Requirements for finished product testing for declared daily values of supplements for FDA and SQF?
Hello,
I have a question in regards to finished product testing for dietary supplements that declare percent daily values for vitamins, such as vitamin D, vitamin C, Zinc etc.
Our products are supplement work out powders for the most part, but we have some of this encapsulated now in 2 capsule servings. Our daily value per 2 caps declares, for example, Vitamin D 3 at 25 mcg.
When we send this off for testing it does not come back at that amount, much less. Obviously, because it is a powder the amount is going to vary depending on the sample pulled.
What are the requirements for finished product testing for declared daily values for supplements for the FDA and SQF? Also, HOW would we verify percent DV in a scenerio like this?
Thank you,
SQF states that finished product labels must be accurate and comply with relevant legislation. Here is what 2.4.1.1 says:
There is also this in the SQF guidance:
If there is disagreement between food legislation and the SQF Code, the food legislation always takes precedent. This may include (but is not limited to) applicable maximum residue limits, trade weights and measures, permitted pathogen levels, product description, country-of-origin, nutritional and allergen labeling, etc.
Because of that, I believe it would refer back to the nutritional regulations in 21 CFR 101.9 as the main requirements that you must meet for these nutrient labeling claims.
Isn't there additional guidance / requirements for fat soluble vitamins since excess intake can be hazardous? I thought there was...
At any rate, for sampling and testing I would send an entire unit of the product into the third-party lab and have them do the actual sampling / testing from the unit. If it still comes back with an unexpected low or high value you need to look at your batching and packaging.
Ryan M., I would say that if any ingredient would be hazardous at a certain level, then there must be a limit to ensure the potency isn't too high.
At our company we have special procedures for such ingredients to be extra-sure that the potency in a product dosage will not be excessive.
Matthew
Hi Sarah,
Any comments ?
Thank you for the feedback. I suppose more specifically my question is geared more towards laboratory practices. Our products do not contain levels that are hazardous and we do have measures in place to ensure they do not. However, lab testing methods and validation techniques seem to be the problem when it comes to validating our products . Because our products are blended powders, depending on the sample pulled or capsules pulled for testing the results vary. We do go through a third party accredited lab, and use two separate labs depending on the testing and it seems both labs have confirmed this when it comes to sampling.