Jump to content

  • Quick Navigation
Photo
- - - - -

FDA tolerance on serving size supplement capsules weight


  • You cannot start a new topic
  • Please log in to reply
2 replies to this topic

Sarahb3339

    Grade - MIFSQN

  • IFSQN Member
  • 86 posts
  • 2 thanks
2
Neutral

  • Earth
    Earth

Posted 14 October 2021 - 09:55 PM

Hello,

 

I am trying to find information on serving size in supplement capsules .  Does the FDA have an amount or percent that the serving size can be "off" from what the label claims?  For example if serving size is 3 caps at 1200 mg and it actually turns out to be 1000 mg when weighed what is the allowance?



Scampi

    Fellow

  • IFSQN Fellow
  • 3,904 posts
  • 1062 thanks
732
Excellent

  • Canada
    Canada
  • Gender:Not Telling

Posted 15 October 2021 - 01:39 PM

are you concerned about weight or potency?   

 

being 200 mg out seems excessive to me, and that difference would be large enough so that your label claims are now not accurate

 

https://www.fda.gov/...ary-supplements

 

Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?

Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

What is FDA's oversight responsibility for dietary supplements?

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occasional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

Does FDA routinely analyze the content of dietary supplements?

In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.


Please stop referring to me as Sir/sirs


Sarahb3339

    Grade - MIFSQN

  • IFSQN Member
  • 86 posts
  • 2 thanks
2
Neutral

  • Earth
    Earth

Posted 15 October 2021 - 03:18 PM

I am wondering if there is any clearance or percent off that the serving size can be per FDA.  I am concerned about weight.  The only daily value on the label is vitamin C.  All other ingredients are herbals.  If there isn't I suppose I am looking at reworking all these capsules dumping them out one by one. 






0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users