| Public Health Service Food and Drug Administration |
Southwest Region |
Department of Health and Human ServicesSeptember 19, 2011
Ref: DEN-11-20 WL
WARNING LETTER
VIA UPS
Mr. Steven Frank
Nature's Rite, LLC
1531 Skyway Drive
Unit A
Longmont, CO 80504
KlearLabs
7124 Pinecone Ct.
Niwot, Colorado 80503
Dear Mr. Frank:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites, www.mysleepapneacare.com and www.mynaturesrite.com, in July 2011 and has determined that your products Sinus SupportTM, Respiratory Relief TM, Sinus ReliefTM, Sinus TrilogyTM, Joint ReliefTM, Super Neti Juice™, Herpes ReliefTM, and Shingles Relief TM are promoted for conditions that cause these 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 claims on your websites establish that these products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans. The marketing of your product with these claims violates the Act.
Your website www.natures-rite-remedies.com redirects consumers to another website of yours, www.mynaturesrite.com. that makes numerous disease claims.
Examples of some of the claims observed on your website www.mynaturesrite.com include:
• From product links regarding "Sinus Relief TM": "A balanced, broad-spectrum anti-microbial"
• "Netipots just rinse, Sinus Relief disinfects"
• "Kills fungus, bacteria, and virus"
• "[Y]ou need something that kills bacteria and fungus ... You need Sinus Relief TM"
• "kills bacteria only where you spray it ...
From a products link regarding "Sinus SupportTM":
• "Grapefruit Seed Extract is a natural anti-microbial ... "
From a products link regarding "Sinus TrilogyTM":
• "Nature's Rite Sinus TrilogyTM is clinically proven to be effective treatment for Sinusitis!" "Rid yourself of sinus infections"
• "Nature's Rite Sinus TrilogyTM products can kill the bacteria, fungus, and virus causing your sinus infection."
From a products link regarding "Joint Relief TM":
• "Nature's Rite Joint Relief was created to treat the cause of joint pain ..."
• "Devil's Claw, Celery Seed, and Poke Root [ingredients in your product] have major anti-inflammatory power, especially for sufferers of rheumatoid arthritis."
• "Frankincense [an ingredient in your product] also acts as an anti-inflammatory"
• "Arnica Montana, White Willow Bark, and Feverfew [ingredients in your product] act as analgesics"
• "Comfrey and Arnica [ingredients in your product] repair soft tissues and smooth moving surfaces, an important process that relieves stiffness and increases mobility in arthritis sufferers"
• "Peppermint [an ingredient in your product] contains menthol, which relieves joint pain ... a powerful muscle relaxer"
• "Nature's Rite Joint Relief is a roll-on topical treatment for joint inflammation. It is a highly effective arthritis treatment ... "
From a products link regarding "Respiratory Relief TM":
• "Respiratory Relief is a power broad-spectrum antimicrobial agent."
• "Anti-Fungal"
• "Anti-Viral"
• "Anti-Bacterial"
• "Respiratory Relief works by killing fungus, bacteria and virus. By breathing it in, it lands directly on top of the colonies that are forming within your lungs and kills the invading microbes directly ... "
• "[T]he combination of these components [silver colloid and polysorbate 20-ingredients in your product] is deadly to bacteria, fungus and virus."
• "Breathing several milliliters of Respiratory Relief several times per day reduces the microbial load dramatically over the course of several days."
• A few days [use of your product] is all that is required to dispatch a common case of bronchitis. For chronic cases such as MAC (Non-tuberculous [sic] Mycobacterium) significant on-going improvement has been demonstrated over 6 months of clinical study. Long-term use for these conditions has shown better improvement than the antibiotic regimens and no side-effects."
From a products link regarding "Shingles Relief TM":
• "Get rid of Shingles and PHN pain and heal your skin quickly!"
• "Relieve Pain & Inflammation"
• "Antimicrobial & Antiviral Support"
• "Reduces Blistering"
• "Nature's Rite Shingles Relief works in three ways to rid you of Shingles and heal your damaged skin."
• "Shingles Relief ... addresses the shingles symptoms, ... attends to the virus and heals the skin with a complex, ... yet simple mix of all natural ingredients."
• "Shingles Relief not only takes care of shingles pain and heals the skin, but for those 40% of people who get Shingles and then develop PHN, Shingles Relief will relieve that lingering pain too. The three functions of antiviral support, PHN symptom relief and bodily healing are all included in Shingles Relief."
• "Shingles Relief contains herbs such as White Willow and Lavender that reduce inflammation and pain and relax the nerves irritated by the outbreak of shingles."
• "Herbs like Poke and Lemon Balm [ingredients in your product] are anti-viral and anti-herpetic so they are able to give your immune system an advantage in fighting off the virus."
• "Skin damage and even scarring can occur during a bout of shingles because your immune system targets and destroys infected skin cells. Herbs like Calendula, Chickweed and Comfrey [ingredients in your product] help the skin heal and can reduce the severity of scarring."
• "Shingles Relief™ contains":
• "Poke: anti-viral"
• "Arnica: Relieves shingles pain and promotes healing"
• "Willow: Alleviates pain"
• "Comfrey: ... [H]eals damaged tissue"
• "Charparral: Anti-viral support"
• "Lemon Balm: Herpes fighting action"
• "Meadowsweet: Relieves skin initation"
• "Humic Acid: Antiviral support"
From a products link regarding "Super Neti Juice™'':
• "Super Neti Juice: is used the same as traditional neti pot solutions, but has all the anti-microbial power of prescription medication--but none of the side-effects! Super Neti Juice will get you the results you desire without the complications of surgery and unlike antihistamines, attacks the root of the problem: all those infectious microbes that seek to infest your sinuses."
• "Super Neti Juice is so effective because it harnesses the potent-but-safe antimicrobial known as silver colloid--which is able to destroy both the bacteria and the fungi that cause sinusitis. Because you apply a concentrated dose to your sinuses, you won't have to worry about killing off any beneficial bacteria--only the bacteria that cause the problem. And because you are killing the fungi as well, you are helping your immune system regulate the microbe populations inside your nose--keeping a healthy balance between bacteria and fungi levels and crushing sinusitis at the source!"
From a products link regarding "Herpes Relief TM":
• "How it Works: Herpes Relief uses powerful herbs in a three-pronged approach First: Analgesic and Nerve Quelling herbs Relieve the Pain and Itch. Next: Strong Anti-Virals stop the out break. Finally: Restorative herbs speed the healing process"
• "Herpes ReliefTM is the only natural product that blends all these action into one potent lotion. You can coat the sores directly for on-the-spot relief."
• "Closes Lesions Fast!"
• "Relieves Pain and Itch on Contact!"
Your website also contains disease claims in the form of personal testimonials including:
From a products link regarding "Super Neti Juice"
• "I have been using the Sinus Trilogy products, as I have suffered numerous sinus infections, just chronic, since 1994.. .I have been taking antibiotics 3 or 4 time[s] a year trying to treat the infection. The sinus trilogy was the first product I've tried that is all natural and it's absolutely wonderful. The Sinus Relief that kills the bacteria and fungus is absolutely phenomenal. I've had excellent results."
• "I been using the Nature's Rite Sinus Relief, and it has been helping me breathe better. It got rid of my sinus infection and I really enjoy oy the product!"
• "I had nasal allergies for five years ... I got online ... and found the sinus relief and the sinus trilogy. I LOVE IT! I can breathe freely and I don't have to use other nasal sprays. I'm absolutely thrilled with it."
From a products link regarding "Herpes ReliefTM":
• "After a period of very intense emotional duress, I had a Herpes eruption on the tip of my penis. It was blistering and painful. The last time this happened the blisters were there for a week before healing even began. My friend gave me a little tub of Herpes Relief from your Nature's Rite company and even though it looked strange I tried it. Wow. That's all I can say is Wow. The blisters dried up in one day and were mostly healed and gone a couple of days later. I don't EVER want to be without this stuff."
From a products link regarding "Sinus ReliefTM":
• "After two sinus surgeries years ago, my sinuses were a mess. I could barely breathe. Then, after two bottles of your Sinus Relief, I am now FINALLY free of Sinusitis! I can't believe how something so simple can works so well, but it does. Thank-You so much for this product.11
• "They are better than anything I have purchased in a drug store! I can use as much as I want and not worry about becoming addicted to it!"
Furthermore, the disease claims quoted above are supplemented by the metatags you use to bring consumers to www.mynaturesrite.com. The metatags include:
• "sleep apnea treatment," "herpes, .,. sinus relief, ... sinus trilogy, hemorrhoid relief, ... restless legs, ... sinus infections, sinusitis, hemorrhoids, '" asthma,"
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, 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 Sinus Support™, Congestion ReliefTM Sinus ReliefTM, Complete Sinus TrilogyTM, Joint ReliefTM and Super Neti Juice™, 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, your products are misbranded within the meaning of 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 above violations are not meant to be an all-inclusive list of violations. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
In addition to the violations discussed above, we have the following comment. We note the facebook account at httos://www.facebook.com/pages/Natures-Rite-Natural-Remedies/
110124735682379#!/pages/Natures-Rite-Natural Remedies/110124735682379?sk=wall makes disease claims. Specifically, the website states that "Sinus Care Products" are "designed to defeat sinus infections and prevent allergies."
You should notify this office in writing within fifteen (15) working days of receipt of this letter. Your response should include each step taken or that will be taken to correct the violations and prevent recurrence. You should include in your response any documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for the delay and state when you will correct any remaining violations.
Your response should be directed to Thomas R. Berry, PharmD, Compliance Officer, Food and Drug Administration, Denver District Office, Building 20 - Denver Federal Center, 6th Avenue & Kipling Street, Denver, Colorado 80225-0087. If you have any questions regarding this letter, please contact Dr. Berry at 303-236-3028.
Sincerely,
/s/
Ann M. Adams, PhD
Denver District Director (Acting)
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