viernes, 19 de enero de 2018

HP&M Contributes to Fight Against Food Fraud

HP&M Contributes to Fight Against Food Fraud

Link to FDA Law Blog

Posted: 18 Jan 2018 07:31 PM PST
The Preventative Controls requirement for foods require in part that food manufacturers and processors identify potential hazards and implement controls to guard against such hazards. Among the hazards that must be considered are hazards that may be intentionally introduced for purposes of economic gain (‘‘economically motivated hazards’’). USP recognized the value of developing a classification scheme for fraud-related adulterants that could aid in the identification of economically motivated hazards. The USP Food Ingredient Expert Committee (FIEC) convened an Expert Panel to undertake the task.

A member of the FIEC, Hyman, Phelps & McNamara, P.C.’s Diane McColl served on the Expert Panel and participated in the development of a scheme to classify food fraud-related adulterants based on their potential health hazard, and application of the scheme to the adulterants in a database of 2,970 food fraud records.   The classification scheme consists of three broad categories: 1) potentially hazardous adulterants, 2) adulterants that are unlikely to be hazardous, and 3) unclassifiable adulterants.  Categories 1) and 2) are broken down into seven subcategories to further define the range of hazard potential for the adulterants.  When applied to the database of economically motivated food adulterants, 45% of the adulterants were found to be potentially hazardous, 46% of the adulterants were found unlikely to be hazardous and 9% of the adulterants were unclassifiable.

Designed to support food fraud mitigation efforts and hazard identification, the classification scheme is just a first step. Experienced risk assessors recognize that further consideration of the specific circumstances of the potential adulteration should be considered, including whether the adulterant is less than food grade, is unstable in the food matrix, may obscure a hazardous defect in the food or may negatively affect the nutritional profile of the finished food.  Additional factors to consider are toxicity, stability and purity of the adulterant as well as dietary exposure to the adulterant.  Detailed discussion of the classification scheme together with examples for each subcategory is available here.

Posted: 18 Jan 2018 05:26 PM PST
On December 29th, the Drug Enforcement Administration (“DEA”) published notice of its intent to temporarily control fentanyl-related substances that are not currently regulated under the Controlled Substances Act (“CSA”).  Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I, 82 Fed. Reg. 61700 (Dec. 29, 2017).  DEA has temporarily scheduled other substances fentanyl-related substances over the past four years, including cyclopropyl fentanyl on January 4, 2018. Schedules of Controlled Substances: Temporary Placement of Cyclopropyl Fentanyl in Schedule I, 83 Fed. Reg. 469 (Jan. 4, 2018).  However, as DEA notes these prior scheduling actions have not proven effective because  when it temporarily schedules a fentanyl-related substance, illicit manufacturers abroad structurally modify the substances and smuggle them into the U.S. and distribute them as non-controlled substances.  Also, the alternative of attempting to prosecute these individuals under the controlled substances analogue statute is difficult. Temporary Placement of Fentanyl-Related Substances, 61701 n.3.  This does not affect the scheduling of already approved fentanyl pharmaceutical products that are FDA-approved and currently regulated/scheduled by DEA.

DEA is now attempting to temporarily schedule fentanyl-related products by defining the class of products in such a manner so as to be broad enough to effectively capture any fentanyl-products being illicitly manufactured. Previously, the agency has had to schedule each substance based on its chemical make-up to ensure it met the legal definition of a controlled substance.  In almost all cases, the CSA controls a drug or substance by its specific formulation.  In this case, DEA is attempting to control a substance based on a definition of its potential formulation.

DEA’s notice states that deaths associated with the abuse of substances structurally related to fentanyl in the U.S. have reached an alarming level. DEA asserts that “chief among the causes is the sharp increase in recent years is the availability of illicitly produced, potent substances structurally related to fentanyl.” Fentanyl is about a hundred times more potent than morphine and the substances subject to temporary control are typically manufactured outside the U.S. by clandestine manufacturers and smuggled into the country and are often mixed with heroin, cocaine and methamphetamine or used in counterfeit pharmaceutical prescription drugs.

None of the affected fentanyl-related substances have an accepted medical use in the U.S. nor are they the subject of an exemption or approval under section 505 of the Food, Drug and Cosmetic Act. Fentanyl-related substances subject to exemption or approval will be excluded from the temporary scheduling order.

DEA’s attempt to create a definition for such substances includes the temporary scheduling of any non-controlled substance not assigned a DEA Controlled Substance Code Number that is structurally related to fentanyl by any one or more of the following specific modifications:

  1. Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;
  2. Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
  3. Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
  4. Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or
  5. Replacement of the N-propionyl group by another acyl group.
As noted above, this is a different approach to scheduling and we will see if these definitions can withstand the expected challenges from defense attorneys related to whether this type of scheduling is consistent with the CSA.

DEA will publish the scheduling order in the Federal Register on or after January 29, 2018 and it will be effective immediately. Temporary scheduling will last for two years, but DEA can extend it for an additional year if proceedings to permanently schedule the substances are pending.

No hay comentarios: