Feature Article: What's Happening to Ensure Your Supplements Are Safe
 Natural health is a hot topic these days, with more news articles, television feature spots and research dollars being allocated to this booming category. With this increased attention on natural health and its potential role in our health care system, some companies are getting into the act to cash in on the desire of consumers to live a healthier life. While most of the companies out there do make quality products, this kind of attention also brings those who are looking to make a quick buck on the consumer attention to this category. This brings the question "What's going on to ensure that supplements are safe?" What follows here is a summary of the new laws in place to make sure consumers are getting what they expect to get and a few pargraphs to let you know what organizations are looking out for you in this regard.
There are currently three groups that are most involved in making sure your supplements are safe, including the FDA (the Food & Drug Administration), the FTC (the Federal Trade Commision) and the NPA (Natural Products Association). The NPA is an industry organization that has been around for over 70 years working on ensuring only the highest standards in the industry, providing education for its members, making sure consumers continue to have access to dietary supplements, and generally promoting the health of the public through its initiatives. The group is supported by dues from industry members including retailers like Walsh and also manufacturers and distributors of natural products. It is an organization that, from my experinece with them, has a tremendous purity of purpose and is very active and effective in what it does for consumers and industry companies alike.
Back in 1994, DSHEA (the Dietary Supplements and Health Education Act) was made law, giving the FDA jusrisdiction over dietary supplements. Although the FDA does not require pre-market approval of dietary supplements, this law did allow the FDA jurisdiction over supplements, which comes particularly in the form of requiring accurate labeling. So when you hear that dietary supplements are unregulated, this is simply not true. As a part of the act, "good manufacturing practices" (GMP) were to be defined. It hasn't happened until now that this has actually been accomplished. The FDA recently issued its final 815-page GMP ruling which it says will prevent supplements from containing the wrong type or amount of ingredients, and will prevent contamination by substances such as bacteria, pesticides, glass and heavy metals. It includes requirements for quality control procedures, designing and constructing manufacturing plants, and perhaps most importantly, testing ingredients and finished products. It also includes requirements for recordkeeping and handling customer complaints.
The NPA was very active in the GMP rule standard process, and gave comments throughout the process to help the FDA make a strong rule that is reasonable for manufacturers to comply with. Companies with 500 or more employees must comply by June of 2008, those with fewer than 500 will have until June of 2009, and very small companies with less than 20 employees will have until June of 2010. The NPA has been providing seminars, webcasts and other education to its members over the last two years to prepare them for this important change, so the good news is that many companies are already well on their way to complying. This includes many of the companies whose products we carry. If we buy a product from an upstart or small company, we will be sure to find out their level of complaince with the new standards before bringing their products in.
It is also important to note that while the FDA is currently understaffed and does not have adequate funding according to many industry experts, that a bill has passed the House that will allow for $90.7 billion in additional funding to help solve this problem. The bill still has to pass the Senate and be signed by the President to become law, but is an important step in improving regulation.
December 27th of this year will mark the effective date for the "Dietary Supplement and Non-Prescription Drug Consumer Protection Act". The Act requires manufacturers, packers and distributors of dietary supplements AND certain over the counter (OTC) drugs to notify the FDA of all serious and adverse events reported by customers. The NPA was instrumental in making sure that the Act included not just natural products, but also required OTC drugs to report these events as well. This will allow the FDA to monitor potential problems with supplements and OTC drugs, giving additional protection to consumers. The event must be "adverse", which is defined in the law as:
- an event occuring from an overdose (intentional or otherwise)
- an event occuring from drug abuse
- an event occuring from drug withdrawal
- an event arising from any failure of the expected action of the product
To be considered "serious", the event must result in death, a life-threatening experience, in-patient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or requires surgical intervention to prevent any of these events. The Act requires labels of products covered under the law to contain a phone number that customers can use to report these events. While retailers are not responsible for reporting these events, we would certainly like to know if you have reported such an event so that we may be aware and act accordingly.
The FTC provides protection to consumers primarily by preventing false label claims. I saw a representative of the FTC speak at the Natural Products Expo East recently and was surprised to learn that the FTC spends about 60%-70% of its time evaluating and acting on claims made by health-related products. The FTC looks at many things regarding label claims incuding express and implied meanings, the net impression the consumer takes away, testimonials, substantiation of claims, taking into account all of the available research, and making sure the company doesn't overstate the benefit and discloses material information. In 2006 & 2007 the FTC was successful in its cases against several companies selling weight loss supplements. When it discovers a category where there seems to be misrepresentation, it will do a sweep of the internet to find companies that may be making false claims. They will send out a warning letter to which most companies respond and then try to get into compliance. The penalties for non-compliance are severe and have sometimes involved entire companies going out of business to satisfy the monetary retribution owed to customers. The weight loss supplements against which the FDA successfully brought cases were Xenadrine EFX, Cortislim, Trim Spa and One A Day Weight Smart.
The Natural Products Association Foundation, the arm of the NPA that advances public health through research and education about dietary supplements, nutrition and related products, has recently announced two new initiatives important to increasing consumer confidence in the naturals industry. The first is the Finished Products Test Program. The group will randomly select 15 popular consumer products each month ranging from vitamins and minerals to nutrition bars and sports beverages to determine that what is on the label is actually in the prodcut. All results will be published on the Foundation's website. This initiative sends the message that the inductry will not tolerate dishonest products on store shelves. Companies will have the chance to respond and make modifications, but results will be reported as they are found.
The second initiative is the Truth in Advertising Program. This program will help members comply with mandates set by the FDA and the FTC. Most companies don't willfully flout the rules and the NPA foundation will help them make sure they understand and convey appropriate messages to consumers. A hotline will be established whereby consumers, retailers or competitors can report claims they believe are fradulent and Foundation officials will review these claims and determine if action is necessary. The theme of both of these new programs, according to David Taylor, the NPA's President, is about increasing trust between consumers, the industry and the governement. "We've developed a trust level on Capitol Hill that as an association we haven't had in 70 years," he said.
So...rest assured that the industry itself as well as the government are working together to keep your supplements safe and efffective. With the combined efforts of these groups, consumers will be able to gain the confidence they need to take control of their health by using proper nutrition, using effective supplements, and preventing disease rather than dealing with the challenges and aftermath of it!
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