FSMA and Third-Party Auditing

A key piece of the regulatory jigsaw puzzle as FDA moves ahead with implementing the Food Safety Modernization Act (FSMA) is the voluntary, user-fee based program for the accreditation of third-party certification bodies to conduct food safety audits of foreign food facilities and issue food and facility certifications.

When this program is up and running, U.S. importers will be able to use the certifications of foreign entities to secure expedited entry of shipments under the Voluntary Qualified Importer Program (VQIP).

The final rule on Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications, published in the Federal Register on November 27, 2015, went into effect on January 26, 2016. However, the agency says it will implement the program after it releases separate Model Accreditation Standards guidance and a final user fee rule.

In July 2015, the agency issued Model Accreditation Standards draft guidance containing draft recommendations on the education and experience needed by third-party auditors and their agents. In the same month, the agency issued a separate proposed rule establishing user fees for accreditation bodies and certification bodies.

FDA does not generally plan to directly accredit third-party certification bodies. Instead, it will recognize accreditation bodies to perform that task. An accreditation body could be a foreign government agency or a private third party. The accreditation bodies will have to monitor the performance of the third-party auditors and submit reports to FDA. They must also maintain records and provide FDA access to the records.

Third-party auditors accredited under the program must conduct unannounced facility audits and notify FDA of any serious public health risk and must ensure that their agents are competent and objective.

The voluntary program allows for two kinds of audits – regulatory and consultative. Only a regulatory audit can be used for certification. A consultative audit is for internal use.

For regulatory audits, the auditor must submit an audit report to the FDA within 45 days. No report is required for a consultative audit, but any potential serious risk to public health identified in a consultative audit must be reported to FDA. All reports and notifications required to be submitted to the FDA must be submitted in English, the rule says.

FDA may grant recognition for an accreditation body of up to five years. Four years is the maximum accreditation period for certification bodies.

With many competing demands from other high-profile FSMA regulations and now with the real possibility of reduced funding in fiscal year 2017 and beyond, FDA may find itself in triage mode in terms of the speed of implementation of the various FSMA rules. But this program could play a significant future role in improving the international oversight of food safety.

What Are Medical Foods (and What They are Not)

Prior to 1972 medical foods were regulated as prescription drugs under section 201(g)(1)(B) of the FD&C Act, requiring manufacturers to conduct drug trials and submit Investigational New Drug license applications and New Drug Applications. It was extremely difficult to innovate new dietary products for medical use because of these time-consuming and cost-restrictive measures. In an effort to foster innovation and ensure reasonable cost and availability of such foods to those needing them, Congress passed the Orphan Drug Act, (21 U.S.C. 360ee (b)(3)), and FDA published its implementing regulations and guidances. FDA differentiated medical foods, which were part of the larger categories of special dietary use foods and dietary supplements, from the even larger broad category of general or conventional use foods. Medical foods would not have to undergo premarket review or approval, thus enabling manufacturers to innovate and develop medical foods according to the latest scientific research in a timely and cost-controlled fashion.

A medical food according to the Orphan Drug Act and clarified by regulation can be found in FDA’s regulations at 21 CFR 101.9(j)(8). A food is a medical food only if:

  1. 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 by tube.
  2. 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;
  3. 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;
  4. It is intended to be used under medical supervision; and
  5. 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.

Medical foods differ from foods for special dietary use and general use foods that can make health claims by the requirement that medical foods are intended to meet distinctive nutritional requirements of a disease or condition, are used under medical supervision, and are intended for the specific dietary management of a disease or condition. Further, FDA in its updated Draft Guidance for industry on medical foods considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category. The guidance gives as example of medical foods, “inborn errors of metabolism” (IEMs) such as phenylketonuria (PKU). In this example, inherited biochemical disorders in which absence of an enzyme interferes with the metabolism of protein, fats, or carbohydrates would be treatable with medical foods. For these IEMs, a medical food is required in addition to a specific dietary modification (e.g., reduced total protein/phenylalanine for PKU) in order to obtain adequate levels of essential nutrients.

The guidance also excludes from medical foods products dealing with diseases resulting from essential nutrient deficiencies like scurvy and pellagra, and does not consider foods designed for the dietary management of diabetes or pregnancy to be medical foods because 1) diabetes can be managed with modification of the normal diet alone, and 2) pregnancy is not a disease. The FDA might consider, however, a medical food to fit legal criteria if it is to be used with a specific disease or condition associated with pregnancy and for which there are distinctive nutritional requirements that cannot be met by the normal diet alone. Conventional foods that do not ordinarily contain protein or are ordinarily low in protein (such as what might be used in the PKU dietary plan) would also not meet the regulatory criteria for medical foods.

It is important to appreciate that 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 not all foods fed to sick patients are medical foods. Further, FDA does not interpret either the Orphan Drug Act or FDA’s regulations at 21 CFR 101.9(j)(8) to require that medical foods be made available by prescription. Medical foods may not bear on labels the symbol “Rx only,” and are not prohibited from being dispensed without a prescription. Medical food should also not have National Drug Code numbers on labeling.

Medical foods are exempt from the labeling requirements for mandatory nutrition labeling, health claims and nutrient content claims under the Nutrition Labeling and Education Act of 1990 (21 U.S.C. 343(q)(5)(A)(iv)). As foods, however, they must comply with all applicable FDA requirements for foods, including the Current Good Manufacturing Practice regulations (21 CFR part 110), Registration of Food Facilities regulations (21 CFR part 1 Subpart H) and, if applicable, regulations specific to the product formulation and processing, such as the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulations (21 CFR part 113), Acidified Foods regulations (21 CFR part 114) and Emergency Permit Control regulations (21 CFR part 108). FALCPA’s allergen labeling requirements apply to all packaged foods including medical foods. Further, an ingredient that is added to a medical food must be safe and suitable and comply with all applicable provisions of the FD&C Act and FDA’s regulations. Any ingredient added to a medical food should be 1) a food additive used in accordance with FDA’s food additive regulations (see 21 CFR 172); 2) a color additive used in accordance with the color additive regulations (see 21 CFR 73 and 74); 3) a substance that is generally recognized, by qualified experts, to be safe under the conditions of its intended use (Generally Recognized As Safe, GRAS) (see 21 CFR 170.30 and 21 U.S.C. 321(s)); or 4) a substance that is authorized by a prior sanction issued by FDA (see 21 CFR 170.3(l)).

Medical foods for infants that are to be used as a sole source of nutrition are called exempt formulas and are subject to their own requirements.

Because the FDA does not approve medical foods before marketing, the first time a manufacturer may hear from the FDA could be in the form of a warning letter. And because some manufacturers would appear to use loopholes in the medical foods regulation to develop and market products with disease indication claims that would not be allowed if marketed as conventional foods or dietary supplements, FDA has indeed issued such letters, citing, among other issues, that the manufacturer has failed to substantiate the disease and its distinctive dietary or nutritional requirements for which its products are intended [21 CFR 101.9(j)(8)(ii)]. The FDA’s conclusion is that the product is not a medical food but is by default, an unapproved new drug because of its claims and thus is misbranded.

More and more companies appear to be entering the medical foods area, but they are finding, even global companies, that medical food regulations may not be as clear cut and understood as thought or hoped for. It is important to understand the intent of the FDA as well as its regulations – in particular where medical foods differ from other categories of foods, and how medical foods can be marketed and labeled so that they would not be misbranded and require reclassification and relabeling, maybe even penalties and market withdrawals or recalls.