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 NatMed Pro editorial team.

USP Verification
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Mostly, but not limited to, vitamins and minerals Source: United States Pharmacopiea (USP)
NSF Contents Certified
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Wide range Source: NSF: Contents Certified
NSF Certified for Sport
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Wide range Source: NSF: Certified for Sport
Empowered By Evidence Accreditation
NatMed Pro Rating: Comprehensive Independent review of processes related to botanical sourcing, batch-to-batch consistency, and clinical research ensures that the specific finished product has been correlated to clinical effect
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Primarily botanicals Source: Empowered By Evidence (EBE)
ConsumerLab Quality Certified
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Not specified Source: ConsumerLab (CL)
Informed Choice
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Not specified Source: Informed Choice
Informed Sport
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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	Per Batch: Third-party testing prior to market release	No	No
Product Types Evaluated: Not specified Source: Informed Sport
BSCG Certified GMP
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Not specified Source: Banned Substance Control Group (BSCG)
BSCG Certified Drug Free
**NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Wide range Source: Banned Substance Control Group (BSCG)
BSCG Certified Quality
NatMed Pro 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 Specific Evidence of Clinical Benefit	Analysis of Specific Products³
Review of Good Manufacturing Practices (GMP)¹	Review of Raw Materials²	Require Specific Evidence of Clinical Benefit	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
Product Types Evaluated: Wide range Source: Banned Substance Control Group (BSCG)

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.