Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm381353.htm
Timestamp: 2019-04-22 06:47:50+00:00

Document:
Based on our review, we have determined that GlucoreinTM PCOS is misbranded under section 403(a)(1) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)] because its labeling is false and misleading in that the product is labeled and marketed as a medical food, but it does 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 Title 21 Code of Federal Regulations 101.9(j)(8) [21 C.F.R. 101.9(j)(8)]. Because this product is labeled and marketed as a medical food, but does not meet the statutory and regulatory requirements to be labeled as such, FDA has determined that this product is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. As explained below, introduction or delivery for introduction, of an unapproved new drug into interstate commerce violates the Act. You can find the Act and regulations through links on FDA’s website at http://www.fda.gov.
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 and from foods that make health claims 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, and all foods fed to sick patients are not medical foods. 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 C.F.R. 101.9(j)(8)(ii) and (iii), 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 and a medical food must provide nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition.
Your website at http://nvnth.com and product label promotes the GlucoreinTM PCOS product for the “management of a common female disorder, Polycystic Ovary Syndrome.” GlucoreinTM PCOS “contains two naturally occurring organic substances that have been scientifically proven to address both insulin resistance and hyperinsulinemia: Chlorogenic Acid and L-Cysteine.” However, there are no distinctive nutritional requirements or unique nutrient needs for individuals with PCOS. In addition, although there are benefits to these patients obtaining Chlorogenic Acid and L-Cysteine in their diet, there are no established distinctive nutritional requirements or inherent needs for patients with PCOS to have these substances in their diets.
Thus, this product is not a “medical food” under 21 U.S.C. § 360ee(b)(3) or 21 CFR 101.9(j)(8)(ii). Therefore, the product is misbranded within the meaning of section 403(a)(1) of the Act because the product labeling is false and misleading in that the product is labeled and promoted as a medical food, but it does not meet the definition of a medical food.
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)(1) of the Act [21 U.S.C. §321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as discussed in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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 product is offered for a condition that is 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 this drug safely for its intended purposes. Thus, this drug is misbranded within the meaning of section 502(f)(1) of the Act, in that its labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. 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 violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. 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 your firm complies with all the requirements of federal law and FDA regulations.
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as complies of related documentation. 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 correction.
Please submit your response to Ms. Katrina L. Dobbs, Compliance Officer, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement (HFS-608), 5100 Paint Branch Pkwy, College Park, MD 20740. If you have any questions about this letter, please contact Ms. Dobbs at (240) 402-5163.
 Enteral feeding by tube refers to a tube or catheter that delivers nutrients beyond the oral cavity directly into the stomach or small intestine. It should not be confused with parenteral (or intravenous) nutrient formulations which are regulated by FDA as drugs.
 See Food Labeling; Reference Daily Intakes and Daily Reference Values; Mandatory Status of Nutrition Labeling and Nutrition Content Revision Proposed Rule (56 FR 60366 at 60377, Nov. 27, 1991).
 56 FR 60366 at 60377.

References: § 343
 § 360
 § 321

v. 
 § 360
 §321
 § 355
 § 331
 § 352
 § 331