WARNING LETTER
Living Foods LLC
MARCS-CMS 622648 —
July 05, 2022
Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Bruce D. Curtis/Marianne L. Curtis
Recipient Title
Co-owner(s)
Living Foods LLC
1456 Marilee Dr.
Lawrence
,
KS
66049
United States
Issuing Office:
Office of Human and Animal Food- West Division II
United States
July 5, 2022
Reference CMS #622648
WARNING LETTER
Dear Mr. and Mrs. Curtis:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at www.livingfoodsusa.com in March 2022 and has determined you take orders for the products Bion+Plus Silver Ozone and ZeoHeal the Miracle Mineral Supplement. The claims on your website establish that these products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
We have also determined that your firm is marketing the Relax Far Infrared Ray Sauna in the United States without marketing clearance or approval, in violation of the Act. Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. 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
www.fda.gov.
Unapproved New Drugs
Your Bion+Plus Silver Ozone and ZeoHeal The Miracle Mineral 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 FDA as described in Sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Examples of some of the claims observed on the website www.livingfoodsusa.com that provide evidence that your products are intended for use as drugs include: https://www.livingfoodusa.com/Articles.asp?ID-262 and https://www.livingfoodsusa.com/Bion-Plus-SS-p/bion.htm
Bion +Plus Silver Ozone
“Bonding ozone to silver rather than O2 or O4, enables BION PLUS to duplicate the action of immune cells that make ozone to fight pathogens.”
“The molecule therefore at any chance will continue to naturally attract negatively charged electrons found in scavenging, hostile organisms, e.g., hostile, gram-negative bacteria, viruses, molds, etc., have one electron (-1) in their molecular makeup. They are therefore attracted to the Bion Plus molecules and self-destruct once they contact the Bion Plus molecules because the hostile, gram-negative release the electron from themselves, thus changing their polarity and they self-destruct in the process.”
“It is important to note that Bion Plus is not an anti-microbial product. It simply supplies unique dietary supplementation to the body in such a manner that the hostile microbes eliminate themselves naturally in the absence of a polluted, unhealthy body and the presence of a nonpolluted, healthy body containing clean and healthy water that is filled with natural elements that are uniquely designed for optimum health.”
Bion +Plus testimonials indicating how product is used
“I am a 64 year old woman and my doctor told me my immune system is compromised. However, I have gotten hit with a bug this season twice and both times I took the Bion+Plus Covalent Silver. I knocked it out in the same day with just a couple teaspoons each time. Meanwhile, all my friends have gotten the same bug and they are still battling it. This Bion+ Plus really works! Better than any other I’ve tried. I love that Bion+Plus Covalent Silver is noncolloidal and safe to use. I wouldn’t be without it. I always keep a bottle on hand.” https://wwwlivingfoodusa.com/Articles.asp?ID=258 and https://www.livingfoodsusa.com/zeohealp/zeo.htm
ZeoHeal The Miracle Mineral Supplement
“Zeolite cage can easily trap varieties of articles, working hierarchically as the article below describes: heavy metals first, then toxic chemicals, plastics, and viruses. The mineral detoxifier removes the metals and toxic molecules from the body”
“Zeolite traps and nullifies nitrosamines in the digestive track. Nitrosamines are cancer-causing agents”
“Nitrosamines are a causative factor in type-II diabetes.”
“Zeoheal *** the
ultimate heavy metal detoxifier
with a unique zeolite-fulvic acid compound
for effective and safe deep tissue cleanse of all contaminates
”
“Metal Chelator/Chlathrator Toxic Chemical Eliminator”
“Taking ZeoHeal and Bion 3x a day with much improved gut and other symptoms related to ovarian cyst removal”
“Traps and Neutralizes carcinogenic Nitrosamines”
“Exhibits broad spectrum anti-viral activity”
Misbranded Drugs
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your ZeoHeal The Miracle Mineral product is intended for prevention of one or more diseases that are not amenable to prevention by consumers themselves without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your ZeoHeal The Miracle Mineral fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Unapproved Medical Device
As stated above, the FDA has determined that your firm is marketing the Relax Far Infrared Ray Sauna in the United States without marketing clearance or approval, in violation of the Act.
FDA has reviewed your website, https://www.livingfoodsusa.com/, and determined that the Relax Far Infrared Ray Sauna is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. The Relax Far Infrared Ray Sauna is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).
Specifically, the Relax Far Infrared Ray Sauna was cleared in K053376 as an infrared lamp under 21 CFR 890.5500 with the following indications for use:
“The device may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.”
Generic devices under 21 CFR 890.5500 are intended for medical purposes that emit energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating. Devices, when classified under 21 CFR 890.5500 as an infrared therapeutic heating lamp, are exempt from premarket notification, subject to 21 CFR 890.9.
However, your firm’s website includes statements describing uses of the device for several treatments and therapies for additional medical conditions, which would constitute one or more major changes or modifications to its cleared intended use and for which your firm lacks clearance or approval. Furthermore, the uses you describe differ from the classification codified at 21 CFR 890.5500, such that premarket notification is required prior to introduction or delivery for introduction of this device into interstate commerce for commercial distribution. 21 CFR 882.9.
Examples of such statements include but are not limited to:
Cancer treatment claims -
o “Cancer patients must seek proper medical treatment. However, it is likely that medical treatment will prove more beneficial if you use the Relax FIR Sauna to improve your basic health. (2) Increased oxygen flow helps increase the growth of normal cells around the cancerous area. This is beneficial as it prohibits the spreading of cancer cells. The Relax FIR Sauna enhances oxygen delivery in the body including to the cancerous areas. Coupled with medical treatment, health improvement can be experienced.”
Kidney function medical claims -
o “The Relax FIR Sauna also improves capillary circulation, and removes excess toxins from the body thereby reducing the burden on the kidneys, helping to prevent kidney failure”
o “The Relax FIR Sauna supports kidney function by increasing excretion of uric acid, urea and toxins through your perspiration.”
o “(Remove Toxins) – Metabolism Waste – Dioxins – Cadmium & Hg – HeavyMetals – Fats”
Cardiovascular disease treatment claims –
o “The FIR Sauna effectively reduces the risk of chronic illnesses such as high blood pressure, heart problems and diabetes.”
o “FIR supports prevention of vascular sclerosis (hardening of blood vessels). Incidence of cardiovascular disease(s) will thus also decrease.”
o “People with conditions such as heart diseases and high blood pressure show marked improvement after using Relax FIR Sauna because FIR energy helps dilate their blood vessels and increase blood flow thereby unblocking and eliminating waste in the blood vessels.”
o “Relax FIR Sauna provides FIR energy, which helps reduce the size of water molecule clusters and decreases the possibility of blood coagulation; thus blood flow is smooth. Long-term usage can help to reduce the problems of viscous blood.”
Vasodilation and increased blood oxygen claims –
o “Regular use of the Relax FIR Sauna improves blood circulation by vasodilation (expansion of blood vessels) and reduces the size of water molecule clusters (more than 90% of blood plasma is water). Deep, slow and long breathing during sauna sessions will also help to increase oxygen in the blood.”
o “Relax FIR Sauna increases blood flow and dilates blood vessels. It also helps retain the elasticity of blood vessels and helps them to ’exercise’.”
o “FIR energy improves blood circulation and efficient nutrient and oxygen delivery. FIR thus promotes cell growth and cell reactivation, overcoming and preventing growth of abnormal cells, and supports good cellular maintenance.”
Chronic illnesses treatment claims -
o “Relax FIR Sauna can play a pivotal role in disease prevention and in health maintenance by activating the body to relieve degenerative disease and to avoid the fall into chronic disease.”
o “FIR absorption promotes elimination of body toxins and helps eliminate chronic illnesses.”
Dermatological condition treatment claims -
o “FIR promotes healing of acne, eczema, psoriasis, burns, skin lesions and cuts. Open wounds heal more rapidly with reduced scarring. FIR firms the skin, improving tone, texture and elasticity.”
o “The dilation of blood vessels helps in improving blood circulation and promotes elimination of toxins. Cells can also better receive and absorb nutrition; muscles and the skin regain their elasticity. Wrinkles are prevented and the skin becomes more lustrous.”
Based on the information reviewed by FDA, Living Foods’s marketing of the Relax Far Infrared Ray Sauna with the above claims, which have not been cleared or approved, raise misbranding and adulteration concerns as noted above.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
In addition, we offer the following comment:
We note that we are unable to identify whether the device covered by the above-referenced 510(k) clearance is the same as the Relax Far Infrared Ray Sauna your firm is currently marketing. We request that you provide to us in writing with your firm’s basis for determining the Relax Far Infrared Ray Sauna is the same device described in K053376.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Kara L. Roden, Compliance Officer. If you should have any questions regarding any issue in this letter, please contact Kara L. Roden, at 913-495-5121 or via email at Kara.Roden@fda.hhs.gov.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
District Director | FDA Kansas City District
Program Division Director
Office of Human and Animal Foods – West Division 2
Content current as of:
07/19/2022
Regulated Product(s)
Drugs
Food & Beverages