Quality Control – FDA Qualified GMPs & TruLabel Supplements
Taking Supplementation Seriously
Until recently, the only way to assess the quality of a supplement (short of spending a personal fortune on lab testing), was subjective data such as brand reputation, marketing claims, and personal experience.
The recent definition of the Good Manufacturing Practices (GMPs) for dietary supplement manufacturers by the Food and Drug Administration has significantly improved how supplement quality is viewed. The 1995 Dietary Supplement Health and Education Act (DSHEA), in addition to legally defining supplements and setting guidelines for their sale and marketing, also provided for a set of regulations governing their proper manufacture. It wasn’t until 2007, however, that these rules (the GMPs), were finally issued by the FDA.
The GMPs are a set of requirements and expectations for the quality manufacturing, testing, and storage of dietary supplement products. They were phased in over a three year period; as of June 2010, all manufacturers are expected to be GMP-compliant. GMPs are a great benefit to consumers, and promise to dramatically improve confidence in their dietary supplement choices.
While generally viewed as a positive step, the implementation of the FDA GMPs is relatively new, and the regulations themselves still contain areas (such as testing requirements) that are not fully defined. It may also be some time before the FDA gets around to assessing the GMP compliance of every dietary supplement manufacturer, if they even choose to do so. Therefore it is useful to be familiar with other resources to determine the quality of a supplement product; this article outlines some of the most common.
What is Quality in a Dietary Supplement?
There are several ways to define quality for a supplement, but conventional assessments of supplement quality usually concentrate on two areas:
1. Adherence to label claims. It is fairly obvious that a quality supplement should contain the amounts of each ingredient (within an acceptable margin of error) stated in theSupplement Facts panel.
2. Freedom from adulteration. Although adulteration suggests some sort of malicious intentional contamination, in terms of GMP, it is officially used to describe any contamination of a dietary supplement product. This includes:
- Elevated levels of toxic metals (lead, mercury, cadmium, arsenic, etc.),
- High levels of microbes,
- Toxins, natural or man-made (pesticides, herbicides, chemical wastes).
However, what one considers to being a good or effective supplement product does not have to be one with the greatest quality. There are many products in the marketplace that are made with quality ingredients under strict manufacturing guidelines, but contain small amounts and combinations of ingredients that are less than the documented effective doses, yet still work well.
Ingredient quality and manufacturing quality can be treated as separate measures that must both be considered when choosing a quality supplement. A good manufacturer cannot make a quality supplement using poor quality ingredients, just as the best ingredient cannot add to the quality of a product if the manufacturer cannot reliably put the correct amount in the bottle.
Identifying Quality in a Supplement
Third party product testing, directly demonstrate that the product adheres to label claims and represent the best affirmation of product quality. Unfortunately, only a fraction of the supplement market will ever get an independent test, so the savvy consumer must often look for other quality indicators when making a quality assessment.
Standardization: An indirect measurement of ingredient quality, standardized ingredients contains a measurable amount of a particular compound. This is most often applied to extracts. For example, milk thistle contains hundreds of different compounds; the most active for liver detoxification is the compound silymarin. Therefore, to guarantee the desired activity of milk thistle, manufacturers extract and process the seeds of the milk thistle in a way that preserves a consistent, measurable amount of silymarin (as in “Milk thistle, standardized to 68 percent silymarin”). However, not all herbs and nutrients are, or can be, standardized.
Branded ingredients: These refer to manufacturers who have a “specialized”manufacturing techniques or animal or human clinical trials. While not a direct quality measurement, branded ingredients are usually better tested.
Pharmacopoeiae: These are standards (monographs) developed and maintained by independent organizations of scientists as recommended guidelines for manufacturing quality. The most familiar in the U.S. is the United States Pharmacopoeia (USP). These are not independently verified but assumed to be a higher and labeled (ex: glutamine USP).
The USP also maintains the USP Verified Dietary Supplement Ingredient Program, a voluntary program in which manufacturers can have individual ingredients verified for manufacturing consistency, meeting label claims for purity, potency, and quality, and acceptable limits of contamination. The USP website maintains a list of ingredients and manufacturers which have been verified under this program.
The Best Indicators
1. GMP Manufacturing Certification: This is FDA regulated Good Manufacturing Practice. It isthe best assurance of quality! All dietary supplement manufacturers and distributors are required to adhere to the FDA GMPs. However, most have not been audited by the FDA, so their compliance is not necessarily guaranteed. Therefore, there are organizations that perform independent audits to certify compliance.
cGMP: The set of current, up-to-date methodologies, practices, and procedures mandated by the Food and Drug Administration (FDA) and the Internal Conference on Harmonization (ICH) which are to be followed in the testing and manufacture of pharmaceuticals. The set of rules and regulations promulgated and enforced by the FDA and other countries’ regulatory authorities to ensure the manufacture of safe clinical supplies. All Novasep API and biopharmaceutical manufacturing facilities operate under current Good Manufacturing Practices (cGMP).
2. Third Party Testing: This is also strong evident of individual product quality. However, very few companies do this because it adds considerable cost to the products, usually not practical – especially if it is a GMP certified manufacturer.
The USP Dietary Supplement Verification Program, the TruLabel program and ConsumerLabtests supplements. Products which pass testing bear their seals.
The TruLabel Program is a dietary supplement label registration and random-testing program. This internal oversight program was designed to create a high level of confidence with retailers and consumers that products sold in the marketplace are accurately labeled.
The TruLabel program provided database information to defend the industry when elected officials and regulatory agencies have questions and/or make incorrect statements about products. The random testing has been beneficial to the industry also as the test results have been used to backup concerns about products or ingredients in the marketplace.