Why the Cost of Herbal Supplements Will Skyrocket This Year

IN 2007, the FDA passed a law called the," Good Manufacturing Practices" law. The intent of this law is to stop adulterated products, mislabeled supplements and poor quality products sold in the marketplace to consumers. It is one of the reasons why people say herbs don't work. They were taking a poor quality brand of herb or vitamin supplement. Do you really think that a $4.00 fish oil product has been tested for heavy metals, mercury, and other toxins. This needed testing that is done by quality companies like Nordic costs the company a lot of money. This raises the cost of the supplement but is absolutely necessary. Often, the stated percentage of active oils is herbal supplements is found lacking when tested by independent labs. In fact, the majority of brands fail testing according to their stated label ingredients. This is why the law had to be enacted. Companies were simply not being ethical in their manufacture process. Who does this hurt? It hurts the consumer who cannot tell a good brand from a poor quality brand. Consumers often buy on price and a cheap supplement may have deleted a few quality control steps to give you that price.

Full GMP Compliance Must Be Instituted This Year:

It is a law to make quality assurance mandatory. The rule applies to all domestic and foreign companies that manufacture, package, label, distribute, or hold dietary supplements distributed in the United States. The law has come into effect in 3 stages. They started with the large companies with over 500 employees first. This was to give the small mom and pop companies more time to make the changes required. Small companies with more than 20 employees but less than 500 had to be compliant by June of last year. The smallest companies who have less than 20 employees have to comply by June of this year. This rule impacts every herb and supplement company in the US. The FDA have been behind in its inspections, so many companies have not been inspected at this time. It may be the end of the year before all the company inspections are finished. If you do not comply, you must quit your business. End of story.

How Will GMP Effect The Manufacture of Herbal Supplements? The rules for compliance include having qualified staff members employed at all times: having your plant or area of operation designed to protect against product adulteration; having the proper machinery and utensils; instituting the use of master manufacturing and bath production records; using quality control procedures; holding and distributing the herbs, supplement material, and finished product in a way that quality is maintained; and recording each products -related complaints for 1 to 2 years. Many companies are protesting these rules because the language is vague on how these rules should be implemented. How do you comply without detailed instructions on what they want done and how? Often, they are not sure until the inspector shows up and writes them up for problems. Each time the inspector comes out, it requires the company to spend money to correct that problem.

Why Will Some Supplement Brands Disappear or Cost More Money? It will cost big companies from $70,000 dollars to $90,000 a year for the compliance. It will cost small companies more than $50,000 a year to comply. There are thousands of small herb businesses that don't make $50.000 from their businesses now. They run their small, part time business from home. They too must comply. Many of these companies do not make enough money to spend the $50,000 per year to comply with GMP regulations.

FDA inspections will be completed by the end of this year. These small companies will get a written notice of where their company failed to comply with the GMP regulations. They will be given a date to bring their company into compliance. When that happens, many of these small companies will close up shop. It will also cause the cost of supplements to go up. When companies have to spend $70,000 and upward to comply with the new FDA regulations, they will raise the cost of their products. They won't have a choice to keep a profit. So by the end of this year, look forward to your supplements costing you more money. The law will weed out unethical companies that sell inferior supplements and products. The law will make the manufacture and quality of supplements more dependable. Along with the good, it will also close down thousands of small companies. That is a great loss to the economy of the people involved and the industry itself. This country was founded on small, family run businesses. The enforcement of regulations has resulted in an economy where only the big guys can stay in business. Now even the big guys, are going under. I am saddened by the path this country is taking in so many areas of our life. The herb supplement industry is just one of many being affected. We need to take more action as a individual to preserve the important foundations of our country. One of those is the right to buy herbs and vitamins.

References:

HerbalGram, Issue 84, Nov 2009, pages 66-67

www.gmp1st.com/gmp.htm

www.standardprocess.com/display/qualitypractices.spi