The Dietary Supplements Regulatory Summit took place in Washington DC at the Willard InterContinental Hotel. The event was led by the main US trade associations representing the vitamins and dietary supplement (VDS) industry including the Council for Responsible Nutrition (CRN), the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Natural Products Association (NPA) and the United Natural Products Alliance (UNPA). The summit provided regulatory updates from the FDA and industry professionals. Below is a summary of the highlights from the event.
Source: Dietary Supplements Regulatory Summit
Significant growth in the number of VDS manufacturers is a challenge for the FDA
Cara Welch, senior advisor for the FDA Office of Dietary Supplements Programs, highlighted that when the Dietary Supplement Health and Education Act of 1994 (DSHEA) was created, the US had only 600 VDS manufacturers, but today this number has reached over 12,500 manufacturers, with 9,300 registered with the FDA. In terms of number of products, in 1994 she estimated 3,400 separate SKUs on the market versus more than 60,000 VDS products today.
The above means that the FDA has gathered over 20 years of VDS data from new dietary ingredients (NDI) notifications, claim notifications and inspectional data and is currently trying to better analyze that data to optimize its impact. More importantly, however, this data also means that the FDA has an increasing amount of work which they have to manage with only 26 full time employees.
FDA nutrition and supplements facts final rule got extended for another 18 months
On May 5, 2018, the FDA announced that it will extend the compliance for new label requirements around nutrition and supplements facts by approximately one and a half years. This means that VDS firms will have more time to adapt to these rules by including nutritional information on dietary supplements labels. The final rules were last published May 27, 2016 and the FDA expects that this extension will be sufficient for firms to complete and print updated Nutrition Facts labels.
Summary of new label requirements
Source: www.fda.gov
The industry agrees that the new fibre definition should be removed
On May 2016, the new FDA nutrition and supplement facts label final rule included a section with a new definition for the term “dietary fiber”. This new definition requires that isolated or synthetic non-digestible carbohydrates provide a beneficial physiological effect to be considered dietary fibre. The FDA listed some fibre sources but many types of fibres currently used in VDS, such as inulin, were not listed and this is a concern for the VDS associations.
Jay Sirois, senior director, regulatory and scientific affairs at CHPA emphasized the fact that the AHPA, CRN & NPA all provided similar dietary fibre feedback. The AHPA proposed that the new definition of dietary fibre should be reviewed and revised to allow ingredients recognized by international health authorities such as isolated or synthetic non-digestible carbohydrates. These ingredients are allowed by the European Food Safety Authority (EFSA) and have authorized health claims.
The CRN suggested to withdraw the new definition upon further consideration of submitted comments, and the NPA went even further and suggested to remove it because it means that many VDS which now include fibre claims would not be able to make such claims any longer.
Best Practices for FDA inspection
Brenda Van Goethem, director of regulatory affairs at Nature’s Way, highlighted how VDS firms can prepare for an FDA inspection. She mentioned that according to the AHPA, 7% of US VDS facilities are revisited within one year of a previous inspection. Moreover greater than 50% of facilities are inspected again within two years. Some of her recommendations included:
- Having a clear operating protocol for handling regulatory inspections.
- During inspection, immediate investigation and resolution of an issue can help to expedite the process.
- For observations that are not possible to correct during the FDA inspection, preparing the implementation plan for correction before the inspection close-out.
- Making sure that co-manufacturers are compliant with Current Good Manufacturing Practice regulations enforced by the FDA (cGMPs).
- Ensuring that all stages of VDS manufacturing by distributors/brand owners are in compliance with VDS cGMP requirements.
The conference concluded with a panel that included a representative of the FDA and leaders of the VDS associations. One of the final remarks was that the VDS industry will continue to grow in the US because consumers are more invested into self-care and prevention. However, the industry asked the FDA for consistency. For instance, Larissa Pavlick, VP global regulatory and compliance at UNPA, pointed out that reporting from FDA investigators are frequently quite different. Larissa, who worked at the FDA for eight years, mentioned that FDA dietary supplement investigators only get four days of VDS training, so it is hard for them to maintain consistency when their training is so short. The industry also asked why some VDS facilities get audited all the time and requested that the FDA for more consistency on this front.