WARNING LETTER
Terra Biological LLC MARCS-CMS 520430 —
- Recipient:
-
Recipient NameAlan Cash
- Terra Biological LLC
5033 Seachase Street
San Diego, CA 92130
United States
- Issuing Office:
- Center for Food Safety and Applied Nutrition
United States
5001 Campus Drive | |
JUL 18, 2017
OVERNIGHT DELIVERY
SIGNATURE REQUIRED
Alan Cash, Founder and Chief Science Officer
Terra Biological LLC
5033 Seachase Street
San Diego, California 92130
WARNING LETTER
Dear Mr. Cash
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.cronaxal.com in April 2017, and has determined that you take orders there for the product CRONaxal (Oxaloacetate). The claims on your website establish that the product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product 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 Drug
Examples of some of the website claims that provide evidence that your product is intended for use as a drug include:
On the homepage:
- Oxaloacetate supplementation reduces Glutamate levels in the brain in multiple laboratory animals. Glutamate overproduction is directly tied to the growth of malignant gliomas…
- CRONaxal…used with chemotherapy for the clinical dietary management of the metabolic imbalances associated with glial tumors.
On the “About Medical Foods” page:
- CRONaxal…for clinical dietary management of the metabolic needs of Glial tumor patients.
Your product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a “new drug” 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.
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 product CRONaxal (Oxaloacetate) is 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 product safely for its intended purposes. Accordingly, CRONaxal (Oxaloacetate) 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)].
Misbranded Food
Further, even if your CRONaxal (Oxaloacetate) product was not an unapproved new drug, it would still be misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C § 343(a)(1)] because the product labeling is false and misleading in that the product is labeled and marketed as a medical food but does not meet the definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the criteria set forth in Title 21 Code of Federal Regulations section 101.9(j)(8) [21 C.F.R. 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 of food. Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, and must be intended to be used under medical supervision. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms, or reduce the risk, of a disease or condition. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition’s specific dietary management.
Pursuant to 21 CFR 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. Your CRONaxal (Oxaloacetate) product is promoted as a medical food for the dietary management for Glial Tumors, Gliobastoma Multiforme (GBM) and Astrocytoma.
FDA is not aware of any distinctive nutritional requirements for individuals with Glial Tumors, Gliobastoma Multiforme (GBM) and Astrocytoma.[1]CRONaxal (Oxaloacetate) product does not meet the definition of a medical food in the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)] or the regulatory criteria for medical foods set forth in 21 CFR 101.9(j)(8)(ii). Therefore, your
This letter is not intended to be an all-inclusive list of the violations that may exist in at your facility or in connection with your products. It is your responsibility to ensure the products you manufacture and distribute are in compliance with all requirements of the Act and applicable FDA regulations. You should take prompt action to correct the violations cited in this letter.
We request that you notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific steps you have taken to correct the noted violations. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
You should direct your written reply to Anam Drumheller, 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 regarding this letter, you may contact Ms. Drumheller via email at anam.drumheller@fda.hhs.gov.
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
[1] We note that, although oxaloacetate may confer some benefit to certain individuals with glial tumors, the provision of oxaloacetate is not based on any nutritional need. Further, the efficacy of dietary therapies in the management of glial tumors is unknown given the limited human clinical data