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You may have heard or seen news reports recently that have questioned the regulation of dietary supplements. We wanted to provide a simple outline for you, as Paul Harvey would say, to see the rest of the story.
| What Critics Say: | Facts: | NOW's Response: | |
| Supplement companies are selling pharmaceutical drugs in their product. | Products containing pharmaceutical drugs are not Dietary Supplements. They are unapproved drugs and are subject to FDA enforcement to remove them from the market. For more information on this, see www.npainfo.org. | NOW tests against known adulterants and has even published and shared our advanced method to test for certain types of drugs when screening raw materials. | |
| Many companies in the supplement industry are “liars, cheats and thieves." | Our industry trade associations have promoted and pioneered adoption of Good Manufacturing Practices (GMPs), adverse event reporting (AER), the use of label cautions, and have held numerous educational events to help manufacturers comply with regulations. | NOW thoroughly tests all of its products to meet all regulations and laws as required by the FDA, and even goes beyond this. | |
| Dietary supplement companies make false claims of efficacy, including illegal drug claims. | There have been unsubstantiated claims made for some supplements, but there are federal regulations that may have been violated by those companies and some have been cited by the FDA and FTC, using their enforcement powers. | NOW utilizes a scientific review staff to create all label claims and vet all marketing materials to assure accuracy and validity. Our professional staff do not allow any drug claims or unsubstantiated label claims. | |
| Dietary supplement adverse events* are underreported by supplement companies. | The FDA has cited companies for failing to do this, and this is something that has been included in FDA plant inspections. However, the high estimates cited as comparison to actual reports typically predate the adoption of mandatory adverse event reporting in 2008. | NOW records every adverse event and reports all serious ones to the FDA, as required by law. | |
| Dietary supplements are worthless, or at worst, harmful. | Vitamins and minerals are proven to prevent nutrient deficiency diseases and other negative health effects. The FDA has approved qualified health claims for some vitamins and minerals. Poison Control Center data consistently show close to zero accidental deaths from taking supplements, and the number of serious adverse events remains low. | NOW's record of product safety and relatively few adverse events shows otherwise, as do our literature reviews when creating label cautions and interactions statements. Many of the negative reports have been questioned because of issues with their study designs or making overbroad or inappropriate conclusions. | |
| The dietary supplement industry fights all regulations. | Dietary supplement trade associations and manufacturers have consistently supported reasonable new laws and regulations that protect the public while avoiding unnecessary regulation. The industry has repeatedly supported bills to add funding for increased FDA enforcement of current laws. | NOW supported the new regulations to implement DSHEA (labeling rules, testing and manufacturing rules, new ingredient notification), as well as more recent laws requiring facility registration and import pre-notification, the banning of steroid precursors, and mandatory adverse event reporting. We have repeatedly promoted bills to fully fund FDA's enforcement activities. | |
| The dietary supplement industry doesn't regulate itself. | Industry trade associations have supported third-party Good Manufacturing Practices auditing entities, enforced standards of conduct, and offered education for their members in areas of regulation and compliance. | NOW has a third-party certifier auditing our Good Manufacturing Practices, follows trade association standards of conduct, and participates in educational opportunities in areas of regulation and compliance. NOW is recognized as a responsible manufacturer and marketer of natural products. |
*The United States Food and Drug Administration defines an adverse event as any undesirable experience associated with the use of a medical product in a patient.
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