Manufacturing guidelines for dietary supplements
It’s the manufacturer’s responsibility to see that the supplements they prepare are standardized, quality products that match the descriptions on their labels. Many manufacturers have always followed careful, consistent standards and sell only high-quality, correctly labeled supplements. But less honest manufacturers, or those who are less careful, make supplements that contain little or none of the products listed on the label. Some supplements even contain a larger dose than the label lists, possibly due to poor quality controls. There have been reported cases of toxic products, too.
Guidelines put out by the Department of Health and Human Services cover all supplement makers as of 2010. With these rules, it might be more likely that supplements from careful manufacturers contain what the label says they do. But it’s important to know that, even though these rules are in effect, many supplements are still found to be tainted with real drugs or dangerous substances – not all manufacturers follow the rules.
How the rules affect herbs and supplements
The DHHS guidelines require that dietary supplements follow standards called Good Manufacturing Practices, or GMPs. This means that dietary supplements must:
- Be produced in a quality manner
- Not contain any contaminants or impurities
- Be labeled with the ingredients that are actually in the product
The companies still sell their products the same way they did before. But if companies are following the 2010 guidelines, the supplements will be more likely to contain what’s listed on the label. These guidelines also address the quality of manufacturing processes for dietary supplements and the accurate listing of their ingredients on the label.
It’s also important to know what the guidelines do not do:
- They do not limit consumers’ access to dietary supplements.
- They do not address the safety of the supplements’ ingredients.
- They do not address the supplements’ effects on the body as long as good manufacturing processes are used.
Even so, the improvements in quality and label accuracy should make supplements less likely to cause harm when companies follow these rules.
Also remember that, like all laws, the DHHS guidelines will not stop dishonest or criminal sellers from selling supplements with false labels. You’ll still hear about products that are sold as herbs or “all natural” compounds, but are tainted with drugs or other harmful substances. While it’s up to the FDA (US Food and Drug Administration) and other law enforcement groups to stop criminal manufacturers once they have been discovered, it falls to the consumer to gather truthful information about these products.
See Complementary and Alternative Methods and Cancer for more information on quackery and fraud.
USP or NF quality standards used by many companies
The US Pharmacopeia (USP) is an independent organization dedicated to quality control for the strength, quality, and purity of pharmaceuticals. The USP began publishing standards for dietary supplements in 1997. These standards focus on the strength, quality, purity, packaging, and labeling of dietary supplements. They are updated yearly. The USP also does product testing and site visits for companies who join their program.
Makers of dietary supplements are not required by law to follow USP standards, but many of them have chosen to do so. You can still look for products that use USP standards. These supplements all have the USP Dietary Supplement Verified mark on their labels.
Supplement makers are all supposed to follow FDA rules (discussed in the section called “ Dietary supplements are considered safe until proven unsafe”), but the USP mark indicates that they choose to follow even higher quality standards.
- What you need to know first about dietary supplements
- Risks and side effects of dietary supplements
- Dietary supplement advertising and promotion
- Talking with your doctor about dietary supplements
- Common misconceptions about dietary supplements
- FDA regulation of drugs versus dietary supplements
- Manufacturing guidelines for dietary supplements
- Understanding the claims on dietary supplement labels
- Choosing and using dietary supplements safely
- To learn more
Last Medical Review: March 31, 2015 Last Revised: March 31, 2015