Does FDA underestimate the time, resources spent on regulatory compliance?

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The Food and Drug Administration is underestimating the amount of time and resources the supplement industry spends annually complying with government regulations, including current good manufacturing practices (cGMPs). 

“The supplement industry spends up to $1 billion each year complying with federal regulations,” said Dan Fabricant, CEO and President of the Natural Products Association.  “FDA’s record keeping analysis once again fails to fully understand what firms spend in terms of time and resources meeting and exceeding federal laws to ensure their products are safe for consumers and labeled accurately.”     

Such estimates are important, explained Dr Fabricant, because the cost of compliance never gets cheaper, “so if the agency says it shouldn't take that long to do things and the reality is it takes much longer, it paints the industry as recidivist and not doing the basics, but the reality is it isn't that basic.”

Dr Fabricant was responding the agency’s request for comment regarding Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Because FDA can request GMP record-keeping documents during a part 111 inspection, they must estimate the burden to industry for requesting these documents every few years through public notice and comment.  

According to the FDA’s analysis, there are about 1,460 firms covered by this, including manufacturers, packagers, labelers, holders, distributors, and warehousers. Using an estimated annual batch production of 1,408 batches per year per company*, the agency has estimated that the burden of requirements are equivalent to 929,140 hours.

In a press release from the NPA, the association said it also believes the hourly estimates provided by FDA for part 111 record keeping are vastly under-rated. In addition, many companies have moved to electronic record keeping and storage, and FDA’s estimates do not consider all of the costs, storage, system controls, and security burdens on industry for compliance.

The agency’s estimates also do not take into account the requirements for adverse events and serious adverse events related to dietary supplements.

Dr Fabricant told us that there is no real economic analysis. “FDA gives hours, but obviously there’s a dollar equivalent with that,” he said. “We’re going to do an in-depth study to get good data to punch back with.”

“FDA is in facilities and they could gather this data there, ask people how long these things take,” said Dr Fabricant. “We’d like to see details. This is where an industry-agency partnership could really produce estimates and then build from there.

“What does all of this mean for finished product quality and the impact on consumers?”

$1 billion on compliance

Based on estimates and research conducted by NPA, the dietary supplements industry spends between $164 million and $190 million per year on cGMPs, between $143 million and $460 million on labeling (one-time costs of label changes due to FDA’s Nutrition Facts Labeling Final Rule) and between $204 million and $357 million (for labeling or relabeling for the 85,000 estimated dietary supplement product SKUs on the market; and about $1.25 million per year on adverse event reporting.

“The time necessary to write, implement and maintain a document control system is extraordinary”

Larisa Pavlick, VP of global regulatory and compliance at the United Natural Products Alliance (UNPA) agreed that the times indicated in Table 1 of the Federal Registry document may be underestimated. Prior to joining UNPA, Pavlick spent nearly eight years as an investigator at the FDA

“Records and record keeping are essential and serve as the backbone of the cGMPs. They are fundamental to ensure control, reproducibility and consistency of each batch of dietary supplements. Typically, record keeping involves many people within various departments, and potentially, over multiple shifts. It is also likely that one batch will be processed over several days before it reaches a finished product. A comprehensive written record is critical to show the product remained in a state of control,” Pavlick told us.

“Based on the top FDA 483 citations, there is a clear need to train industry on the requirements for developing and maintaining ‘written procedures.’ If you look at the top 10 citations in FY16, two of the top 10 are related to written procedures. Failure to have written procedures related to product complaints ranked number 10, and failure to establish written procedures for QC operations ranked number three.

“FDA’s list in Table 1 of the Federal Registry document does not appear to include the supporting documents that would be required for evaluation of a finished product, which only begins with a master manufacturing record and a batch record. The time necessary to write, implement and maintain a document control system is extraordinary,” she continued.

“I believe the times indicated in Table 1 may be underestimated. I think about it in stages, including the development of the document, the implementation and use of the document and the final step as the verification of completion of the steps within the document.  If you look at the time needed to write and train on a Standard Operating Procedure, this would be one value. The second area to consider is the use of the procedure such as a manufacturing record or a batch record. What is the time needed by the operators to issue the document and the use of the document from raw materials-dispensing through the full manufacturing history to finished product release and storage? The final stage and time necessary is the QC review of the full manufacturing history.

“Another factor to consider are the number of variables in this calculation, including the number of products per facility, the types of operation (tablet, capsule, powder, liquid/tincture or other more complex finished-product matrix), and the types of raw materials utilized per product (vitamin, mineral, botanical, other dietary supplement compounds).

“If you took the 14 documents in the FDA Table 1 and considered the time to write, train, use in manufacturing and to review by QC, this could provide a rough estimate for required procedures. Yet, I think that the manufacturing records would need to part of a second table to be evaluated on a per-product basis, and it would need to consider the broad expanse of product types in our industry.”

 

* According to the FDA, the estimate of 1,408 batches per year is near the midpoint of the number of annual batches reported by firms surveyed

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