rheumatism, Arthritis and Osteoarthritis”
  • “[E]njoy days free from the pain of rheumatism, osteoarthritis and general joint aches.”
  • “[D]ecrease cholesterol and even unclog arteries!”
  • “[H]elp combat the onset of Parkinson’s Disease, Alzheimer’s Disease and Huntington’s Disease.”
  • “[P]romotes widening of blood vessels … increased blood flow and easier erections as well as rejuvenation of the prostate.”
 
Examples of some of the claims on your website www.rejuvaliferx.com that provide evidence that your product, “RejuvaLifeRx,” is intended for use as a drug include:
 
On the home page:
  • “RejuvaLifeRx is especially good for people who are dealing with… rheumatism, arthritis, osteoarthritis… because it is an anti-inflammatory.”
  • “[It] can give relief from pancreatic conditions such as diabetes and hyperglycemia…. There are also benefits…that can help Parkinson’s, Alzheimer’s, and Huntington’s disease patients…”
  • “RejuvaLifeRx can also help keep the heart healthy by regulating hypertension…”
  • “Both female and male sexual benefits … this vitality supplement is a vasodilator…”
 
On the webpage, “How it Works,” under the heading, “Ways to Look Younger with RejuvaLife RX”:
  • “An analgesic and anti-inflammatory,..you get relief from rheumatism, arthritis, osteoarthritis…”
  • “[H]elp unclog arteries, regulate fat processing, remove atheroma plates, and decrease cholesterol.”
  • “[C]an decrease and rebalance diabetes… [P]romotes pancreatic regulation, enabling it to fulfill functions it could not otherwise have fulfilled due to hyperglycemia.”
  • “[C]ombat[s] certain degenerative diseases such as Parkinson’s, Alzheimer’s and Huntington’s.”
  • “It regulates hypertension….”
 
In addition, FDA has reviewed your reorder letter signed by Matthew Eisen, M.D. and your flyer titled “Don’t Just Take Our Word.” These materials claim that the products “The Ultimate Health Formula” and “AtheChel Advanced” can be used for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(1)(B)]. The therapeutic claims on the literature establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, and/or prevention of disease.
 
Examples of some of the claims in the letter that provide evidence that your “The Ultimate Health Formula” is intended for use as a drug include:
  • “Heart related diseases like… Heart AttacksStrokesHigh Blood Pressure… and other Arterial Life Threatening Diseases could now be an outdated thing of the past…”
  • “The Ultimate Heart Formula is the breakthrough supplement that is proven to help clear out the plaque that is endangering your heart and your life.”
  • “Eliminate deadly artery blockages…Improve your cholesterol… Lower your blood-pressure… Dissolve deadly blood-clots….Get rid of to [sic] chest-pains and palpitations… -Normalize irregular heartbeats…A Lifetime of Plaque Build Up Could Disappears [sic] In Just a Few Short Weeks. Increase Your Life Span and Quality Of Life By Up To 20 Years By Flushing Your Arteries Free Of Up To 80% Of Life Threatening Plaque!”
 
Your “Don’t Just Take Our Word” flyer also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “AthelChel Advanced” for the cure, mitigation, treatment, or prevention of disease:
  • “My carotid artery was 78% blocked on one side. One year later, after taking AtheChel Advanced, the Doppler reading showed both sides completely clear!”
 
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 introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 “AtheChel Advanced,” “Betarol,” “BioTherapex,” “Omega-3 Cardio Plus,” “RejuvaLifeRx,” and “Ultimate Health Formula” 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, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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)]. It is also a violation of section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a food or drug that causes the food or drug to become misbranded while it is held for sale after the shipment of one or more of its components in interstate commerce.
 
The 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 cause of the violations identified above 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 and FDA regulations.
 
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 and injunction. 
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps 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. If you cannot complete corrective action without fifteen working days, state the reason for the delay and the time within which you will complete the correction. 
 
Your written response should be sent to Seri L. Essary, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Dallas, TX, 75204. If you have questions regarding any issues in this letter, please contact Ms. Essary at (214)253-5335.
                                                                       
Sincerely,
/S/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director

Page Last Updated: 11/03/2014
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