Manufacturing guidelines for dietary supplements

It is the manufacturer’s responsibility to see that the supplements they make are standardized, quality products that match the descriptions on their labels. Many manufacturers have always followed careful, consistent production 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.

As of 2010 guidelines are in place for producing dietary supplements. These new guidelines, put out by the Department of Health and Human Services, cover all supplement makers. With these rules, it’s 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 being found to be tainted with real drugs or dangerous substances. Not all manufacturers follow the rules.

How will the new rules affect herbs and supplements?

The new DHHS rules require that dietary supplements follow standards called Good Manufacturing Practices, or GMPs. This means that dietary supplements must:

The companies will still sell their products the same way they did before. But if companies are following the new rules, the supplements will be more likely to contain what is listed on the label. The new rules address the quality of manufacturing processes for dietary supplements and the accurate listing of their ingredients on the label.

It is also important to know what the new rules do not do:

Even so, the improvements in quality and label accuracy will make supplements less likely to cause harm when companies follow these rules.

It is important to remember that, like all laws, the new regulations will not stop dishonest or criminal sellers from selling supplements with false labels. It will be up to the FDA and other law enforcement groups to stop criminal manufacturers once they have been discovered. As quickly as some of these groups have been surfacing, that may be hard to do. See our document called Complementary and Alternative Methods for Cancer Management for more information on quackery and fraud.

New rules on dietary supplements help in some ways, but not others

The good news is that there are now national standards in place that require careful production and help ensure the quality of dietary supplements.

But there are still concerns about what has not changed under the new rules. For instance, there is no requirement that herbs and other substances be tested to find out how they affect the body, or how safe they are.

And despite the rules, you still hear about products that are sold as herbs or “all natural” compounds, but are tainted with drugs or other harmful substances. So it falls to the consumer to gather truthful information about using these products safely.

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. The new FDA rule may not be as stringent as the USP standards, so companies that have followed these standards in the past may keep using them.

You can still look for products that use USP standards. The label may have the initials USP after the name of the product, or it may say that the product conforms to USP standards. Some companies have the initials NF (National Formulary) on their labels. NF is paired with USP, and has standards that more specifically relate to herbs and botanicals.

Supplement makers must still follow FDA rules, but the USP or NF initials indicate that they choose to follow even higher quality standards.