FDA Warning Letters for Dietary Supplements Database Made Available to Public
Recently, the Council for Responsible Nutrition (CRN) released a comprehensive online resource for consumers. This resource, allows the public to quickly and easily access FDA Warning Letters that have been sent out to dietary supplement companies in violation of regulations set forth by the FDA (http://www.crnusa.org/FDAWLDB/form.html). While the FDA is an agency within the United States Department of Health & Human Services, the dietary supplements regulated by them are marketed globally. The implications run beyond all borders, and thus this new CRN driven online tool is of great value to invested and concerned consumers from all over the world.
The CRN is a prominent trade association that represents manufacturers and suppliers of dietary supplements and functional foods. Like the FDA, the CRN is based in the U.S. but theoretically helps set the tone for regulatory compliance of dietary supplements on a more global scale. These supplements, are directly relevant to consumers, considering the fact that the brands addressed by the CRN are found in local and national grocery stores, pharmacies, natural food retailers, and other sources where consumers can order items online. The mainstream nature of these natural products has created the necessity of organizations such as the CRN. To date, they represent over one-hundred manufacturers and suppliers, ensuring that members comply with quality control regulations and relevant ethical checks and balances. The new CRN tool providing access to related FDA Warning Letters puts a much needed public face on these manufacturers/suppliers, and their products. Read further to learn more about this database, including an answer to the question – is it enough?
What Consumers, Manufacturers, and Suppliers Need to Know About the CRN Tool for Dietary Supplements
Open Access to FDA Warning Letters Regarding Company, Product Name & Ingredients
Accessing the database is easy. Beginning here, you only need to enter some basic information including name, company or consumer status, and an email address. Once completed, you are taken directly to the database search tool. From there, you are given the option to search a dateline of categories that include everything from company name, product name, ingredients, and the option to select whether or not the company has written a response letter. You may be curious about an energy drink that your college student consumes heavily during exams or an essential oil promoting vitality in seniors. Either way, this tool will be of interest to you. Within a minute, an inquiring consumer is able to find out whether or not any of the dietary supplements relevant to their household have been cited by the FDA over the last decade. The following screenshot details what you, the user, will see:
Database Search in Action
If there are FDA warning letters matching any combination of the chosen filters, they will be presented. At that point you can click through to view the FDA’s comments. Of course, more details regarding the warnings are made available, as is access to company response letters should there be any rebuttals or acts of atonement. In the end, users are simply given as much information as possible so that they can come to a more qualified conclusion when investigating nutritional supplements relevant to them.
Is it Enough?
Pundits praise the CRN for the release of this valuable tool. It’s a step in the right direction towards keeping dietary supplement companies accountable for any and all product claims. However, considering that the health of the public consumer is at stake, there is always room for quality control checks for supplement purity, potency, and integrity. In this regard, the not-for-profit organization ISURA has been established to work with manufacturers, distributors and retailers within the natural health industry. ISURA’s mandate is to provide a certification program that includes the testing of natural health products for contaminants, such as pesticides, residual solvents, heavy metals, and alpha toxins. In addition, ISURA provides non-GMO certification of products, and potency testing. The underlying goal of ISURA is to provide the natural health product industry with a mechanism for self-regulation that protects the consumer and the health of the industry.
To learn more about ISURA’s certification, education, and advocacy programs we encourage you to contact us today. Until then, stay tuned as we continue to report on the checks and balances of this essential industry.
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