Consumers’ access to essential dietary supplements is at risk of being taken away. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the government gave individual manufacturers the control of developing and distributing dietary supplements. The DSHEA is now being challenged and if new laws become effective, dietary supplements will become subject to regulations and several products may become eliminated all together.
Bill Abraham and Sandy Ochsner, owners of Mountain Valley Health Foods in Franklin, are opposed to the new regulations because they believe it is taking away a basic right. “The worst part about the new regulations is they are trying to take away our right to choose,” said Ochsner. “We can choose to go out and buy things like beer and cigarettes, but they are trying to regulate what natural products we have access to.”
“It’s a shame that most of what is made naturally and comes from the earth, they want to regulate or make illegal, but they don’t worry about the products that are made by man,” said Abraham. “The government is supposed to represent the people, but it seems that in this case they are representing the corporations.”
Currently, the Food and Drug Administration (FDA) is charged with regulating both finished dietary supplement products and dietary ingredients. Dietary products are regulated using a separate set of regulations than those established for conventional food and drug products which allow the ultimate responsibility to be on the manufacturers.
President Clinton signed the DSHEA into law in response to previous threats on regulating dietary supplements. Before this time, dietary supplements were subject to the same regulatory requirements as were other foods. The new law, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements.
Congress defined the term “dietary supplement” in the DSHEA of 1994. According to Congress, a dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
Under DSHEA, each firm is individually 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. Because the manufacturers are held accountable, dietary supplements do not need approval from the FDA before they are marketed.
If claims are brought against a manufacturer, the FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Under DSHEA, manufacturers do not need to register new products with FDA nor get FDA approval before producing or selling dietary supplements.
Under the FDA Final Rule 21 CFR 111, all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices (cGMPS) for quality control. In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.
Manufacturers are also required to register themselves pursuant to the Bioterrorism Act1 with the FDA before producing or selling any dietary supplements. In June 2007, FDA published comprehensive regulations for Current Good Manufacturing Practices for those who manufacture, package or hold dietary supplement products. These regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements in an attempt to further protect the consumer.
In addition, the FDA is also responsible for including product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission is charged with regulating dietary supplement advertising and marketing.
Government attempting to do away with DSHEA
In 2010, Senate Bill S.3002, a bill entitled, The Dietary Supplement Safety Act, was the first unsuccessful attempt to change DSHEA and ultimately take away the consumers’ health choice and placing them under government control.
Senate Bill S.3002 was sponsored by Senator John McCain (R-AZ) with the intent of amending the FFDCA to deem dietary supplements which are manufactured, packaged, held, distributed, labeled or licensed by a dietary supplement facility that is not registered with the Secretary of Health and Human Services to be adulterated.
The bill called for yearly registration of dietary supplement facilities in an attempt to better monitor production, and outlined fines and other civil penalties in the event the new regulations were violated.
Lobbyists and legislators in Washington came out in opposition to the bill, which has caused it to stall. Organizations opposing the bill included Association of American Physicians and Surgeons, National Products Association, Vitamin-Freedom, American Herbal Products Association, and nearly a dozen other advocacy groups.
The bill has stalled in Congress, and other bills have since been pushed forth to begin regulating dietary supplements.
In July 2011, Senate Bill 1310, or the Dietary Supplement Labeling Act of 2011, was introduced by Sen. Richard Durbin (D-Ill.), which was established with the intent of placing restrictions on dietary supplements.
According to Ochsner, the newest legislation poses the most serious threat to the health food industry, not only for business owners like herself, but also for consumers. “What people may not realize is that it will affect so many things, not just business owners,” said Ochsner. “The new regulations may prevent people from being able to walk in a store and purchase basic supplements like Vitamin C.”
“They are trying to take away our right to take care of ourselves,” said Ochsner. “Medication is regulated by the FDA, yet it contributes to the death of many people each year.”
Abraham noted that in 2009 out of all the deaths reported to the Center for Poison Control, not one was caused from supplements, but many died from FDA approved drugs.
If approved, the bill would direct the Department of Health and Human Services to create a list of ingredients and proprietary blends of ingredients that “could cause a potentially serious adverse events.”
The new piece of legislation also directs the FDA to impose mandatory warning labels on ingredients decided by the government to be potentially harmful.
Advocacy groups and organizations such as the Natural Products Association oppose Durbin’s bill because of the overly broad language and potential to allow the government to regulate supplements beyond the current, effective rules. The Natural Products Association is adamant the new bill would impose needless new regulations on supplement makers in an attempt to address the issue of manufacturers who mislabel their food and drink products as dietary supplements.
The FDA issued a 47-page draft guidance regarding New Dietary Ingredients (NDIs) without seeking the input from the Health Food/Natural Product industry or from consumers. Organizations opposing the NDIs fear that if the newly proposed guidelines are implemented as written, it will drastically change the FDA’s previous interpretation of federal law in a way that could jeopardize access to thousands of products and seriously impact the research and introduction of new health products.
Under the NDIs, any supplement that contains a new ingredient added after 1994 will be required to be pre-approved by the FDA, meaning several supplements that have been available to consumers for 17 years may become obsolete.
If Congress votes in favor of allowing the government to regulate dietary supplements, lobbyists fear that the United States will lose more than half of their dietary products, exactly in the same manner Canada has.
In the past five years, less than half of submitted license applications for dietary supplements have been approved in Canada, significantly reducing the types of products available in the Canadian market. The highly restrictive Health Canada scheme is controlled by the government and is making it increasingly more difficult for Canadians to receive dietary supplements to maintain their health.
According to Ochsner, if the regulations are approved, thousands of jobs will be lost, during a time that already has record high unemployment rates. “With unemployment numbers the way they are and in an economy that is obviously struggling, these regulations will mean the loss of many more jobs and higher unemployment numbers throughout the country.”
Abraham noted that Gaia Herbs in Brevard is dedicated to the health food industry and the new regulations could potentially have devastating effects on the business.
Those opposing stricter government regulations on dietary supplements are encouraged to call the capitol switchboard at 202-224- 3121 and tell your senators and representatives why they should vote against the new bills.