Quality Certifications

In the US, dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA), which defines the role of the US Food and Drug Administration (FDA) in the regulation of finished dietary supplement products and dietary ingredients. Under DSHEA, supplement manufacturers are responsible for ensuring their products are safe and any claims made on product labels are substantiated by evidence. They are also responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) as set forth in 21 CFR 111.

Unfortunately, a number of high-profile events over the past two decades have raised concerns about the quality of supplements available on the market. The main concerns relate to whether product labels accurately list ingredients and ingredient quantities, as well as the possible presence of unwanted drugs or contaminants.

In an effort to demonstrate a commitment to quality, some manufacturers have chosen to pursue third-party quality certification. There are currently a number of different organizations that offer a quality certification program for supplement manufacturers. The details of each of these programs, as well as their ability to truly confirm product quality, varies greatly.

The following chart compares and contrasts the major components of each third-party certification program. It also provides a general statement on the level of rigor associated with that certification, as determined by the Natural Medicines editorial team.

USP Verification

Natural Medicines Rating: Comprehensive

Strict processes involving on-site facility audits and regular off-the-shelf testing ensure product quality

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
Annual: On-site audit No No Annual: Off-the-shelf, third-party testing Annual: Off-the-shelf, third-party testing No Annual: Off-the-shelf, third-party testing Annual: Off-the-shelf, third-party testing
NSF Contents Certified

Natural Medicines Rating: Comprehensive

Strict processes involving on-site facility audits and regular off-the-shelf testing ensure product quality

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
Annual: On-site audit No No Annual: Off-the-shelf, third-party testing Annual: Off-the-shelf, third-party testing No No Annual: Off-the-shelf, third-party testing
NSF Certified for Sport

Natural Medicines Rating: Comprehensive

Strict processes involving on-site facility audits and regular off-the-shelf testing ensure product quality; additional testing for banned substances of value for athletes and others

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
Biannual: On-site audit No No Annual: Off-the-shelf, third-party testing Annual: Off-the-shelf, third-party testing Annual: Off-the-shelf, third-party testing No Annual: Off-the-shelf, third-party testing
NHSF Accreditation

Natural Medicines Rating: Comprehensive

Independent review of processes related to botanical sourcing, batch-to-batch consistency, and clinical research ensures the presence of an extract that has been correlated to clinical effect

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
Annual: Off-site paper review Annual: Confirms compliance with GACP At least one well-designed randomized, controlled trial Annual: Paper review of manufacturer testing No No Annual: Paper review of manufacturer testing Annual: Paper review of manufacturer testing
ConsumerLab Quality Certified

Natural Medicines Rating: Comprehensive

Regular, off-the-shelf testing confirms product contents and quality; lack of GMP review limits assurance related to quality consistency

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
No No No Annual: Off-the-shelf, third-party testing Annual: Off-the-shelf, third-party testing No Annual: Off-the-shelf, third-party testing No
Informed Choice

Natural Medicines Rating: Insufficient

Loose review processes and lack of confirmation of product contents does not ensure product quality

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
One-time: Off-site paper review One-time: Paper review of processes No No No Monthly: Off-the-shelf, third-party testing No No
BSCG Certified GMP

Natural Medicines Rating: Insufficient

Although on-site review helps to ensure compliance with GMP, lack of product-specific testing does not ensure product quality

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
Every 2 years: On-site audit No No No No No No No
BSCG Certified Drug Free

Natural Medicines Rating: Insufficient 

Does not confirm that product contents align with product label; quality cannot be confirmed

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
One-time: Off-site paper review No No No No Monthly (or per batch): Off-the shelf, third-party testing No No
BSCG Certified Quality

Natural Medicines Rating: Insufficient

Does not confirm that product contents align with product label; quality cannot be confirmed

Review of Good Manufacturing Practices (GMP)1 Review of Raw Materials2 Require Evidence of Clinical Benefit Analysis of Specific Products3
Confirms ingredient identities and quantities match product label Looks for presence of contaminants (heavy metals, pesticides, microbes, etc) Looks for presence of drugs or banned ingredients Confirms appropriate dissolution/ disintegration Confirms batch-to-batch consistency
One-time: Off-site paper review No No No Annual* No Annual (ONLY for raw material certification requests) No

1Review of GMP: This may be done by conducting a paper review of processes or conducting an on-site facility audit (considered the gold standard)

2Review of Raw Materials: Involves an evaluation of the standards associated with the sourcing of raw materials. For botanicals, this includes confirming consistency in harvesting and processing practices. Good Agricultural and Collection Practice (GACP) standards from various organizations can be used as a benchmark for determining quality sourcing of botanical ingredients.

3Analysis of Specific Products: By testing individual products, third-party laboratories can confirm that the product contents match the label, that there are no contaminants present, that there are no banned substances present, and that the product dissolves adequately to allow for systemic absorption. However, most quality certifications do not conduct all of these tests; only certain tests are conducted depending on the specific certification.