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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Realm Labs, LLC 4/11/13

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
WARNING LETTER
 
FLA-13-17
 
April 11, 2013
 
Richard H. Mann
President
Realm Labs, LLC
258 SE 6th Avenue, Suite 5
Delray Beach, FL 33483
           
 
Dear Mr. Mann:
 
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the internet addresses www.realmlabs.net and www.neuremedy.com (which redirects to www.realmlabs.net) in March 2013, and has determined that your NeuRemedy products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act), as discussed further below. You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
 
Specifically, your NeuRemedy products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the labeling for these products is false or misleading in that they are labeled and marketed as medical foods but do not meet the statutory definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria set forth in 21 CFR 101.9(j)(8). The Orphan Drug Act defines “medical food” as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The regulation in 21 CFR 101.9(j)(8) sets forth criteria to clarify the statutory definition of a medical food. Specifically, this regulation provides that a food is a medical food only if:
 
i.    It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding tube;
 
ii.    It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
 
iii.    It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
 
iv.    It is intended to be used under medical supervision; and
 
v.    It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
 
FDA considers the statutory definition of “medical food” to narrowly constrain the types of products that fit within this category.[1] In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision.[2] Patients with such a disorder, disease, or condition must have a limited capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or have other special medically determined nutrient requirements, which cannot be managed by the modification of the normal diet alone.[3] Medical foods are not those simply recommended by a physician as part of an overall diet to reduce the risk of a disease or condition.[4] As discussed further below, your NeuRemedy products do not meet the regulatory criteria for a medical food.
 
Pursuant to 21 C.F.R. 101.9(j)(8)(ii), a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. While your labeling states that the patients for whom your NeuRemedy products are intended have low levels of the micronutrient thiamine, FDA is not aware of any evidence that patients with neuropathy have a limited or impaired capacity to ingest, digest, absorb, or metabolize thiamine, or other nutrients, or have a distinct requirement for thiamine or any other nutrient. 
 
Because your NeuRemedy products are intended to support a condition, neuropathy, that does not have distinct requirements for certain nutrients, these products do not meet the regulatory criterion for medical foods set forth in 21 C.F.R. 101.9(j)(8)(ii). Accordingly, these products are misbranded within the meaning of Section 403(a)(1) of the Act because their labeling is false or misleading in that the products are labeled as a medical food but do not meet the definition of a medical food.
 
Unapproved New Drug
 
Because your NeuRemedy products are labeled and marketed as medical foods, but do not meet the statutory definition of a medical food, FDA has determined that these products are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. 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 web sites www.realmlabs.net and www.neuremedy.com are as follows:
 
Under the Home tab:
 
  • “NeuRemedy® – The Neuropathy Vitamin™
  • “Improve The Symptoms of Pain, Burning, Numbness & Tingling with NeuRemedy® “The Neuropathy Vitamin™””
 
NeuRemedy (60 count and 120 count)
 
  • Claim on label provided as image on webpage: “Specially formulated for the nutritional management of periphal neuropathy including pain, burning, tingling and numbness in the feet and legs”
  • “Neuroemedy … that nourishes dysfunctional nerves allowing them to conduct impulses more normally” …. “used … to successfully help tens of thousands of patients suffering from peripheral neuropathy in Asian and Europe.”
 
Under the How NeuRemedy Works tab:
 
  • “NeuRemedy … nourishes nerves affected by peripheral neuropathy and allows them to conduct impulses more normally. The active ingredient in NeuRemedy … has demonstrated remarkable results in easing the symptoms of pain, burning, numbness and tingling in patients with peripheral neuropathy.”
  • “Benfotiamine has been used since the early 1960’s to successfully help tens of thousands of patients suffering from peripheral neuropathy worldwide.”
  • “[P]eople suffering from peripheral neuropathy have low levels of this essential micro-nutrient. …. They need a more bioactive form of thiamine for their nerves to function properly. This population includes, but is not limited to, the elderly, people with diabetes, and patients on certain medications. For these people, NeuRemedy nutritionally manages their peripheral neuropathy by delivering a highly bioactive form of the micro-nutrient thiamine to where it is needed, the nerve cells.”
  • “In the case of periphal neuropathy, patients may need the highly bioactive form of thiamine found in NeuRemedy in order to nutritionally manage their neuropathy.”
 
Under FAQ tab:
 
  • “Who is likely to be helped by NeuRemedy?
Diabetics and other people suffering burning, tingling, numbness, and/or shooting pains in their feet, legs, or hands”
 
  • “Does NeuRemedy actually repaid the nerves?
NeuRemedy causes the nerves to function properly again…”
 
  • “Can I use NeuRemedy if I’m not diabetic?
Yes, NeuRemedy often helps people who suffer from neuropathy even if they are not diabetic”
 
  • “Does NeuRemedy affect my need for prescription medications?”
Some people find that after they have started taking NeuRemedy they can eliminate or reduce the amount of prescription medicines they take for their neuropathy”
 
In addition, your websites contain disease claims in the form of personal testimonials which establish that these products are intended for use as drugs. For example:
 
Under the Success Stories tab:
 
Darlene – Diabetic Patient
 
“I was diagnosed at the age of 7 as an insulin dependent type 1 diabetic. So for 38 years I have been living the diet, exercise plan, and doing the best I can, but complications do happen. And about four years ago I began experiencing the results of peripheral neuropathy, pain, tingling, numbness in my feet. And then about two years ago I started taking NeuRemedy, and I found after two months of taking this, that the pain and numbness went away.
 
It's part of my daily regimen. I take it as I take my insulin and my vitamins twice a day, and it really has made a difference. … there's no swelling, there's no pain and there's no numbness. So NeuRemedy has a made a difference in my life.”
 
Don- Neuropathy Patient
 
“And since I tried NeuRemedy, I find that I'm not being woken up by the pain in my toes, and I seem to be getting some feeling back in my toes after an accident. But the NeuRemedy seems to be working on me. I can't say it went away all the way, but it's gone away a lot. … I still have neuropathy, but I also am getting some feeling back. So if it works that way, it's the first thing in 10 years that has ever worked.”
 
Howie – Neuropathy Patient
 
“Well, basically I felt like I would have like a tendency to possibly fall or trip and lose my balance and it was numbness in my feet. And by taking this Neuremedy, it helped all the symptoms of me not feeling I'm falling or the numbness disappeared.”
 
Tom – Neuropathy Patient
 
“The pain that I've had for a number of years has been alleviated but not completely cured from me taking of this NeuRemedy. … I have diabetic neuropathy. And it has improved, there's no question about it.”
 
Your NeuRemedy 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 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. Additionally your NeuRemedy products are misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
 
This letter is not intended to be an all-inclusive review of your websites and the products your firm distributes. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations. We may take further action if you do not promptly correct these violations.  For instance, we may take further action to seize your products and/or enjoin your firm from operating.
 
Please respond in writing within fifteen (15) days of receipt with the actions you plan to take in response to this letter. If you need additional information or have questions concerning this letter, 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


[1] See 56 Fed. Reg. 60366, 60377 (Nov. 27, 1991); see also Guidance for Industry: Frequently Asked Questions About Medical Foods, May 2007.
[2] See 21 U.S.C. § 360ee(b)(3); see also 56 Fed. Reg. at 60377.
[3] See 21 C.F.R. 101.9(j)(8)(ii); see also 56 Fed. Reg. at 60377.
[4] See 56 Fed. Reg. at 60377.