Implementing FSMA for Imports is FDA’s Biggest Challenge

FDA hosted an excellent day-long public meeting on March 21, 2016 to review the import-related elements of the new FSMA regulations. In opening remarks, FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor noted that implementing import provisions is the agency’s biggest FSMA challenge.

In a March 21 FDA Voice blog, Taylor called the Foreign Supplier Verification Program (FSVP) “the ‘regulatory linchpin’ of FSMA’s historic paradigm‎ shift for imported food from reaction at the border to accountability for prevention at the point of production.”

Section 301 of FSMA requires importers to have a foreign supplier verification program and the Importer of Record must verify that suppliers have adequate preventive controls to assure the safety of their products. It is the importer’s responsibility to determine the hazards and the best way to verify that preventive controls are being implemented.

A preventive control may not be required for some low-risk products. But this does not mean that low-risk products such as candies, cookies or crackers are exempt from FSVP, just that a hazard analysis may show no significant hazard so no special controls are required.

The FDA does not plan to create a list of high-risk products, but the agency may require special preventive controls in some circumstances.

Food exempted from FSVP requirements include juices and seafood covered by existing HACCP rules, food used for research and development, food for personal consumption, and alcoholic beverages and ingredients (when the importer uses them to make alcoholic beverages). Also exempt are foods transshipped through the U.S., foods imported for processing and export, foods originating in the U.S. that is returned, and meat, poultry and egg products regulated by the U.S. Department of Agriculture.

To the surprise of some stakeholders at the March 21 public meeting, foods imported for distribution as samples at trade shows are not exempt from FSVP requirements.

In some circumstances importers may comply with FSVP requirements if they can establish that there is a system in place to control a hazard at a subsequent stage in the distribution chain. If a hazard is controlled by an importer’s customer or other entity in the distribution system, the importer must have documentation in the form of a disclosure statement and written assurances.

The FSVP preventive control requirements are aligned with those of the FSMA preventive controls and produce rules. The goal is to produce food using the same level of public health protection and to assure that the products are not adulterated or misbranded, especially with regard to allergen labeling. Although the FSVP is not a border program, it will require identification of the importer at the point of entry.

In addition to requiring importers to implement FSVP requirements, FDA plans to conduct more foreign inspections and to work more closely with foreign governments. The agency may determine that some countries have equivalent food safety systems, which should benefit suppliers in those countries. But this will be lengthy process and will likely take years to accomplish for each country. New Zealand was the first country FDA designated as having an equivalent system. Currently, Australia, Canada — and most recently the European Commission — are being considered for this designation.

The final FSVP rule was published on Nov. 27, 2105. Because the compliance dates are aligned with those of the separate preventive controls and produce rules, importers will need to comply with whichever is the latest of the following dates:

  • 18 months after the publication of the FSVP final rule;
  • For the importation of food from a supplier that is subject to the preventive controls regulations for human food or animal food or the produce safety regulation, 6 months after the foreign supplier of the food is required to comply with the relevant regulations; or
  • For an importer that is also subject to the supply-chain program provisions in the preventive controls regulations for human food or animal food, the date the importer, as a receiving facility, is required to comply with the supply-chain program provisions of the relevant regulation.

FDA is currently developing guidance that will give more clarity to the FSVP compliance requirements in specific circumstances, such as in the case of suppliers in countries or regions deemed to have equivalent controls. But the agency says importers should not delay in assessing their products and their suppliers with a view to achieving compliance.

The Purpose of a DEA Regulatory Investigation

Everyone has read recent newspaper and internet stories about the rise in heroin abuse and its relationship with pharmaceutical opiates that were originally prescribed for legitimate medical reasons. Unfortunately, this problem has been around since the Civil War when morphine was given to soldiers for horrific injuries, and the soldiers became dependent on that narcotic. Any controlled substance—narcotics, depressants, or stimulants—has the potential for abuse.

It is the responsibility of the U.S. Food and Drug Administration (FDA) to protect the public health by assuring the safety, efficacy and security of human and veterinary drugs, but the U.S. Drug Enforcement Administration (DEA) is responsible for a subgroup of drugs—controlled substances. A controlled substance differs from a regular prescription drug in that controlled substances have the potential for physiological and/or psychological abuse and have been designated as controlled under U.S. law or international treaty.

The DEA is responsible for preventing the diversion of controlled substances and listed chemicals (used to manufacture illicit drugs) from their legitimate medical use to illicit drug trafficking. To prevent the diversion of legitimate controlled substances and listed chemicals, DEA registers and issues individual registration numbers to all businesses that import, export, manufacture or distribute controlled substances; all medical professionals licensed to dispense, administer or prescribe controlled substances; and all pharmacies authorized to fill prescriptions.

When a business or individual is issued a DEA registration, that business or individual is responsible for keeping all controlled substances under their control from being used for illegal purposes. This is accomplished by requiring each DEA registrant to keep certain records and maintain specific security measures to manage their controlled substances. The records allow the registrant to know the kinds and amounts of controlled substances under their supervision at any time. There are different security requirements for specific controlled substances, depending on their potential for abuse.

When DEA investigators conduct a regulatory investigation of a business establishment, their primary purpose is to assure that no controlled substances are being diverted illegally. The investigations are required under federal law and are usually unannounced. The investigators will take an inventory of controlled substances on hand and review records. The investigators will usually audit individual controlled substances using records and documents provided by the business.

During the DEA regulatory investigation, the DEA investigators will attempt to account for every dosage unit of controlled substance at the location during a three-month to one-year period. The investigators accomplish this by reviewing all controlled substance records including records of receipt, sales or dispensing, destruction, theft or loss, and any other record relating to controlled substances.

The investigation will also include a review and testing of the security measures for all controlled substance storage locations at the business. This includes providing the names and personal information of employees having access to controlled substances. The registrant must check the background of all employees with access to controlled substances to ensure they have not been convicted of a drug related felony or used controlled substances illegally.

Depending on the results of the regulatory investigation, the investigators may use the visit to educate the registrant. If deficiencies are found, DEA may issue a Letter of Admonition requiring a written response describing the actions to correct any deficiencies. If more serious deficiencies are noted, the registrant may be subject to a formal administrative hearing or federal civil or criminal charges.

A regulatory investigation is one of the tools DEA uses to ensure that controlled substances are used for legitimate reasons.