Medical Foods Q&A Update – Is FDA Preparing for Action? Is Pregnancy a Disease? What’s Next?

Yesterday, the FDA released an update to its 2007 Questions and Answers document on Medical Foods.  Interestingly, it is the new information in this document that has us scratching our heads about the implications of this revised draft document. 

The Medical Food category has always been a somewhat of an enigma.  In some instances, manufacturers of these products have tried to hide behind the somewhat lax regulatory criteria for Medical Foods and, in some cases, have tried to make arguments that products like prescription prenatal vitamins should be placed into this category (see more below).  The new draft guidance really nixes that argument by indicating that the use of “Rx only” designation on a medical food actually would make that product misbranded.  The Agency states this in its response to Question 13 – “May the labeling of a medical food bear the symbol Rx Only?”:

The labeling of medical foods may not bear the symbol “Rx only.”  Section 503(b)(4)(A) of the FD&C Act (21 U.S.C. 353(b)(4)(A)) provides that a prescription drug is misbranded if the label of the drug fails to bear, at a minimum, the symbol “Rx only””  Section 503(b)(4)(B) of the FD&C Act further provides that a drug that is not a prescription drug is misbranded if the label of the drug bears the symbol “Rx only”.  The requirements about the symbol “Rx only” were added to the FD&C Act by Section 126 of the Food and Drug Administration Modernization Act of 1997 (FDAMA).  Prior to the enactment of FDAMA, Section 503(b)(4) of the FD&C Act provided that a prescription drug was misbranded unless its label bore the statement “Caution:  Federal law prohibits dispensing without prescription.”  FDAMA amended section 503(b)(4) of the FD&C Act to remove the requirement for this caution statement and instead to require the “Rx only” symbol.

The requirement that the labeling of prescription drugs bear the symbol “Rx only” replaced the requirement that the labeling of prescription drugs bear the statement “Caution: Federal law prohibits dispensing without prescription.”  Section 126 of FDAMA made no substantive changes to section 503(b)(4) of the FD&C Act other than to replace the longer caution statement with the symbol “Rx only”.  FDA concludes that, in making this amendment to Section 503(b)(4) of the FD&C Act, Congress intended for the symbol “Rx only” to communicate the same message to consumers that the longer caution statement communicated — specifically, that federal law prohibited a prescription drug product from being dispensed without a prescription.  Therefore, the symbol “Rx only” is not to be used in the labeling of products that are not prohibited by federal law from being dispensed without a prescription.

Medical foods are not prohibited by federal law from being dispensed without a prescription.  Therefore, the use of the symbol “Rx only” in the labeling of a medical food would misbrand a medical food under section 403(a)(1) of the FD&C Act because it would be a false statement about that product.  However, because medical foods are required by statute to be formulated to be consumed or administered enterally under the supervision of a physician, FDA would not object to the use of language to communicate this requirement in the labeling of a medical food product that is otherwise not false or misleading (e.g., “must be used under the supervision of a physician”).

In addition, the Agency document specifically states that, although one of the requirements applied to medical foods is that they must be consumed or administered under the supervision of a physician, that no prescription is required for obtaining the products.  The requirement for a written or oral prescription in Section 503(b) of the FD&C Act and its implementing regulations at 21 CFR 201.100 only applies to the dispensing of prescription drug products.  This also argues against the possibility that prescription prenatal vitamins, a product that has long lived in regulatory never-never land could be a medical food.  For that matter, since the same prohibition of the use of the Rx only symbol and the requirement for a verbal or written prescription are also NOT permitted on a dietary supplement, this cements their place in the “where in the regulatory framework would such a product fit?” category!

Another new question addressed by the Agency’s document is [S]hould National Drug Code Numbers (NDC) be used on medical foods?  The Agency response is a resounding No!

The labeling of medical foods should not include National Drug Code (NDC) numbers.  Drug products are identified and reported using a unique, three-segment number, called the NDC, which is a universal product identifier for human drugs.  NDC numbers are intended for uniquely identifying drugs and should not be used in the labeling of medical foods.  The presence of an NDC number on a product that is not a drug may be a false or misleading representation that misbrands the product under section 403(a)(1) of the FD&C Act.  In addition, FDA considers any representation that creates an impression of official FDA approval through the use of an NDC number in labeling to be misleading.

The new document addresses the issue of products associated with the treatment of inborn errors of metabolism (IEM) and gives examples of types of IEMs that are treated with medical foods.

The Q&As further appear to foreclose the inclusion of prescription prenatal vitamins in the medical food category.  FDA states that it does not consider pregnancy to be a disease, and while acknowledging that there may be special nutritional requirements for pregnant women, they believe that these requirements can be met by diet alone and concludes “[T]herefore, FDA generally would not consider a product labeled and marketed for pregnancy (rather than a specific disease or condition associated with pregnancy) to meet the regulatory criteria for a medical food”.

FDA also indicates that it does not consider products for Type 1 and Type 2 Diabetes Mellitus (DM) to be considered medical foods as the mainstay of managing DM is diet.

The full 25 Questions and Answers (as compared to the 9-question 2007 document) can be found here. This revised Q&A document, albeit in draft, gives the public a look into the FDA’s thinking relative to medical foods.  It also answers some questions about their thinking on categories of products whose regulatory status has remained fairly elusive over the years.  Could this mean that the Agency is beginning to take aim at those products?  We may need to wait for the guidance to become final and we will certainly be interested in the comments this document will likely generate from industry.

If you have any questions relative to medical foods or dietary supplements, please contact Joan Janulis at j.janulis@lachmanconsultants.com