| Public Health Service Food and Drug Administration |
Florida District |
Department of Health and Human Services
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
FLA-11-22
March 28, 2011
Saw Palmetto Harvesting Co. (Corporate Office)
Mr. Gerald Walter Gettel, Owner
1969 310 Ave.
Lengby, MN 56651
Saw Palmetto Harvesting Co. (Processing Plant)
Mr. Gerald Walter Gettel, Owner
4000 Hwy 27
Frostproof, FL 33843
Re: FEI: 3006524173 (Corporate office)
FEI: 3008550053 (Processing Plant)
Dear Mr. Gettel:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed several websites owned by your firm, Saw Palmetto Harvesting Company, in October 2010. Based on our review of your websites at the Internet addresses www.sawpalmetto.com and www.redroosterpills.com. we have determined that the products "Saw Palmetto" and "Red Rooster Pills" 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 websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.
Examples of some of the claims observed on your websites include:
• "Saw Palmetto ... is marketed to the general public mainly as a treatment for Benign Prostatic Hyperplasia or BPH."
• "Saw Palmetto clinical studies
A long-term study of 150 men with clinically diagnosed BPH and complaints of prostatic symptoms has demonstrated 'the long-term efficacy and tolerability of Permixon and support its use as a first-line medical therapy for uncomplicated symptomatic BPH.' Permixon is a brand of standardized saw palmetto ...."
• "Natural Remedy for Erectile Dysfunction"
• "Red Rooster Pills, the leading Herbal Viagra Alternative"
• "Red Rooster Pills, the all natural viagra alternative brings us to the dawn of a new era. Men suffering from erectile dysfunction, impotence ... no longer have to go untreated."
Your products "Saw Palmetto" and "Red Rooster Pills" are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p)(1) of the Act [21 U.S.C. § 321(p)(1)]. 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, because your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, the labeling of these products fails to bear adequate directions for their intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [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)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that it contained links to multiple other websites on which you promote other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your websites were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product 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 of the 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 in the future. 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. If you need additional information or have questions concerning any products distributed through your websites, please contact Carla Norris in writing at 555 Winderley Place, Suite 200, Maitland Florida 32751, or via telephone at (407) 475-4730.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District
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