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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pacific Standard Distributors, Inc 1/23/14

  

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

Public Health Service
Food and Drug Administration
 
Seattle District
Pacific Region
22215 26th Ave SE, Suite 210
Bothell, WA 98021-4425
 
Telephone:      425-302-0340
FAX:    425-302-0402 

 

January 23, 2014
 
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
 
In reply, please refer to Warning Letter, SEA 14-04
 
Mr. Bajanov Vladimir
President
Pacific Standard Distributors, Inc.
34480 SE Colorado Road
Sandy, Oregon 97055
 
WARNING LETTER
 
Dear Mr. Vladimir:
 
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.modifilan.com in January 2014, and has determined that you take bulk orders for the product “Modifilan” and offer free samples of the product at phone numbers listed on the website. The website promotes “Modifilan” for conditions that cause the product to be a drug 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 product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering “Modifilan” for introduction into interstate commerce for such uses violates the Act.
 
Examples of the website claims that provide evidence your product is intended for use as a drug include:
 
On the page titled, “About Our Product:”
 
  • “Fucoidan … [a substance in the product] causes certain types of rapidly growing cancer cells to self-destruct. Promoting apoptosis (self-destruction of cancer cells), Fucoidan helps to naturally eliminate harmful cells from organism.”
  • “Laminarin [a substance in the product] is a polysaccharide helpful in the prevention and treatment of cardiovascular diseases.”
  • “What does MODIFILAN do? … Can help protect against thyroid cancer and other cancers…Helps to decrease high blood sugar and cholesterol levels.”
 
On the page titled, “Scientific Data:”
 
  • “The ongoing research into Fucoidan [an ingredient in your product] has conclusively demonstrated its ability to induce cancer cell apoptosis (programmed cell death) in leukemia, stomach and colon cancer cell lines.”
  • “…Modifilan one of the richest sources of cancer-fighting Fucoidan.”
  • “Another polysaccharide concentrated in Modifilan that may have anti-cancer properties is laminarin.”
  • [N]ovel approach to tumor therapy based on blocking angiogenesis.”
  • “Fucoidan interferes with cancer cells metastasis (anti-metastatic activity)…”
  • “Fucoidan, a sulfated fucopolysaccharide, inhibits the adhesion process…and therefore interfering with tumor cell colonization (metastasis).”
  • “Another mechanism of antiproliferative (anti-tumor) properties of Fucoidan was shown in vitro and in vivo on a cell line derived from a nonsmall-cell human bronchopulmonary carcinoma…”
  • “This suggests another aspect of antitumor activity of Fucoidan related to the activation of macrophage-mediated tumor cell killing.”
  • “There are also non-polysaccharide fractions from Laminaria that have been found to have significant cancer-preventative anti-mutagenic (anti-DNA damage) activity against typical genotoxic substances.”
  • “Another promising use of the sulfated polysaccharides Fucoidan and laminarin is in the prevention and treatment of cardiovascular disease.”
  • “[C]an be useful in the prevention and treatment of hyperlipedemia. Laminarin has been shown to have a hypotensive effect. It also exhibits 30% of the anticoagulant activity of heparin.”
  • “All of these properties…make Modifilan clinically applicable in the prevention and treatment of coronary heart disease, cerebrovascular disease, atherosclerosis, cancerogenesis, and cancer metastasis.”
  • “Polysaccharide laminarin has been shown in four animal species…to prevent acute radiation sickness and death…when administered within 24 hours after radiation exposure. This research suggests that the brown seaweed Laminaria can be clinically useful in the treatment and prevention of the adverse effects of ionizing radiation.”
  • “Another interesting potential application of Modifilan as one of the best sources of Fucoidan is for inflammatory conditions of the alimentary tract.”
  • “Since Fucoidan shares many properties with heparin…one can expect similar therapeutic benefit with use of Fucoidan.”
 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Modifilan” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
On the page titled, “Doctors Testimonials:”
 
  • “It is needless to say that Modifilan would affect and lower cholesterol (LDL), regulate blood sugar and exert different anti-viral and anti-cancer effects.”
  • “There is interesting potential application of Modifilan…for inflammatory conditions of the alimentary tract.”
 
On the page titled, “Customers Feedback:”
 
  • “[D]etoxifies dangerous heavy metals such as lead, mercury, cadmium, cobalt, and radium. Modifilan…inhibits growth of tumor cells…is an anti-viral and anti-cancer agent.”
 
The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches.  These metatags include: “cancer,” “hypothyroidism,” “diabetes,” “hashimoto’s,” “autistic,” “depression,” and “protect against cancer.”
 
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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.  
 
Your product is 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 this drug safely for its intended purposes. Thus, your product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the 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 violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. 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. 
 
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 (15) 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 that would assist in evaluating your corrections. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction.
 
Please send your written response to the attention of Patricia Pinkerton, Compliance Officer, Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions regarding this letter, please contact Patricia Pinkerton at (425) 302-0428.
 
                                                                             
Sincerely,
/S/                                                           
Kate Bent, Ph.D.
Acting District Director