A recent flood of negative news about the safety and integrity of nutraceuticals has drawn the attention of politicians, consumers and lawyers, and prompted at least one industry leader to adopt new quality controls. To help mitigate their risks and reassure retailers and the public, nutraceutical manufacturers need to have clear quality assurance (QA) practices in place.
Investigation bruises industry credibility
The recent problems started in early February, when the NY attorney general's office announced that it had tested store-brand herbal supplements sold at GNC, Walgreens, Walmart and Target, and the tests showed most of the products did not contain the ingredients listed on their labels. Some also allegedly contained ingredients, such as soy and wheat, that were not listed on the label.
The attorney general subpoenaed the retailers for evidence proving their product claims and threatened legal action; in response, the four pulled the supplements from their NY stores. The attorney general's office also requested ingredient and quality control information from four product manufacturers.
Industry trade groups countered that the investigation was politically motivated and based on flawed science: The supplements were tested via DNA barcode testing, which isn't appropriate for the herbal extracts many of the products contained, because the extraction process destroys DNA. After nutraceutical groups pointed out this problem and asked to see the details of the report, the attorney general's office refused to release it.
Flawed or not, the investigation triggered a firestorm of bad publicity for the accused retailers and the industry in general. GNC had its supplements and manufacturing processes independently evaluated and confirmed as safe and compliant, but that wasn't enough. In late March, GNC announced that it had reached an agreement with the attorney general and would expand its testing and supply chain traceability processes, including using DNA barcode testing before extraction. The company also agreed to provide semiannual reports to the attorney general's office. (So far the other three retailers have not announced any similar agreements.)
States ask Congress to increase FDA oversight
GNC's action did not put the matter to rest. In April, attorneys general from 14 states asked Congress to investigate the supplements industry and consider a stronger oversight role for the FDA, which currently is authorized to take action against unsafe products only after they reach the market.
The attorneys general want Congress to look into the adequacy and effectiveness of existing processes for verifying the source, identity, purity, potency and quality of ingredients, as well as the identity, composition, purity, potency and quality of finished products. They also want congressional leaders to consider directing the FDA to develop enhanced manufacturing and supply-chain management requirements, as well as uniform, industrywide QA and verification processes.
Under the existing rules, manufacturers are responsible for following FDA good manufacturing practices (GMPs) and making safe nutraceuticals, but they don't need FDA approval before they can sell a product, and they don't have to register products with the agency. Manufacturers are required to notify the FDA before they start selling a product that contains a "new dietary ingredient," which is an ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994; they also have to submit evidence of the new ingredient's safety.
The industry may add its own standards
It's too soon to tell whether Congress will take any action to increase the FDA's oversight. However, the recent events may spur the nutraceutical industry to create its own additional QA standards, in order to take the lead on consumer safety.
In mid-May, the NY attorney general's office and the Natural Products Association, the industry's largest nonprofit trade group, agreed to work together to ensure the safety and authenticity of herbal products, including supporting the use of DNA barcode testing before an ingredient's extraction. The two also said they plan to work with major manufacturers and retailers to promote a model for product safety, authenticity and transparency. (The industry's general position on regulation has been that the existing FDA oversight is sufficient, although the FDA should do more to get rid of companies that ignore safe practices.)
Quality controls are crucial
In addition to generating damaging headlines, the NY investigation has led to numerous class action lawsuits. Anxious to guard against similar lawsuits and reassure consumers, nutraceutical retailers are likely to want proof that their suppliers have strong quality controls. More than ever, supplement manufacturers will need to be able to demonstrate that they have stringent QA processes in place.
Well-documented processes will help manufacturers show that they are meeting regulatory requirements. The FDA doesn't have the same kind of clearly defined "bright-line" rules for nutraceuticals that it has for pharmaceuticals or medical devices, so compliance can be a gray area. This vagueness makes the rules dangerously open to subjective interpretation by companies, FDA inspectors and auditors.
Nutraceutical companies can leverage their ERP system to help address these gray areas from a regulatory and risk mitigation standpoint. The key is having systems in place to track quality events such as out-of-specification reports, deviations, non-conformances, corrective actions and complaints.
These ERP capabilities help manufacturers put preventive systems in place to capture things like irregularities in raw materials and vendor or production issues. Leveraged properly, these reportable systems can significantly help a nutraceutical company maintain adequate internal controls. If there is a reportable event, and the FDA steps in to do an audit, the ERP quality systems will provide the company with concrete answers and data to support their actions.
Documenting everything that happens in the manufacturing environment and staying on top of any resulting actions is an ongoing challenge, so nutraceutical makers also need an integrated means of handling quality events, which can generate changes in other areas. A business may record a deviation that leads to a corrective action, for example, and the corrective action may reveal a flawed procedure that also causes a change to a standard operating procedure —launching an associated training and verification task to prove the corrective action/modified process has resolved the issue.
An ERP system can support integrated quality controls and help manufacturers mitigate their risks, prove their regulatory compliance and demonstrate the integrity of their products. As Congress and the nutraceutical industry consider additional oversight, these strong QA processes can also help manufacturers address any new requirements that come their way.
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