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WARNING LETTER

Earth Turns, LLC MARCS-CMS 566232 —

Product:
Dietary Supplements

Recipient:
Recipient Name
Thomas Scheiber
Earth Turns, LLC

16363 Wynncrest Falls Way

Chesterfield, MO 63005
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


WARNING LETTER

 

VIA OVERNIGHT DELIVERY

RETURN RECEIPT REQUESTED

 

February 5, 2019

 

Earth Turns, LLC

Attn: Thomas Scheiber

16363 Wynncrest Falls Way

Chesterfield, MO 63005

 

RE: 566232

 

Dear Mr. Scheiber:     

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.earthturns.com in September and October 2018 and has determined that you take orders there for the products Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, and Fundamental Omega-3. 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. 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.  

Examples of some of the claims observed on your websites that provide evidence that your products are intended for use as drugs include the following:

On the webpage titled, “Can Green Tea Help Alzheimer’s Disease?”: 

  • “There are a number of ways to help reduce your risk of developing Alzheimer’s disease, and one of the best natural ways to support healthy cognitive function and to fight Alzheimer’s disease is with a green tea supplement.”
  • “Green tea may also help to reduce the occurrence of Alzheimer’s disease.”
  • “Green tea also works to block the proteins that can cause plaque to develop and lead to Alzheimer’s disease.”
  • “Studies have shown that green tea supplements may help to fight the accumulation of proteins that can lead to Alzheimer’s disease.

On the webpage titled, “Pure Encapsulations – Green Tea Extract (Decaffeinated)”: 

  • “Green tea extract may also help to regulate blood sugar and reduce the risk of type 1 diabetes.” 

On the webpage titled, “How Can I Improve My Memory?” for an ingredient found in your Cogni-Flex product: 

  • “Huperzine A is another supplement, known as Chinese club moss. It works just as Alzheimer’s drugs work, but naturally and without side effects.”

On the webpage titled, “Omega 3 Benefits Stroke – Fish Oil Supplement May Help”: 

  • Fish oil supplements have been shown to have anti-inflammatory effects in diseases such as cancer, asthma, rheumatoid arthritis, osteoporosis, dry eye disease, age-related macular degeneration, coronary heart disease and sepsis.”
  • “The use of fish oil supplements as a protective factor against stroke and other neurological diseases such as Alzheimer’s has been suggested.”

On the webpage titled, “DC Labs – GlucoFit 48mg” under the subheading, “GlucoFit by Dee Cee Labs – Herbal Remedy for Diabetes Control”: 

  • “GlucoFit contains an active ingredient…extracted from the leaves of the plant Lagerstroemia speciosa. These leaves are often used in Southeast Asia as an herbal remedy for diabetes and a number of other disorders, including obesity.” 

The claim quoted above is supplemented by metatags used to bring consumers to your website through Internet searches. The metatags are:

  • “GlucoFit is the natural diabetes supplement that contains corosolic acid. This amazing ingredient has been shown in research to reduce blood sugar levels. Start balancing your blood sugar levels today with this herbal remedy for diabetes.”
  • "Natural Diabetes Supplement”
  • “herbal remedy for diabetes…natural insulin” 

On the webpage titled, “Fundamental D3 1000”:

  • “ALL cancers can be lowered by 77 percent with high vitamin D levels”
  • “…[V]itamin D has potential applications to many different immune conditions, from cancer to immune deficiency.”

Finally, claims made on your Facebook page, www.facebook.com/earthturns, which links to your website www.earthturns.com where your products can be purchased directly, provide further evidence that your products are intended for use as drugs. For example:

  • A February 25, 2016, post, “What can help with our memories and protect against degenerative diseases such as Alzheimer's? This article offers a few natural supplements that may help!” with a link to the webpage, “How Can I Improve My Memory” on your website.
  • An April 3, 2013, post, “Did you read our blog Green Tea extract may help play a role in preventing Alzheimer's” with a link to the webpage, “Pure Encapsulations Green Tea Extract (decaffeinated) - Made in USA - 120 Capsules” on your website.”

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 FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

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 C.F.R. § 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 products Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, and Fundamental Omega-3 are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Green Tea Extract, Cogni-Flex, GlucoFit 48mg, Fundamental D3 1000, and Fundamental Omega-3 fail to bear adequate directions for their intended use and, therefore, the products are 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 these misbranded drugs violates 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 products. 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 all products marketed by your firm comply with all requirements of federal law, including 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/or injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your written reply should be directed to Shawn Goldman, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.

 

Sincerely,

/S/

William A. Correll, Jr.

Director

Office of Compliance

Center for Food Safety and Applied Nutrition 

 

 

cc:

Earth Turns, LLC

PO Box 4232

Chesterfield, MO 63006

 

Earth Turns, LLC

624A Goddard Ave.

Chesterfield, MO 63005