Were you or your company active in the botanical industry when “organic” was officially defined by the USDA? Do you remember when the requirements to use the designation “organic” were officially rolled out in the 1990s? If you remember, it was a complicated process that required a long-term view.
At the time, many said the standards advocated by the Organic Trade Association were unattainable, too complicated, and would be too costly. Fast forward 30 years to now –– from farm to store shelves –– there are a massive number of certified organic products in the marketplace because consumer demand is so high for them.
But how does the international supply chain fit in, when regulations developed for US farmers may not translate well or easily?
As a main supplier of Traditional Chinese Medicine herbs to the US market, we have experience in how the term organic is viewed in other countries and how it affects the herbs and botanicals that come into the US from overseas. We want to clarify the process of sourcing and importing organic herbs from one of the main origins of ingredients used by the US dietary supplements industry, China.
The USDA and FDA Regulate Herbs and Botanicals
Many consumers and some medical professionals are under the impression that the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA) don’t regulate or have classifications for botanicals. That’s inaccurate, they are actually highly regulated. So in recent years, we’ve offered education to our practitioner audience so they can better inform their patients. In the US, the USDA regulates all organic agricultural products to a defined set of standards, with a handful of well-established third-party certification programs in place to confirm the legitimacy of a grower or manufacturer’s practices.
All National Organic Program (NOP) certified organic products (herbs to supplements to foods) must all conform to NOP growing and handling standards and be certified by an authorized certifier. Imported organic products must be certified as meeting the USDA organic regulations. The FDA regulates herbs as a special class of foods, rather than pharmaceuticals, for good reason given the long history of safe use and the very low number of adverse event reports. Among the regulatory requirements mandated by law, the FDA requires that herb manufacturers:
- Demonstrate that the herbs have been tested to confirm the identity of the plant, and that the correct plant part is present.
- Ensure that their supplements are free of contaminants and that they're accurately labeled.
- Have research on hand to support claims that a product addresses a nutrient deficiency or supports the structure or function of the body, and include a disclaimer that the FDA hasn't evaluated the claim.
- Avoid making specific medical claims. For example, a company can't say: "This herb reduces the frequency of urination due to an enlarged prostate." The FDA can and does take action against companies that make false, misleading, or unsupported claims to sell their supplements.
All Herbs and Botanicals Imported From China Must Meet USDA and FDA Regulations
One of the key challenges in sourcing organic herbs from China is ensuring that the material meets the certification requirements of the country for which it is intended. Many growers have relatively small farms, so the surrounding agricultural practices need to be harmonious. We spend a lot of time educating our partners, particularly as to what the NOP organics standards they need to meet for the US market are versus other organic standards, and that “organic” doesn’t mean the same thing universally.
The standards are specific to the system that you are being certified to, so growers and processors have to be well-versed in organic requirements and how they vary from country to country. Growers and processors need to pay attention to whether it’s NOP organic or EU organic, for example, that they are producing to satisfy.
The challenges in providing organic herbs grown in China are similar to the rest of the world in that the farmer is trying to grow the plants in a healthy, sustainable manner in an increasingly contaminated world. There have been a few well-publicized episodes that have left the impression with some that products from China are adulterated or contaminated, but the truth is you can find some of the best ingredients in the world there.
Our Chineses Herbs in Meet EU and US Organic Certification Requirements
Because our partners are growing herbs for use specifically for the supplement and functional food industry and we know what the quality expectations are going to be, we do a lot more testing of the herbs than you would do for products grown in the US, from identity to purity. And I think you have to for botanicals imported from overseas, given that there are a lot of vulnerabilities in the global supply chain.
Whether organic or conventional, most companies that buy herbs are getting powders and extracts rather than fresh herbs, so you can’t confirm the identity of the material without some type of chemical testing. We developed an identity system that is one of the most robust in the industry, because just testing herbs when they arrive at a manufacturers production facility is not enough.
Testing and Manufacturing Practices Designed to Guarantee Quality and Purity
We think it makes a difference to inspect the herb both organoleptically and at a macroscopic level to confirm the identity. Other identification methods such as chemical assays, UPLC, HPTLC, and TLC follow to further confirm identity and potency as well as testing for pesticides and heavy metals. We process that harvested herb into powder, extract, tea bag cut, or dried herb, but there are other, more customized processing options we provide that can also meet organic certification.
For example, the Nuherbs Bespoke Extracts, which use organic and/or lab-tested herbs to manufacture a simple ratio extract in the US, customers choose the strength (the ratio), the solvent, and carrier they wish to use. These are extracted in the US, using our herbs imported from China. In 2019, we began offering standardized extracts (chemical markers) that can be super tailored as well, using the type of solvents, carriers, etc. specified by the customer to produce something that is fit for their specific needs, including organic certification.
You Shouldn’t Be Afraid of Sourcing Herbs From China
While China often gets a bad rap in the media, the country and its producers are critically important to delivering organic herbs and other nutraceutical ingredients used by wellness and supplement companies. To successfully produce and sell a finished product containing herbs from China that can be labeled organic, extra care, knowledge, and experience are required beyond the already complex approach to working with a global supply chain.
If you want to have a deeper conversation about China, organic herbs, or your supply chain, send me an email, I’d love to speak with you.
Wilson Lau, Vice President, Nuherbs