FDA Announces FSMA Fees for Fiscal Year 2015

 

FDA announced the Food Safety Modernization Act (FSMA) domestic and foreign facility reinspection, recall and importer reinspection fee rates for Fiscal Year (FY) 2015, in an August 1, 2014 Federal Register notice. Section 107 of FSMA added section 743 to the FD&C Act giving FDA the authority to assess and collect fees from the responsible parties of domestic and U.S. Agents of foreign facilities requiring reinspections; domestic facilities and an importer who do not comply with a recall order and importers subject to reinspections. The FSMA Fee Schedule for FY 2015:

  • Hourly rate if domestic travel is required $217 and
  • Hourly rate if foreign travel is required $305

These fees are effective on October 1, 2014, and will remain in effect through September 30, 2015.

These fees will be assessed for the reinspection to evaluate if a firm has taken the appropriate corrective actions from the prior inspection in where “Official Action Indicated” (OAI) was indicated. The responsible party for each domestic facility and the U.S. agent for the foreign facility will be required to pay the reinspection fees. The fees will be based on the number of hours spent on the reinspection. This will include time to conduct the physical inspection preparation for the reinspection, travel time, report writing, collecting and analyzing samples, etc. to ensure the facility is compliant.

In addition FDA will be assessing fees for non-compliance with a recall order to cover food recalls. Non-compliance may include: not initiating a recall as ordered by FDA and/or not performing the recall in a manner specified by FDA recall order and/or not providing FDA with requested information regarding the recall order. The responsible parties for a domestic facility and an importer who does not comply with the recall will be responsible for paying the assessed fees. These fees will be assessed on the direct number of hours spent on the FDA taking action in response to the firm’s failure to comply with the recall order.

FDA will be invoicing the responsible parties for paying the fees after the Agency has completed the work for which the invoice is based and payment will be required within 90 days in U.S currency by check, bank draft or U.S. postal money order.

Also, FDA is developing guidance documents to outline the new processes for requesting a reduction of fees for the reinspection and recalls and the agency’s process for assessment and collection of fees from importers.

FDA’s reinspection fees for 2015

 

FDA Sends Revised FSVP Rule to OMB

 

The Food and Drug Administration recently sent a revised rule to the White House Office of Management and Budget (OMB) that will be an important tool in FDA’s future oversight of foods and ingredients imported into the United States.

Under FSMA, FDA has increased regulatory authority over imported foods. For example, it can block a food from entry if the facility has refused inspection by U.S. officials. Of course, resource-related constraints prevent FDA inspection of more than a handful of foreign producers annually. Lawmakers recognized these limitations and included other provisions in section 301 to increase oversight of imports.

On July 26, 2013, FDA released proposed Foreign Supplier Verification Program (FSVP) regulations that would require importers to verify that food imported into the United States is produced in a way that “provides the same level of public health protection as is required for domestic food producers.” The revised rule will not be publicly available until OMB completes its review.

However, many proposed elements will certainly be included in the final document. Under the proposed FSVP, importers must have a foreign supplier verification program; they must review the compliance status of the food, and of the potential foreign supplier, before importing the food. These reviews would take into account any FDA warning letters, import alerts, and certification requirements issued by FDA.

Importers would also be required to identify the hazards associated with each food they import. Among other tasks, they would be required to review any complaints they receive about the foods they import, take corrective actions and revise their FSVPs as needed.

As originally proposed, FDA set out two risk-based options for supplier verification activities. Either foreign suppliers will control the hazards, or will verify that the hazards are being controlled by its raw material or ingredient supplier.

Under Option 1, if the foreign supplier controls the hazard at its establishment and there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA), the importer would be required to show documentation of onsite auditing of the foreign supplier. For non-SAHCODHA hazards that the foreign supplier controls, the importer would be required to conduct one of more of the verification activities (onsite auditing, sampling and testing, review of the supplier’s food safety records, or some other appropriate procedure) before using or distributing the food.

Under Option 2, for all hazards that the foreign supplier will either control or verify that its supplier is controlling, importers would need to choose a verification procedure from among onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure.

If the importer’s customer will be controlling a hazard identified by the importer, the importer would need to obtain written assurance, at least annually, that its customer is following procedures (identified in the written assurance) that adequately control the hazard.

The proposed rule also states FDA’s intent is to align the supplier verification provisions in the FSVP regulations with any other supplier verification provisions that may be included in the final rules on preventive controls for human and animal food. This would avoid duplicative requirements for an entity that is both a food importer and a registered food facility.

Under the proposed rule, modified FSVP requirements would apply in certain circumstances, including the following:

  • Importation of a dietary supplement or dietary supplement component;
  • Importation of food by a very small importer or importation of food from a very small foreign supplier; and
  • Importation of food from a foreign supplier in good standing with a food safety system that FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
  • The proposed rule would exempt importation of the following foods from FSVP requirements:
    • Juice and seafood from facilities that are in compliance with the Hazard Analysis & Critical Control Points (HACCP) regulations, which contain their own supplier verification provisions;
    • Food imported for research or evaluation purposes;
    • Food imported for personal consumption;
    • Alcoholic beverages; and
    • Food that is transshipped or imported for further processing and export.

Deciding which food products are high-risk will be an especially difficult part of the implementation of the FSVP. The term “reasonable probability” of exposure to a hazard is imprecise and likely to be contested. Adequate control of hazards will not mean a “high risk” product becomes non-high risk no matter how many safety measures they put in place. The fact that such controls are needed determines the high risk status of a food.

The Impact of Social Media on FDA-Regulated Products

Historically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use of the internet and social media has added increasing complexity to the issue for the agency as well as for FDA-regulated industries.

As a result, the FDA issued several guidance documents this year and, while applicable only to prescription human and animal drugs and medical devices, they should be used to gauge the agency’s current thinking with regard to social media and its use for promoting the products they regulate. The first guidance, issued in January, clarified FDA’s position on what constitutes interactive promotional media and how manufacturers, packers, distributors and those entities acting on their behalf can fulfill their regulatory obligations with regard to such communications. In June, the agency issued two further guidances; one detailing how firms should go about correcting misinformation that is disseminated through a third party and another addressing how risk and benefit information should be presented for those social media platforms with character space limitations, e.g., Twitter. It is clear that this subject is being given considerable attention at the FDA.

These guidances stress that firms are responsible for promotional communications and other content on internet-based platforms that they own, control, create, influence, or that are operated by, or on behalf of themselves (or any employee or agent working for them.) For content posted on third party platforms, a firm may also be responsible if it has any control over or influence on that platform. The FDA recommends that firms clearly disclose their involvement with any platform for which they own or influence the content.

However, the internet and associated technologies have made it easier for those not affiliated with these firms to disseminate product information. This user-generated content (UGC) created by third party entities may be incorrect or incomplete, thus potentially endangering public health either by understating safety information or inflating the benefits of a particular product.

The FDA’s position is that firms are “generally not responsible” for third party UGC as long as they are truly independent of its source. However, if a firm voluntarily chooses to correct misinformation of which they become aware, the FDA has set forth specific recommendations as to how this should be accomplished and recommended that records be maintained accordingly.

While these guidance documents are applicable only to prescription drugs and medical devices, it is reasonable to expect that the FDA believes these same principles apply to OTC drugs, dietary supplements, foods and cosmetics. For such products, the FDA regulates the content of the labeling and the Federal Trade Commission is responsible for regulations regarding advertising. However, on social media platforms the information may be presented in such a way that it could be considered both labeling and advertising. For example, a website or Facebook page may include product usage details and claims, as well as a link to purchase the product or “Share” or “Like” it to another site.

Indeed, a recent FDA warning letter issued to Zarbee’s Inc., a dietary supplement company, dealt with just this issue. While other companies have received warning letters for making false or misleading claims on their websites, in this instance the agency also cited Zarbee’s for personal testimonials that had been posted and subsequently “Liked” on their Facebook page. These “Likes” were considered equivalent to an endorsement or promotion of Zarbee’s products that were, as formulated and labeled, considered “new drugs” and hence subject to FDA oversight.

In all cases, firms must ensure that any communication for which they have control or oversight is truthful, not misleading and substantiated. Although they may not be held responsible for content generated by third parties, they should be careful not use such information or endorsements in their own advertising and promotions. In addition, firms should consider correcting any misinformation of which they become aware, particularly if it is a safety issue.

Social media is a powerful tool and fast-evolving information platform. There is no doubt that the FDA, FTC and other regulatory bodies worldwide will further define and clarify their approaches to monitoring and regulating advertising and promotion of products this way. It would therefore be wise for industry to become familiar with current agency expectations and stay abreast of future developments. In addition, companies should have their websites and social media sites reviewed for compliance with FDA regulations to ensure that all of the content is truthful, substantiated, permissible and not misleading.

Follow-Up to the July Issue of the Month

Our July Issue of the Month article titled “Why Submit a GRAS Notification for a Dietary Ingredient?” drew a lot of attention from readers. In this follow-up note, Jim Hoadley responds to one significant question.

Is an NDI exempt from the NDI notification requirement when the same substance is the subject of a food ingredient GRAS determination, but the ingredient has not been marketed as a conventional food ingredient?

Good question – I’m glad you brought it up because the newsletter article was not as clear as it could have been on this point. The NDI notification requirement exemption is for “ingredients which have been present in the food supply as an article used for food…” Submitting a GRAS notification does not exempt a dietary ingredient from the NDI notification requirement – the GRAS determination is only the first step and it must be followed by actually getting this ingredient into the food supply through marketing it as a food ingredient. Submitting the GRAS notification to FDA is voluntary; however, when your use of a new ingredient as a GRAS food ingredient serves as an alternative to a NDI notification then it is wise to submit the GRAS notification as documentation of your conclusion that the consumption of the ingredient will be safe. In this sense the FDA’s GRAS Notification Program serves as a substitute to an NDI notification. GRAS self-determination as a food ingredient is not a path to be used to avoid submitting a safety notification for your NDI.

When you have submitted a GRAS notification for a food ingredient use; but, have not yet actually marketed the ingredient for the food use then the ingredient is NOT present in the food supply. The exemption from the NDI notification requirement kicks in only when the ingredient is present in the food supply.

When the marketing of a substance as a GRAS food ingredient is being used as a substitute for submitting an NDI Notification there are a couple points to keep in mind. Firstly, ingredients specified in the GRAS Notification and the NDI must be in the same chemical form without alteration. Secondly, the NDI consumption resulting from its dietary supplement use should be the same as, or lower than, the intake level that has been determined to GRAS.