6 replies to this topic

[Sarahb3339]

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,  

[matthewcc]

Sarahb3339, is this for the United States?  If so, for FDA, the rule is as follows:

 

If you're adding that specific nutrient (Class I nutrient, defined in (3)(i)), then it must be at least 100% of the amount claimed on the label [21 CFR 101.9(g)(4)(i)].  If it a naturally occurring nutrient (Class II nutrient, defined in (3)(ii)), then the nutrient content must be at least 80% of the value declared on the label [21 CFR 101.9(g)(4)(ii)].

 

 

 

https://www.ecfr.gov...5#se21.2.101_19

 

 

(3) Two classes of nutrients are defined for purposes of compliance:

 

(i) Class I. Added nutrients in fortified or fabricated foods; and

 

(ii) Class II. Naturally occurring (indigenous) nutrients. When a nutrient is naturally occurring (indigenous) in a food or an ingredient that is added to a food, the total amount of such nutrient in the final food product is subject to class II requirements, except that when an exogenous source of the nutrient is also added to the final food product, the total amount of the nutrient in the final food product (indigenous and exogenous) is subject to class I requirements.

 

(4) A food with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, polyunsaturated or monounsaturated fat shall be deemed to be misbranded under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the act) unless it meets the following requirements:

 

(i) When a vitamin, mineral, protein, or dietary fiber meets the definition of a Class I nutrient, the nutrient content of the composite must be formulated to be at least equal to the value for that nutrient declared on the label.

 

(ii) When a vitamin, mineral, protein, total carbohydrate, polyunsaturated or monounsaturated fat, or dietary fiber meets the definition of a Class II nutrient, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. Provided, That no regulatory action will be based on a determination of a nutrient value that falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.

 

Percent DV is calculated using the table in 21 CFR 101.9( c)(8)(iv) based on the intended consumer of the product--i.e., whether it's an adult, infant, etc.

 

Matthew

Edited by matthewcc, 08 October 2020 - 03:25 PM.

[matthewcc]

SQF states that finished product labels must be accurate and comply with relevant legislation.  Here is what 2.4.1.1 says:

 

2.4.1.1 The site shall ensure that, at the time of delivery to its customer, the food supplied shall comply with the legislation that applies to the food and its production in the country of use or sale. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description, net weights, nutritional, allergen and additive labeling, labeling of identify preserved foods, any other criteria listed under food legislation, and to relevant established industry codes of practice.

 

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.

[Ryan M.]

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.

[matthewcc]

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.

 

It seems like that's what's said in the definition of adulteration in 21 USC 342:

A food shall be deemed to be adulterated— 

(f)Dietary supplement or ingredient: safety

(1)If it is a dietary supplement or contains a dietary ingredient that—

(A)presents a significant or unreasonable risk of illness or injury under—

(i)conditions of use recommended or suggested in labeling, or...

 

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

[Charles.C]

Hi Sarah,

 

Any comments ?

[Sarahb3339]

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.