New Rules, Greater Protections

March 28, 2008



Through the current good manufacturing practices( CGMPs), FDA requires that dietary supplement manufacturers implement production and process controls in all operations to ensure the quality of their products. However, these new practices do not provide specific information on exactly what controls should be implemented in every operation.

The flexibility built into the CGMPs affords industry members several opportunities. For example, the CGMPs provide manufacturers with the freedom to structure their processes in a manner that is most practical and cost-effective for them. The new rules also empower members to distinguish themselves as responsible manufacturers by setting their own stringent, but workable standards. No matter how the CGMPs are interpreted or implemented, any plan for effective compliance must consider the liability risks that confront every dietary supplement manufacturer.

TESTING

The first question any dietary supplement manufacturer critic will ask-whether that critic is an FDA inspector, consumer, or attorney-is, “What did you know?” The most effective response to this inquiry must include information about what steps you took to comply with new testing requirements.

For example, the CGMPs require testing of final product by batch. However, they do not require any specific number of tests. And, while they require that the testing be based on “sound statistical sampling,” that term is undefined. Whether in reliance on company experts or outside consultants, the burden is on the manufacturer to justify its quality assurance methodology and testing.

Though no testing is required of a company that receives bulk pills for sale under its own label, the company must have formal written procedures for verifying what it has received. This can be accomplished by relying on certificates of analysis, other documentation, or even simple observation. However, relying on verifications or the paperwork of others will not provide meaningful protection from liability, particularly if the product turns out to be misrepresented or adulterated.

You will need to know your products. If implemented effectively, the CGMPs should help prepare you to describe what you knew about them before they entered the market. Your ability to do so could save your business.

QUALITY CONTROL

Critics also will inquire about your manufacturing processes and ask, “What did you do?”

Under the CGMPs, QC regulates manufacturing, packaging, labeling, and even holding operations to ensure that your supplements are sold consistent with your manufacturing records. However, QC need not formulate or establish the processes. Instead, the QC function is a review and approval function.

For example, QC is required to intervene and conduct a material review if any product deviates from specifications, or even if improper calibration alerts you to the potential that a batch may not meet specs. QC must also intervene if a batch deviates from the master manufacturing record or any product adulteration is discovered. QC also includes documenting a decision or finding following a material review.

There is no rule requiring a separate QC department. In fact, under the CGMPs, QC persons need not exclusively perform QC functions. However, an employee’s non-QC functions cannot overlap with his or her QC functions to the point where an employee is reviewing and approving the quality of his or her own work.

Understanding this QC function will empower you to explain and demonstrate “what you did” in a manner that may fend off self-interested critics.

PERSONNEL

After establishing the knowledge and conduct of your business, the next question undoubtedly will be, “Who did it?”

The CGMPs require that QC employees be qualified for their positions. However, qualifications may be established through experience, not just education or training. Although certification is not required, it would be wise to establish minimum levels of education, experience, or training for QC personnel, or at least be able to articulate the experience in a manner that justifies the person’s QC position.

QC employees oftentimes are designated in litigation as persons most qualified or knowledgeable to testify on issues critical to the defense of any product liability case, or even some commercial matters as well. Their experience and their work will be the focal point of any criticism you receive. Therefore, it also helps for QC persons to have strong communication skills as well as confidence in themselves and their work. Indeed, their performance on the job and under oath can make the difference between minimizing your liability risk and paying a large fine or damage award.

RECORDKEEPING

No matter how strong your responses to the prior inquiries, the critic will demand that you “prove it.”

Records must be kept for all operations, including personnel qualifications and training, production and process control system specifications, and supplier qualifications and testing of raw materials, to name a few. QC activities, including material review and approval and rejection requirements, also must be documented.

The CGMPs require that all records must be kept for one year after the expiration date of the product or, absent an expiration date, two years after the last of the batch has left your possession. However, statutes of limitations on many civil actions, including product liability claims, range by jurisdiction from one to six years. Therefore, maintenance of records for more than the required minimum would increase your ability to manage your liability risk and, at the same time, empower your lawyers to mount a comprehensive and more effective attack if you get sued years later. This can be accomplished efficiently through digitizing records.

Remember, in any context, no matter who the critic is, if it is not in writing-it did not happen!

CONCLUSION

There is time to comply. Larger companies with more than 500 full-time employees have until June 2008 to comply with the new rules. Companies with fewer than 500 have until June 2009, and those with fewer than 20 employees have until June 2010.

But, make no mistake, the time to act is now. Formulating and implementing your CGMPs today will not only send a strong message to industry and consumers about how you operate your business, it will also empower you to ensure the quality of your products and minimize your liability. There can be no more effective risk-management program.


Thomas A. Delaney is a partner in the Irvine, CA, office of Sedgwick, Detert, Moran & Arnold LLP, and Richard A. Crites is special counsel. For more information, visit the firm's Web site at www.sdma.com. Delaney is also a member of the Consultants Association for the Natural Products Industry (CANI; Clovis, CA). For more information about CANI, visit www.CANI-Consultants.org