What You Need to Know and be Aware of When Purchasing Herbal Tinctures
Bob Burdekin, AES, CHHP
Since almost the beginning of time people all over the world have been able to use herbs to address many different health issues. In fact, the oldest recorded use of herbs dates back to Ancient Egyptian records, close to 3,500 years ago and is contained within the “Ebers Papyrus”. This document lists over 700 medicinal herbs along with specific uses for noted diseases and maladies. In addition to the use by the Egyptians, the Chinese, Native Americans, and many indigenous tribes located within Central and South America have used and continue to this very day to use herbs on a daily basis.
It has been estimated by the World Health Organization that close to 80% of the world’s population rely upon herbal-based supplements as their primary source of health care. It is also a known fact that many of the pharmaceutical drugs that are used extensively and throughout the entire world are all based upon the use of plants (herbal-based); giving additional credence that herbal products do provide positive health benefits while maintaining a remarkable safety profile.
Regulation of Herbal Supplements in the United States
It is the Food and Drug Administration (FDA) as well as its predecessor agencies that has had total control and jurisdiction over all herbal products that are manufactured and marketed within the United States for over 100 years. Throughout this time many herbs were included and categorized as conventional foods and some as drugs, depending upon the classification given to them by the FDA. There are also a broad range of herbs that have a long history being used for their therapeutic value as well as to maintain and promote a more natural health protocol. Although these same herbs were sold for many years there was no set in stone classification for these specific products.
It was the action of the US Congress in 1994 that the passage of the “Dietary Supplement Health and Education Act” (DSHEA) that lead to the clarification and specific regulation by which vitamins, minerals, herbs, and specialty supplements are now allowed to be marketed within the United Sates as dietary supplements.
The passage of the DSHEA that did clarify and properly define how herbal and other dietary supplements are to be regulated, much in the same way that food is regulated by the FDA. This control covers manufacturing processes, labeling, and also allows for seizure and detainment of herbal and supplement products that have been adulterated or misbranded. It is also the duty of the FDA, under the DSHEA, to forbid the sale of any dietary supplement that they determine to misrepresent or present a reasonable or unreasonable risk to the public.
Manufacturers are also required to notify the FDA if there are any “new” dietary ingredients that they intend to add or remove in any of the approved products.
This law also defines the responsibilities of the manufacturers and marketers of dietary supplements; stating each and every ingredient making up the finished product and include the quantity of each ingredient, this also applies to proprietary blends. Any and all claims that are made on the product’s label or packaging are tightly controlled, need to be substantiated, and must not claim to diagnose, treat, cure, or prevent any disease (even if there is evidence to support such a “drug claim”).
The facilities in which herbal and other dietary supplements are manufactured are to be held to the same high standards as any other manufacturing facility that produces conventional food products and in many cases where supplements are created there have been stricter guidelines adopted by both the FDA and industry organizations.
Just as in any industry companies that manufacturer and market herbal supplements have a responsibility to listen to and conform to the legislation of other federal agencies, not to mention that of state and local regulations as well. As an example, the Federal Trade Commission enforces the guidelines that regulate advertising of all consumer goods, and herbal supplements also fall within that series of guidelines. There is also the inclusion of the fact that marketers of organic herbal product have to be familiar with the rules that are controlled by the US Department of Agriculture; continuing to understand that manufacturers of herbal extracts need to be in compliance with legal guidelines set by the Tax and Trade Bureau.
One last point on this topic of regulation compliance starts out with the Department of Transportation and how their rules apply to the interstate transportation of the finished product. That then leads us on to the US Customs and Boarder protection that governs anything and everything that comes into or goes out of this country. Lastly I will mention the Occupational Safety and Health Administration that protects all workers in all areas.
The manufacturers of herbal supplements are subject to extensive federal laws and regulation by many different agencies'; each of these federal agencies are responsible for enforcing specific rules that will guarantee that the needs and safety of the consumer are properly met, and that companies that do not follow the rules do not have the opportunity to gain unfair advantage over the companies that do follow the rules.
These laws, that are currently in effect, have been designed to ensure that safe and beneficial dietary supplements, including herbal products, are available to well-informed consumers that will give them the correct information to be able to make proper and decisive decisions about their own self-care choices.
It is a responsible manufacturer and marketer who continues to provide this quality of a product so that the consumer will continue to enjoy the health choice freedoms which they demand and deserve.
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