Inspections, Compliance, Enforcement, and Criminal Investigations

Vitamins Direct (USA), Inc. 10/17/14

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-15-01
October 17, 2014
 
Melissa A. Pait, Head of Operations
Vitamins Direct (USA), Inc. and Golden Pride, Inc.
2540 Metrocentre Blvd., Suite 5
West Palm Beach, FL 33407-1955
 
Dear Ms. Pait:
 
From August 9, 2013 to August 14, 2013, the U.S. Food and Drug Administration (FDA) inspected your facility, located at 2540 Metrocentre Blvd., Suite 5 West Palm Beach, FL 33407 from which your firms, Vitamins Direct (USA) and Golden Pride, Inc. distribute your products, including dietary supplements under the Flexezy and Physician’s Signature brands.   
 
We reviewed your website at www.vitaminsdirectonline.us in July 2014 and determined that you take orders there for the products Pulsate Plus, Lipid Results, OC-Max, Cardio Results Omega III, Flexezy FLX, Flexezy-GC, Honey Bee Propolis and Glyco Results which the website promotes 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 the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
 
Unapproved New Drugs
 
As stated above, we reviewed your website at the Internet address www.vitaminsdirectonline.us in July 2014 and determined that your products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)].
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Pulsate Plus
  • “It has also been reported by past customers to have virtually eliminated their rosacea and lowered their blood sugar levels enabling them to cut their usual insulin doses in half!”
  • “NatraStatinTM plant sterols…reduce the risk of heart disease and lower cholesterol levels…”
  • Pulsate Plus has been known to help reduce the risk of heart disease and lower Total and LDL Cholesterol.”
 
Lipid Results
  •  “Lipid Results is a doctor-formulated, cutting-edge supplement designed to help manage your…blood pressure.”
  • “[G]uggul gum extract can aid in the treatment of arthritis, skin diseases...Garlic's added benefits include providing antibacterial, antiviral, and antifungal properties while aiding in the prevention of heart disease and high blood pressure.”
  • “Other key ingredients found in Lipid Results are…fenugreek seed which may help in controlling diabetes and arthritis….”
  • “The ingredients found in Lipid Results…contribute to lowering your cholesterol.”
  • “High cholesterol is a serious condition that increases your risk of heart disease. Fortunately there are easy steps you can follow to lower your cholesterol level and protect your health. Lipid Results is a doctor-formulated, cutting-edge supplement designed to help manage your cholesterol.”
 
OC-MAX
  • “Provides anti-inflammatory effects.”
  • “[S]errazymes may be used to help dissolve blood clots, arterial plaque…”
  • “OC-MAX combines the incredible benefits of plant sterols, SerrazymesTM, and three proven chelators, sodium alginate, S.H.M.P. and EDTA to offer the best non-invasive chelation and proven natural cholesterol reduction.”
 
Cardio Results Omega III
  •  “It has been reported by past customers to have virtually eliminated their rosacea and lowered their blood sugar levels enabling them to cut their usual insulin doses in half!”
 
Flexezy-GC
  • “Flexezy-GC…is great for those suffering from conditions such as…arthritis, bursitis, osteoarthritis, and rheumatoid arthritis…”
 
Honey Bee Propolis
  • “Honeybee Propolis can help build the body's natural resistance to infections and diseases while offering strong antibiotic, antiseptic, antiviral, anti-fungal, and anti-inflammatory properties.”
  • “Helps regulate histamine and seratonin [sic], two substances needed by the body to help cope with allergies, hay fever....”
  • “Bee Propolis: Propolis, also known as “Russian Penicillin,” has been proven to show antibiotic, antiseptic, antiviral, anti-fungal, and anti-inflammatory properties.”
 
Glyco Results
  • “Physician's Signature Glyco Results is a doctor-formulated, cutting-edge blood sugar management supplement.”
  • “Gymnema Sylvestre Leaf Extract: - Helps support healthy blood sugar levels and…also possesses antiviral and lipid lowering properties”
  • “Chromium: Helps stabilize blood sugar levels, improve insulin function, and manage diabetes”
  • “Vanadium: Plays a role in glucose metabolism and mimics the effects of insulin…”
 
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 the 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 Lipid Results, Cardio Results Omega III, Honey Bee Propolis and Glyco Results 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)].
 
Misbranding
 
Even if your OC-Max product was not an unapproved new drug, it would still be a misbranded dietary supplement within the meaning of section 403 of the Act [21 U.S.C. § 343] because the labeling bears an unauthorized health claim in violation of 403(r)(1)(B) of the Act [21 USC § 343(r)(1)(B)]. Specifically, the labeling of this product bears the claim “May reduce the risk of heart disease” but does not meet the requirements to make such a claim. Under section 403(r)(1)(B) of the Act, a health claim in food labeling must be made in accordance with a regulation authorizing the use of this claim.
 
FDA has issued a regulation specifying the criteria for the use of a health claim for plant sterol/stanol esters and the risk of coronary heart disease (CHD) (21 CFR 101.83). For example, the requirements for the use of this health claim include specific statements the claim must make, including that plant sterol/stanol esters should be consumed as part of a diet low in saturated fat and cholesterol (21 CFR 101.83(c)(2)). However, your claim fails to contain the required language for the health claim. Thus, the use of the claim “may reduce your risk of heart disease” misbrands your product under section 403(r)(1)(B) of the Act. The introduction of a misbranded dietary supplement into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)]. 
 
We note that FDA published a proposed rule to amend the health claim for plant sterol/stanol esters and risk of CHD, in which FDA stated, “Pending issuance of a final rule, FDA intends to consider the exercise of its enforcement discretion on a case-by-case basis when a health claim regarding phytosterols is made in a manner that is consistent with the proposed rule.” (77 Fed. Reg. 76526 at 76546, December 8, 2010). In February 2012, FDA further explained its intent to consider the exercise of its enforcement discretion with respect to the use of the health claim for phytosterols and risk of CHD (77 Fed. Reg. 9842, February 21, 2012).
 
(b)(3)
 
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
 
(b)(3)
 
The violations cited in this letter are not meant to be an all-inclusive list of violations that exist in connection with your products or their labeling. 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 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 but not limited to seizure and/or injunction.
Please send your written response to Randall L. Morris, Compliance Officer, U.S. Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions with regard to this letter, Mr. Morris can be reached at 407-475-4741 or Randall.Morris@fda.hhs.gov.
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District
 
 
Cc: William E. Hudson, Chief Financial Officer
 

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