By Pattie Stechschulte
Standing in the aisle of the health store, you feel overwhelmed by the sheer number of different manufacturers making nutritional supplements. How do you advise patients on how to
choose
the best product? How do you determine which is the best manufacturer? To help in the confusion, it is best to learn how the industry is regulated and how to spot the manufacturers that focus on producing the highest quality.
A Little Background
In 1994, the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA) which defined the term “dietary supplement.” According to the law, a “dietary supplement” is any product taken by mouth that contains a “dietary ingredient” intended to supplement the diet which may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars and metabolites.
Since nutritional supplements are considered a food item, they are under the oversight of the Center for Food Safety and Applied Nutrition at the Food and Drug Administration (FDA). This new law, which amended the Federal Food, Drug and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.
According to the FDA, a company is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading.
“From our position, when we introduce a product, it has already gone through a very rigorous and intensive scientific review process internally, using both internal scientific resources as well as our own outside scientific advisors. By the time we bring something to market, we have already verified that there is science behind the product and the claim,” said Doug Jones, public relations manager, Pharmavite LLC, which manufacturers nutritional supplements under the labels of Nature Made, SAM-e and Nature’s Resource.
The Power and Oversight of the FDA and FTC
Once a supplement is available to the public, the FDA is now responsible for making sure the product is safe and that the product label information is truthful and not misleading. They also monitor the product’s packaging, inserts and other materials distributed at the time of sale.
The Federal Trade Commission, under the Department of Justice, works with the FDA in regulating nutritional supplements, but they monitor any and all advertising to ensure that consumers get accurate information.
“Critics, who say that dietary supplements are ‘unregulated,’ generally mean that supplements are not regulated like drugs. Supplements are not drugs, and thus are not generally pre-approved like drugs by government agencies,” said Judy Blatman, vice president of communications, Council for Responsible Nutrition. “That is not to say they do not undergo rigorous review by reputable companies that work hard to ensure the safety and benefit of their products. In fact, CRN’s members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.”
Rules on “New Dietary Ingredients”
Another highlight from the DSHEA Act is that manufacturers are required to notify the FDA when it intends to bring a supplement that contains a “new dietary ingredient” to the market. They must prove to the FDA that the ingredient is “reasonably expected to be safe for use in a dietary supplement.”
“That is the only thing that supplements need to get approval for—new ingredients, and there is not too many of those, because just about everything has been done. You have to be very drug-like, in terms of toxicology. So they are treating the new dietary ingredients as if they are drugs. The FDA has recently beefed up that staff,” said Bucci.
There was no database or official list of dietary ingredients sold prior to the passing of the DSHEA Act in 1994, so manufacturers must prove that the dietary ingredients is not new by doing their own research.
“If you can find the name of something on a label pre-1994, you are okay. That is why many things were grandfathered all of a sudden, even though they weren’t really popular,” said Bucci.
Good Manufacturing Process Guidelines
“Under the DSHEA Act of 1994, the FDA was suppose to publish the GMP (good manufacturing practices), that is what will give them the actual regulatory keep, but we are still waiting for them to be published,” said Jones. “We are aware of the proposed guidelines, and our manufacturing standards exceed the proposed standards.”
“There are so many thousands of individual supplements and tens of thousands of batches that it is impossible to oversee it all the time, so the GMPs will make it easier to inspect manufacturing plants,” said Bucci. “I think it is good because it will clean up the industry. The big companies are already doing it and have been because that is the only way you know what you are doing. That will also help public credibility.”