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U.S. Department of Health and Human Services

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Enforcement Actions

High Performance Formulas, L.L.C. (HPF, L.L.C.) 3/22/12

  

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

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
 

Telephone: 215-597-4390 

 

WARNING LETTER
12-PHI-11
 
 
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
 
 
                                                            March 22, 2012
 
Blaine Applegate, Owner
High Performance Formulas, L.L.C.
2001 Makefield Road
Yardley, PA 19067
 
Dear Mr. Applegate:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.hpfonline.com in March 2012 and has determined that your “Statin Support 24/7 CoQ10 100mg Soft Gels,” “Green T 4,000,” “Flex Formula Caplets,”“Lyco-O-Mato Clinical Trio Softgels,” and “Cholestene” products 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)(B)]. The therapeutic 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.
 
Examples of some of the claims observed on your website www.hpfonline.com include:
 
Statin Support 24/7 CoQ10 100mg Soft Gels:
  •  “Statin drugs work to manage cholesterol”
Green T 4,000:
  •  “Green T 4,000 is an exclusive green tea extract containing 98% polyphenols, a green tea component with antioxidant properties. [P]olyphenol compounds in tea, especially green tea, are powerful antioxidants with cancer fighting properties and cholesterol balancing capabilities.”
  • “[C]ertain polyphenols can inhibit the growth of colon and breast cancer cells without affecting similar cells that are not cancerous.”
Flex Formula Caplets:
  • ““HPF’s FLEX FORMULA is a proprietary blend of Glucosamine 500mg, Chondroitin 400mg, and MSM 500mg. Those three ingredients…help ease symptoms of osteoarthritis…”
Lyc-O-Mato Clinical Trio Softgels: (Sold under Healthy Origins Brand Label)
  •  “[L]ycopene [an ingredient in your product] in combination with other synergistic phytonutrients, that is most beneficial to those at risk for prostate cancer.”
On the webpage titled, “Cholesterol Facts’:
  •  “Cholesterol levels can be lowered by combing exercise with a low-fat diet, and by taking the dietary supplement Cholestene twice a day.”
  •  “Cholestene is an all natural dietary supplement formulated with red yeast rice which has been proven to have compounds powerful enough to help the body maintain normal cholesterol levels by blocking the production of LDL (bad) cholesterol.”        
  • “With over 34 clinical studies performed…proving the safety and efficacy of Red Yeast Rice [an ingredient in your product], it’s considered a leading alternative to pharmaceutical products for cholesterol management.”
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 “Statin Support 24/7 CoQ10 100mg Soft Gels,” “Green T 4,000,” “Lyco-O-Mato Clinical Trio Softgels,” and “Cholestene” 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 layman can use these drugs safely for their intended uses. Thus, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their 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)].
 
The above violations cited in this letter are not meant to be an all-inclusive list of violations in your products and their labeling. It is your responsibility to ensure that all products marketed and distributed by your firm comply with the Act and its implementing regulations. We advise you to review your website, products labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act. 
 
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334]. 
 
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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
 
Your response should be sent to Yvette Johnson, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Johnson can be reached at 215-717-3077 or Yvette. Johnson@fda.hhs.gov.
 
                                                                       
Sincerely,
/S/ 
Kirk Sooter
District Director
Philadelphia District
 
 
cc:       
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Acting Director