Be prepared – the inspector is coming!
The Food and Drug Administration continues to inspect dietary supplement companies under the agency’s current good manufacturing practice rule, 21 CFR 111. And FDA has developed a record that shows a significant need for improvement by supplement companies.
FDA inspectors have observed manufacturers out of compliance with such basic requirements as creating master manufacturing and batch production records and establishing and meeting specifications for finished products. Many of these basic flaws may have been expected for an industry encountering an entirely new and much more complex cGMP rule, but there have also been surprises.
One area where FDA’s inspections differ from the industry’s initial expectation is its position that companies that market under their own brands products made by contract manufacturers must know during an inspection “what and how manufacturing activities are performed.” And even though 21 CFR 111 specifies that organoleptic analysis is an allowable test for verifying identity, FDA has challenged companies for use of this method, especially for finished products.
gThe obvious lesson is that industry must continue its cGMP education. AHPA is planning to assist in this education in 2014, and will produce webinars on specific cGMP related topics and add to an existing library of standard operating procedure (SOP) templates. AHPA will also launch its online Botanical Identity References Compendium website to provide tools for identifying herbal ingredients, as well as a database of cGMP inspection records.
GMO labeling – Mandate or marketplace?
The supplement industry lacks consensus on the issue of GMO labeling. Some activists in our community are strong advocates for establishing state or federal laws that would require mandatory disclosure of ingredients that are derived from GMO crops, including some excipients that are made from corn or soy. Other companies have expressed opposition to any such legislative mandate, arguing that the additional costs that would be associated with segregating materials will lead to increased retail pricing to address an issue that they believe is already adequately managed under existing federal law.
In the last two years the cost of selling these opposing messages is reported to have exceeded $80 million, just in the states of California and Washington where voter initiatives were defeated by thin margins. And while federal legislation has been introduced in both the Senate and the House there does not appear to be sufficient Congressional support to ensure passage.
In order to break this stalemate and respect consumer demands to know what’s in their food (and supplements), AHPA has advocated for development of a federal voluntary standard, perhaps modeled on the National Organic Program. This week’s announcement that General Mills intends to reformulate its iconic Cheerios to be a non-GMO product is a strong indication that big food companies are listening to their customers and that voluntary disclosure of absence of GMO ingredients may be tenable.
The medium is the message – and the message is misinformation
The drumbeat of “news” that purports to prove that dietary supplements are ineffective, dangerous, or poorly regulated has been nearly nonstop for the past several months. Sensational and often inaccurate or misleading articles were published in 2013 in JAMA Internal Medicine, USA Today, and the New York Times, among others. AHPA was able to have letters to the editors placed in the three above-cited publications to correct the record, and will continue to be vigilant in 2014.