Nutraingredients-USA contacted Mollie Kober of FDA Compliance Group and EAS Consulting and Marion Boardley, who heads her own consultancy, to delve into how personalization creates compliance challenges. They both said that the end goal of this process—truly personalized products formulated for individual customers—could raise a welter of thorny manufacturing issues that touch on testing, records keeping and other questions.
Uptick in interest
Kober has helped set up dietary ingredient manufacturing facilities and has trained facility auditors as well as putting in years as a facility inspector herself. She said she sees this interest in personalized nutrition rising. Companies have been dipping their toes into the personalization pool for while now as a method of differentiation, but Kober said FDA Compliance Group has gotten several inquiries on the subject just in the past few months. Nevertheless, its still early days, and best practices around how to make personalized products in a compliant manner are still forming.
“I have worked over the years with about a dozen companies trying to go that route,” Kober told NutraIngredients-USA. “Lately there has been a little spike and we’ve gotten some inquiries about this in just the past few months.”
The GMP rules for the dietary supplement industry were instituted in three stages, with the last, for the smallest companies, taking effect in 2010. As companies have gotten more experience with the requirements, the pace of inspection observations and warning letters has finally started to subside. The industry seems to have bifurcated along GMP compliance lines. The names of big suppliers and manufacturers are rarely found in the posted warning letters any more. But issues like lack of product specifications, the keeping of accurate and fully compliant manufacturing records, and testing both for incoming raw materials identification and release testing for finished products continue to be mentioned as failures, especially for smaller companies.
Individualized batches complicates manufacturing
The end point of personalization—having a product that as closely as possible represents the perfect intake of micronutrients, phytochemicals and minerals for a given physiology and set of health challenges—is alluring. It promises potentially greater efficacy, and from a market standpoint might also auger well for the commitment of the individual consumer to the brand. Kober said she gets it. While she is not weighing in on the validity of those arguments, she said she does have some concerns about how this could be done and still stay within the GMP lines. If each product is truly unique, then it could be interpreted as being a batch of one, she said. Then all of the requirements that would apply to lots of thousands of products made at a time would apply to that one product, too, she said.
“In the final analysis you are making individual batches for people. That gets complicated in the world of regulation,” she said.
Kober said compounding pharmacies deal with this problem successfully. But they are working with a different set of GMP rules, and of course they are dealing with significantly different price points for the products, too.
In supplements some of the regulatory issues with small batches could be: Do you make two bottles in the ‘batch of one’ and retain the second, as required by GMP regulations? Could the personalized manufacturer then end up with a library of tens of thousands of retained samples, one that matches each consumer’s personalized product? How about testing that individual batch to make sure those personalized dosages meet label claim? Or what about the stability of a brand new formulation? How would one reliably calculate the overages necessary to meet label claim at the end of shelf life?
“We had a customer in Canada who was doing something like this and wanted to bring it to the US,” Kober said. “We told him at the very least that his testing of incoming raw material had to be ironclad.”
Boardley said one way this might work is if the products were, as she puts it, “personalized in a very loose way.”
“You could choose a set of standard dosage increments and make different formulations that way. Or you could have standard dosages, and just recommend that a consumer take two or three if their answers to your questionnaire indicated they should take in more of that nutrient,” Boardley said.
“If you really are making truly personalized products, then to be compliant each product really would have to have its own master manufacturing record and its own batch production record,” Boardley said.
This could of course be done, but Boardley said it would be costly. This would put personalization into the same realm in the supplement world that Rolls Royces occupy in the car market.
“If it’s not expensive it’s not truly personalized. If it is truly personalized, it has to be expensive,” Boardley said.
She said she also doubts that a product based on personalized dosages—100 mg of a nutrient instead of 50 mg, for example—could truly offer significant health benefits. Supplement ingredients by their nature have a big range between an efficacious dosage and their upper safety limits, and putting in overages is a common practice, especially for lower priced ingredients.
“Already when you manufacture you have to put in overages to account for shelf life. And if the personalized product has 50% of the RDI as opposed to 30%, well, that’s not a difference your body will notice the difference. It is kind of a useless distinction,” she said.