Accera, Inc. 12/26/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
December 26, 2013
VIA OVERNIGHT DELIVERY
Holger Kunze, President and CEO
Interlocken Advanced Technology Park
380 Interlocken Crescent, Suite 780
Broomfield, Colorado 80021
Dear Mr. Kunze:
This is to advise you that the U.S. Food and Drug Administration (FDA) has reviewed the label for your Axona® product and your website at the Internet address http://www.accerapharma.com/ in December 2013. The Axona® product is accompanied by a four-page insert that provides additional product information, including a reference to your website at Internet address http://www.about-axona.com/. Your website at http://www.accerapharma.com/ refers potential customers to http://www.about-axona.com/, which site provides a link from which medical professionals can obtain your Axona® product. Your Axona® product is labeled as a “medical food,” and the claims on your product label and website represent the product as a “medical food intended for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease.”
Based on our review, we have determined that Axona®
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 the labeling is false and misleading in that the product is labeled and marketed as a medical food but 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 section 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 its regulations through links on FDA’s website at http://www.fda.gov
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” [21 U.S.C. § 360ee(b)(3)]. The regulation in 21 C.F.R. 101.9(j)(8) sets forth criteria that a medical food must meet. Specifically, this regulation provides that a food is a medical food only if:
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 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 websites at http://www.accerapharma.com/ and http://www.about-axona.com/, and your product label promote your Axona® product for the “management of the metabolic processes associated with mild to moderate Alzheimer’s disease.” However, there are no distinctive nutritional requirements or unique nutrient needs for individuals with mild to moderate Alzheimer’s disease.
Thus, this product is not a “medical food” under 21 U.S.C. § 360ee(b)(3) or 21 C.F.R. 101.9(j)(8). 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.
Unapproved New Drug
The therapeutic claims on your product label and website establish that your Axona® product is a drug under section 201(g)(1)(B) of the Act because it is intended for use in the cure, mitigation, treatment, or prevention of disease.
As explained further below, introduction or delivery for introduction, into interstate commerce, violates the Act. Examples of some of the claims in your product labeling that provide evidence that your product is intended for use as a drug include:
On your product label:
- “Axona is a medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer’s disease.”
On the website http://www.accerapharma.com/, under the “Products” Tab:
- “Axona may enhance memory and cognition in mild to moderate Alzheimer’s.”
On the website http://www.about-axona.com/:
- “[I]ntended for…metabolic processes associated with mild to moderate Alzheimer’s disease.”
- “Axona . . . provid[es] a unique way to help you care for your loved one with mild to moderate Alzheimer’s disease. Axona is simple to add to existing treatment regimens, or it can be used on its own.”
On the website http://www.about-axona.com/, under the tab “How Axona could help,” under the link “How Axona Works”:
- “[R]aised ketone body levels can enhance memory and cognition in some people with mild to moderate Alzheimer’s disease.”
- “Axona can help during times of diminished cerebral glucose metabolism.”
On the website http://www.about-axona.com, under the “Healthcare Professional Site” tab:
- “[Axona] helps patients with mild to moderate Alzheimer’s disease by addressing diminished cerebral glucose metabolism [DCGM].”
- “[Axona] helps address this deficiency by providing ketones as an alternative fuel source for neurons.”
- “Adding Axona to Alzheimer’s disease management addresses different aspects of the disease at the same time and may further enhance memory and cognition.”
On the website http://www.about-axona.com, under the “Healthcare Professional Site” tab, and the tab “Ketone Bodies,” under the link “Ketone Bodies in Alzheimer’s Disease”:
- “[R]esearch has demonstrated the beneficial effects of raised ketone body levels.”
- “[K]etone bodies an attractive means to address diminished cerebral glucose metabolism in Alzheimer’s disease.”
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 the all requirements of federal law and 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 injunction.
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 copies 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.
Charlotte A. Christin
Office of Compliance
Center for Food Safety
and Applied Nutrition
cc: FDA Denver District
 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.