FDA 21 CFR 117 

FDA 21 CFR 117 does not specifically require importers and raw material suppliers to test raw materials. This regulation is broader than CFR 111 which is specific to dietary supplement manufacturing.

For this reason, in following CFR 117, importers of raw materials used in supplements often bypass conducting their own testing, instead relying on Certificates of Analysis (COAs) provided by overseas manufacturers. Unfortunately, these tests often employ incorrect methods and very often do not reflect current lot number. In other words, to be clear, importers do not test raw materials. They copy and paste their names on COAs. They rely on COAs from farmers, milling houses and factories abroad. Those analysis are extremely flawed and often worse than no testing at all since they give a false sense of safety. Examples are below.

Incorrect test methods:
Suppliers typically use FTIR instead of HPTLC or HPLC. Cheap analytical methods are often used. And even if correct methods are used, obvious mistakes are often made.

Featuring an old lot number:
Suppliers typically show a very favorable test result from a lot within a year, then they sell you another lot that has problems.

The problem with bulk suppliers:
We find that bulk supplements suppliers that sell by the pound directly to consumers and industry typically do not pay any attention to the identity of the powders they carry. They also lack quality control because their products often lack lot numbers and if they display a lot number it often does not match the COA. They often do not include COA without you paying extra. Worse, once you get the COA it’s unusable either because it’s a copy of a copy from a different lot, etc. You see those companies buy in bulk from the importers that do no analysis of the raw materials they sell and then they forward the fake analysis.

Turmeric as an example:
Hundreds of raw materials, including popular items like turmeric, are increasingly being sold by the pound directly to consumers without adequate testing, posing significant health risks. They are not tested and could contain lead either naturally in the soil or added to enhance the color of turmeric.

How do you protect your brand?
The lack of thorough testing and quality assurance for bulk raw materials underscores the critical need for brand owners awareness and caution. They should make sure their manufacturers follow FDA 21 CFR 111. 

• 100% of all lots of botanicals should be tested for ID on HPTLC
• Microbiological tests should be conducted
  – including pathogen testing in a BSL-2 lab
• Heavy metal analysis should be conducted prior to encapsulation
• Potency should be analyzed as appropriate

FDA 21 CFR 111

FDA 21 CFR 111 is a critical regulation that mandates proper testing of raw materials used in dietary supplements. This regulation requires manufacturers to verify the identity, purity, strength, and composition of their raw materials to ensure they meet specified standards. By conducting thorough testing, manufacturers can maintain the quality and safety of their products, preventing contamination and ensuring that the final product accurately reflects its labeling.

The testing requirements under 21 CFR 111 are essential for safeguarding consumer health and maintaining the integrity of dietary supplements. Compliance with this regulation helps manufacturers avoid the use of substandard or contaminated materials, reducing the risk of adverse health effects for consumers. By adhering to these standards, manufacturers not only protect consumer safety but also uphold their reputation for quality and reliability in the marketplace. Overall, 21 CFR 111 plays a vital role in ensuring that dietary supplements are safe, effective, and compliant with regulatory expectations.