This week’s big news across the global nutrition and supplements industries includes the reversal of defunding of the landmark Women’s Health Initiative (WHI), Japan’s new probiotic rules and FDA’s exploration of ways to outsource facility inspections.
Women’s Health Initiative funding canceled, not canceled
Nutrition researchers in the U.S. let out a collective sigh of relief last week when the Department of Health and Human Services (HHS) announced that it was not defunding the landmark Women’s Health Initiative (WHI) after all.
A couple of days earlier, a funding announcement posted to the WHI website communicated that HHS intended to cut contracts with all four of the initiative’s regional data collection centers in September and possibly to the clinical coordinating center in January.
On Thursday, HHS issued a statement that WHI studies represent critical contributions towards better understanding women’s health and that the National Institutes of Health (NIH), a part of HHS, was “taking immediate steps to ensure the continuity of these studies”.
Launched in the 1990s by Bernadine Healy, MD, the first female director of the NIH, the Women’s Health Initiative was designed to fill a research gap on disease prevention in older women.
Today, the WHI database and bio sample repository is the largest source for further study of women’s health.
Japan tightens dairy rules to improve standardization, probiotic fortification safety
Japan announced the introduction of new food safety documentation rules for milk product manufacturers, as well as functional foods, drinks and infant formula containing probiotics.
It will be mandatory for companies to submit documents on name and address of the manufacturing facility, product name, ingredients used and the mixing ratios.
“For all products containing probiotic ingredients, additional documentation is required to ensure food safety,” stated the Consumer Affairs Agency (CAA). Japan recently transferred the administration of national food safety standards from the Ministry of Health, Labour and Welfare (MHLW).
“Food safety is the primary concern here, and for infant foods or formula, strains must be of the genus Bacilus subtilis and the genus, species and strain must be genetically identified for safety,” CAA added.
“For all foods, the probiotic bacteria must have antibiotic resistance that is comparable or less than that found in other strains of the same species, the amount of D-lactic acid produced must be equivalent to other strains, and no harmful secondary bile acids must be present.”
FDA explores novel approaches to facility inspections for cGMPs
A recently leaked memo from the U.S. Department of Health and Human Services (HHS) indicated that U.S. Food and Drug Administration was planning to outsource routine inspections of food facilities (which includes dietary supplement facilities) to the states.
A top executive at the Agency also told an industry group recently that FDA could be open to leveraging external data from mature dietary supplement audit programs to inform FDA inspectional planning process
The FDA published the final rule for current good manufacturing practice requirements (cGMPs) for dietary supplements in 2007, with implementation for all companies taking full effect in 2010. Fifteen years on, cGMP inspections are still revealing compliance issues for some companies.
The agency averages between 500 and 600 inspections per year (the exception being 2020 and 2021 when the pandemic severely limited inspection numbers).
During a presentation at the recent GRMA Summit in Chicago, hosted by the Global Retailer Manufacturers Alliance, Dr. Cara Welch, director of the FDA’s Office of Dietary Supplement Programs (ODSP), said that there are a number of third-party audit programs that were in place before FDA published the final rule in 2007.
“Are there opportunities to take the information that might come about as part of the third-party audit and apply it into FDA inspectional planning process? I don’t have a really clear answer,” she added, but noted that she has had discussions with GRMA and other stakeholders on the opportunity to leverage that external data.
“I don’t have explanation of how this might happen, but absolutely, I think FDA would appreciate continued discussion about some of these opportunities to leverage this data there.”