Under the Dietary Supplement and Health Education Act of 1994 (DSHEA), FDA was tasked with creating a framework of standards required by law that needed to be accepted and utilized by U.S.-based producers of dietary supplements for human ingestion. Supplements come in all types, from liquids to powders, gels, capsules of various composition and texture, and tablets or other solid dosage forms.
One common misconception is the cGMPs (current good manufacturing practices) are the gold standard for handling, testing, packaging and labeling of these products, but they are actually the minimum acceptable standards for the creation of these consumer items.
FDA has done an admirable job in attempting to educate commerce with its expectations under DSHEA, but has seen repeated shortfalls in the adoption of GMPs across various segments of our industry.
The final rule, “Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements,” was published in the June 25, 2007 edition of the Federal Register. Based on recent feedback from members of the Office of Dietary Supplements (ODS) and FDA, confirmed adherence to regulations is continuously improving, but roughly one-third of the industry continues to fail inspections, requiring mandatory changes to their business operations. Another one-third of the inspections generate voluntary changes to operations to come into compliance, while another one-third demonstrate a good understanding and adoption/implementation of these minimal standards.
Under the theory old habits die hard, it should come as no surprise the vast majority of deficiencies are centered on failure to do basic things. Some of these basics are drafting master batch records, failure to identity-test inbound raw materials, failure to label products, and failure to maintain facilities to reduce contamination or adulteration of finished goods. In some instances, raw materials claim to be one thing, but have been laced with active pharmaceutical ingredients (APIs) and passed off as “natural compounds,” generally of a botanical nature, that purport to yield remarkable benefits for the targeted consumer. This segment of the industry is on the periphery, and needs to be sanctioned and prosecuted to protect the rest of the industry and the consumers from the harm.
Other regulated industries, such as the pharmaceutical industry, have never seen non-compliance at the levels indicated by FDA for those of us engaged in dietary supplement production. Consequently, much work must be done to improve consumer safety, and improve the reputation of the dietary supplement manufacturers that fall under FDA’s oversight. Numerous FDA commissioners have stated the agency has adequate legal authority to intervene, but enforcement has been spotty, and responsible industry has been seeking additional federal funding to bolster investigations and prosecutions from FDA, the Department of Justice and FTC where appropriate.
It is rare industry leads the charge in Washington to improve regulations and seeks focused oversight. Members of responsible industry found at the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), and others are to be commended for their continued emphasis on improving industry-regulatory interface and enforcement.
CRN’s work, for example, in evaluating claims through the National Advertising Division (NAD) of the Better Business Bureau along with FTC, is exemplary and has done much to improve and substantiate product messaging. When CRN took the initiative, in concert with Underwriters Laboratories (UL), to stand up and promote the product registry known as the Online Wellness Library (OWL), it signified its commitment to transparency for the consumer and the regulator. This extraordinary effort is to be commended and supported by the entire industry. The CRN OWL is open to all industry, and registration of the product labels is at no charge to the participants.
The current effort by industry leaders and retailers, with help from the scientists at NPA and the Supplement Safety Compliance Initiative (SSCI), is yet another step making sure that oversight of GMPs by third-party evaluators and certifiers has a baseline compliance and comparability. This effort arose from the dealings of various attorneys general in various states who took issue with product content. The SSCI is patterned after the Global Food Safety Initiative (GFSI), which has achieved wide acceptance because of the need for consistent food-handling standards in a hazard analysis and a critical control points (HAACP)-compliant world.
Seminars for compliance with the provisions of product labeling under GMPs, or product sourcing, production, testing and myriad other concerns, are available from trade groups within the industry. If a company is bewildered by the adoption of cGMPs, it would be worth it to find these training resources, where an ounce of prevention is truly worth a pound of cure.
While dealing with GMPs can appear to be an insurmountable task for smaller entities, a few guiding principles, based on common sense, should be helpful as brands attempt to efficiently adopt these minimal standards:
- If it’s not written in a permanent record, it did not happen. That is why some say GMP also stands for “get more paper.” Relying on hearsay is of no value in tracing a problem through non-existent paperwork.
- A non-compliant material or product cannot be tested into compliance. If it fails for potency or purity, it is best to analyze the root cause of the failure, and adopt and implement a corrective action. This may lead to destruction of the material or product, but that is clearly defensible, if the principle we are following is to keep the consumer safe.
- The GMPs are not just for sourcing and manufacturing, but they also encompass packing, labeling and holding operations for dietary supplements.
- Adoption of standard operating procedures (SOPs), routinely reviewed by staff and adapted to meet changing conditions, is essential to running a good operation.
- Ensure suppliers and partners participate in the effort to bring safe products to the marketplace.
- Don’t forget that an organized process should yield an organized facility in terms of product flow, and hire competent people who undergo recurrent training in new processes and methods to exceed the minimal standards of these GMPs.
Mark A. LeDoux is founder, chairman and chief executive officer of Natural Alternatives International Inc. (NAI) an organization established in 1980 with facilities in the United States and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. LeDoux has been a proud member since 1980 of the Natural Products Association (NPA) based in Washington, currently serving as chairman of its Board of Directors. He is former chairman and current board member of the Council for Responsible Nutrition (CRN) based in Washington and was founding chairman of CRN-International based in Switzerland, serving currently on its board of directors. LeDoux also serves on the Nutrition Industry Association–West board of directors and is a recognized participant of the Codex Alimentarius Commission, the United Nations’ food and dietary supplement standard-setting body under joint supervision of its Food and Agriculture Organization and World Health Organization.