NIE discusses the implications posed by FSMA with industry representatives, and their work to meet the challenges head on.
In 2007, the U.S. Food and Drug Administration (FDA) published a “Final Rule,” establishing FDA regulations, which require current good manufacturing practices (cGMP) for dietary supplements (21 CFR 111). The final rule addresses in particular the identity, purity, strength and composition of dietary supplements, as well as the quality of manufacturing processes and the accurate listing of supplement ingredients. As part of the rule, FDA also requires “100 percent identity testing,” which means manufacturers are required to have lab tests verifying that the ingredients declared on their packaging are present in the amount stated,Do not contain contaminants and meet the aforementioned requirements for purity, strength and composition or apply for an exemption.
Then, what Department of Health and Human Services Secretary Kathleen Sebelius described as the “most significant food safety law of the last 100 years,” the FDA Food Safety Modernization Act (FSMA) was enacted on January 4, 2011. For Duffy MacKay, vice president of scientific and regulatory affairs with the Council for Responsible Nutrition (CRN), this signified a monumental shift in FDA philosophy.
“The Agency has shifted focus from responding to problems once they are identified to preventing problems before they occur. The primary implication of this is that finished product manufacturers are more accountable for their supply chain and suppliers have to be more transparent about where ingredients come from and how they are farmed (if applicable), processed, stored and transported,” he said. “The biggest impact is on raw material suppliers that adhere to food GMPs. These suppliers will now be required to develop a hazard analysis and preventive control program.” Other elements of the law give FDA additional authorities, such as mandatory recall authority, more authority to administratively order food to be detained, increased access to records and a more robust facility registration framework.
The focus of FSMA is safety. As dietary supplements are regulated as a category of food, so FSMA also applies to the safety of dietary supplements. To this end, Congress took careful note to a key element of the Dietary Supplement Health and Education Act (DSHEA), the New Dietary Ingredient (NDI) provision.
Section 113(b) of FSMA mandated that FDA publish a guidance document clarifying when an ingredient in a dietary supplement is new, requiring an NDI notification to FDA, the evidence of safety needed in an NDI notification and the appropriate methods for establishing the identity of an NDI no later than 180 days after enactment of FSMA.
“When drafting FSMA, Congress recognized that finalizing and releasing the NDI Draft Guidance was an important element supporting the safe introduction of New Dietary Ingredients into commerce,” said MacKay. “This Draft Guidance had been in the making for about 17 years, so Congress took the new law (FSMA) as an opportunity to instill an absolute deadline for the release of the NDI Draft Guidance. The law applied a deadline, which the Agency met.”
While NDIs are just one area where the industry is still relatively in the dark, as FDA has made no promise when it can expect to finalize the Draft Guidance, FSMA has changed the landscape of the dietary supplement industry and caused concern over possible hardships that could be placed on an already aggressively regulated industry.
A Global Issue
FSMA sets aggressive mandates for both domestic and foreign inspections. In order to meet these strict mandates, FDA may enter agreements with third parties, such as foreign governments to accept certified third-party inspections, offered MacKay. “All of these details still need to be worked out, but currently there are many unanswered questions about how FDA could meet the expectations of the law with its current resources.”
Along with a resource-strapped FDA, the Foreign Supplier Verification Program requirements could prove unduly burdensome for some companies. Ashish R. Talati, partner and chair of the food and drug practice Amin Talati LLC based in Illinois, offered that “consolidation in the industry will increase as many small companies, especially companies that primarily import raw materials, will not be able to handle the increased paperwork and costs associated with compliance.”
“Globalization is having a significant impact on supplier capabilities and resources. Regulatory bodies across the globe are demanding a broad array of documentation with more detail than previously seen. These demands vary from country to country and will continue to escalate the cost of goods,” added MacKay. “These demands will also eliminate marginally capitalized suppliers and those that don’t adapt to changes in world market and regulatory requirements.”
When asked what she viewed as the primary implications of FSMA, Christine McKiernan, quality control manager with New York-based Fortitech, Inc., noted, “Having a thorough system for qualification and release of incoming materials, in particular from international suppliers. The law requires the same focus on safety and quality for material sources domestically and internationally, which can pose problems for companies that do not have the resources to monitor international suppliers sufficiently.”
As an FS22000 certified company, Fortitech already had a strong focus on food safety and quality. In the fall of 2010, it began the certification process for all five of its manufacturing sites, which was achieved between July and October 2011. Each site created a Food Safety Team in charge of complying with the requirements of the standard, but participation by every department was necessary to achieve this goal, McKiernan explained. In addition to its on-site systems and an extensive HACCP program, Fortitech employs a GMP auditor that performs on-site supplier GMP audits along with internal GMP audits to ensure the company’s standards are being met and that corrective actions, where necessary, are followed through.
“[Since the passing of FSMA], demands from customers have increased for on-site audits of the facility and transparency into our processes, and there have been increased documentation demands to confirm processes are in place to ensure safety throughout the supply chain,” said McKiernan. “To date, these demands have been easily met.”
While CRN’s MacKay expressed that the total impact on the industry will not be clear until FDA has completed drafting all of the rules, guidance and regulations associated with FSMA, he said one area to watch will be the application of re-inspection fees, which could prove to be expensive for companies struggling to comply with GMPs.
When the FSMA was enacted on January 4, 2011, few food importers noticed a potentially devastating landmine buried within the statute. That is subsection 107(a)(1)(A), which is ominously entitled ‘Authority to Collect Fees,’ noted Russell Statman, executive director of Virginia-based Registrar Corp.
“Since their inception, the number of cGMP inspections has increased each year. According to FDA data, 2011 had nearly 20 times more inspections than what was performed in 2008. If FDA conducts a cGMP inspection and records its observations on Form 483 as ‘Official Action Indicated,’ or ‘OAI,’ it could begin assessing the FSMA re-inspection fees almost immediately when it returns to determine Whether its observations have been properly addressed,” said Statman. “These fees would more than likely drive costs up for the manufacturer, and in turn for the consumer of dietary supplements as well.”
The statute also creates a potentially expensive new obligation for importers who were listed as the “U.S. Agent” when the foreign food facility registered with FDA. FSMA requires FDA to “assess and collect fees from . . . The U. S. agent for each foreign facility subject to a re-inspection . . . To cover reinspection- related costs.” For FY 2012, these costs will be billed by FDA at the rate of $325 per hour for activities outside the U.S. and $225 per hour for activities in the U.S., Statman explained. “FDA may charge for all time related to the re-inspection (without limit) including planning, traveling, testing, writing reports and ‘whatever components’ are deemed necessary to satisfy FDA. All that time performed by government employees, but charged to the U.S. agent, could add up to a huge bill.”
This is one area where Registrar Corp, a company that provides registration, U. S. agent and compliance assistance for U.S. and non-U.S. companies in the food and beverage, medical device, drug and cosmetics industries, could prove to unload a burden.
“Professional compliance companies are better positioned than importers to absorb and diffuse the costs of reinspections. For example, Registrar Corp serves as the U.S. agent for more than 5,000 foreign facilities worldwide,” said Statman. “Being a U.S. agent is what we do. We are able to utilize our compliance personnel to assist in audits, reducing the risks and costs of re-inspections. Additionally, we have offices around the world that can help us obtain reimbursement from foreign companies. The risk, spread over thousands of facilities, is manageable for us, whereas it is not for someone who is U.S. agent for just a few companies.”
FDA has announced that the first re-inspection invoices will be rendered to U.S. agents after January 1, 2012.
“These invoices may shock the unwary, who did not know about this obligation or did not act in time to avoid it. This is a land mine that can be avoided, and importers ignore it at their peril,” Statman added.
George Pontiakos, president and CEO of California-based BI Nutraceuticals, said he is proud of the industry’s efforts and what its been able to accomplish in a brief window.
“It is non-trivial to change the culture in a company, let alone the culture of an industry and moving from an entrepreneurial/creative mindset to a standards-based, consistent, responsible, systems ownership focus, in a very short time,” he said.
Yet, with safety at FSMA’s core, adulteration is still a prevalent issue for the industry, and it’s something that Pontiakos sees as a blemish the industry must be proactive in eliminating.
“The continued blatant adulteration of raw materials by a segment of the supply chain who maintains the philosophy that it is the buyers job to police and test, and that it is cheaper to provide a discrepant product that may get rejected than a compliant one,” Pontiakos added. “A philosophy that is greed driven, places the customer and consumer at risk and focuses our industry in the continual cross hairs of those in government who want greater regulation.”
It’s one of the reason he said he views the procurement professional as this industry’s unsung hero who needs to be staunchly supported, and requires a change in this philosophy.
“The procurement professionals in nutrascience are the first and candidly the only line of defense we as an industry have right now in ensuring that specification-compliant, safe and efficacious raw materials enter our delivery chain,” he said. “Yes, specifications, quality audits, research and development are all integral to success, but in the end, it is the buyer who issues the purchase order for delivery.
“Marketing sees an opportunity, R&D specifies a product, procurement sources and quality audits, and rarely are the goals of each internal organization aligned. The continued enchantment of purchase price variance instead of total cost of quality is the singular point of failure that has not been adequately addressed to date,” Pontiakos continued. “All of us have a vested interest in seeing our businesses grow and provide value to the consumer; risking our collective wealth vehicles on adulterated and poorly processed raw materials is simply unacceptable. The ownership of sourcing professionally managed suppliers is everyone’s responsibility. Rejections, line-down conditions, fulfillment issues, recalls and customer service support are all far more costly than the differential in kilogram cost of a correct product.”
Tools for the Trade
Trade associations play a vital role in developing guidelines and tools to help fill gaps in undefined or poorly defined areas of regulation. This activity has a dual function of providing guidance to the industry and helping to establish high standards of practice where currently a standard may be lacking. “This is important for both future industry compliance and protecting consumers,” said CRN’s MacKay.
The SIDI Work Group is a collaboration of three dietary supplement trade associations—the Consumer Healthcare Products Association (CHPA), CRN and the United Natural Products Alliance (UNPA)—and expert volunteer member company representatives, which developed a series of voluntary guidelines to serve as resources for the dietary supplement industry. These guidelines can be accessed at www.sidiworkgroup.com:
• The Standardized Information on Dietary Ingredients (SIDI) Protocol, published in 2007 and revised in 2008, details the type and scope of information, in a standardized format, that an ingredient supplier typically needs to provide to a manufacturer about the ingredient that would be used in a dietary supplement. The standardized format is recommended as a resourceefficient alternative to non-standardized, customer-specific questionnaires that were common in the industry.
• In 2010, the SIDI Work Group published the “Certificate of Analysis for Dietary Supplement Components” voluntary guideline to provide recommendations on how to standardize the content and format of certificates of analysis for dietary supplement components.
• The SIDI Work Group will release in 2012 a voluntary guideline for qualifying dietary supplement components. This guideline outlines the important aspects of supplier qualification and recommends application of risk-management principles in the allocation of resources to the process. According to MacKay, it may help dietary supplement manufacturers build supplier qualification programs that may allow them to rely on suppliers’ certificates of analysis.
On the international front, the IADSA Technical Working Group has developed adverse event reporting and GMP guidelines that have an additional benefit in that they are also provided to regulators in countries where either such regulations don’t yet exist and/or they are under consideration. “Thus, these not only assist with industry compliance but also help to shape future regulation around the world,” said MacKay, adding that CRN and IADSA’s work on nutrient risk assessment is another example of industry guidance shaping policy and regulation.
Reaching the Goal
New Jersey-based OmniActive Health Technologies has eliminated supply chain concerns through the strengths of its fully integrated supply chain from seed to final product by using GAP and GMP standards. Its product technologies were scaled up in facilities, which had full-fledged ISO-9000 and HACCP systems in place from inception, as well as a comprehensive food safety system in place under ISO-22000:2005 standards for all its manufacturing facilities. These have been audited regularly and recertified well before the new guidelines came into place, according to Abhijit Bhattacharya, OmniActive COO. “Hence, we have already set up systems which go the extra mile in maintaining records from seed plantation, to the package of practices used during farming including firm controls on agrochemicals and pesticides to be used in a responsible and sustainable fashion.”
While OmniActive isn’t quaking at increased standards, Bhattacharya expressed hopeful words for those making their way through the process.
“When putting increased safety measures in place, in any industry, it always comes with a great deal of challenges in terms of understanding the different standards prevalent in various parts of the world, and designing/building/commissioning plants with quality systems which fold in the best standards,” he said. “Once this hard work has been completed with due diligence, the ability to meet regulatory standard expectations for most parts of the world is clearly in place. As a whole, the cost, time and energy associated with compliance is an investment in providing high-quality food products. Although challenging, the complete process will further the dietary supplement and functional food industry by safeguarding the consumer.
“The FDA is only interested in allowing those companies whose No. 1 concern is consumer safety to produce products for human consumption,” Bhattacharya added. “As news of these efforts becomes more mainstream and consumer awareness of the FDA’s emphasis on safety increases, the industry continues to gain support.”
Amin Talati LLC, (312) 466-1037
BI Nutraceuticals, (310) 669-2100
CRN, (202) 204-7700 Fortitech, Inc.,(518) 372-5155
OmniActive Health Technologies,(866) 588-3629
Registrar Corp, (757) 224-0177
NIE discusses the implications posed by FSMA with industry representatives, and their work to meet the challenges head on.