It’s time to go back to the beginning, all the way to the raw materials. First, there’s the all-consuming issue of tariffs, of what happened, how the industry fought back, and what to do now that the tariffs have passed. From there, we move on to how manufacturers offer all-important transparency, how technology is helping them do it, and the certifications to look for when research fails you. Labeling issues keep popping up, so we’ll go into why your products are—or aren’t—marked the way they are. And then experts will talk about what kind of innovation they see in the near future.

Tariffs and TradeThe basis of today’s Trade Action is the Trade Act of 1974, which was passed to help industry in the USA become more competitive or phase workers into other industries or occupations. It gave the President the authority to counteract injurious or unfair trade practices. Section 301 states that the President must determine whether the current trade practices are unjustifiable, unreasonable, or discriminatory, or that they burden or restrict U.S. commerce before he can enact trade policy (1).

The first two lists of tariffs indirectly hit the natural products industry. The USA placed tariffs on machinery and parts that specifically target farming machinery, dairy machinery, and machines for cleaning, sorting, or grading eggs and other agricultural produce, to sum up and condense a long list of products (2). Should farmers choose to buy these finished products from American companies, they’ll find that tariffs have been placed on metals from China, too, so supply chains that exist on American soil might have just as hard a time as those that do not (3).

Once the materials make it to a manufacturer, they’ll hit more roadblocks. “We will see the impact on the import of machines and equipment,” says Luis Echeverria, president of Evi Corporation, Medley, FL. “We recently imported instruments from China that arrived early September, and the new tariffs of 25% had already been imposed.”

The view isn’t too nice if we look past machinery, either. The American Herbal Products Association (AHPA) and the Natural Products Association (NPA) both released lists of products on the third list of tariffs that affect their members, and submitted statements requesting these items to be removed. The two lists include dried herbs, vegetables, and fruits; seeds, a variety of calcium compounds, packaging materials, fatty acids, amino acids, lecithins, sugars, coloring matter, essential oils, perfumes, and makeup (4, 5). The only items that were removed from the final tariff list were glucosamine and sucralose.

AHPA wrote that their request is grounded in the Congressional Statement of Purpose that accompanies the Trade Act of 1974, which states that the Trade Act is specifically to foster the economic growth of and employment in the United States. Regardless of fairness in terms of trade or intellectual property, they pointed out, “for many ingredients China is the primary or only source” (4).

Daniel Fabricant, CEO and president of the NPA, agreed there is no way to domesticize this industry. “China is the only country which can handle ingredient sourcing on the scale demanded by finished product manufacturers in the U.S.,” he said, adding that “these tariffs are simply unsustainable and unaffordable for these small businesses, since China is the single largest global supplier of safe, reliable, and cost-effective raw materials” (5). AHPA went into greater detail, using the example of eleuthero root. The root used to be available from multiple countries, but suppliers in most countries discontinued production of the crop as prices dropped. Should new suppliers be willing to cultivate the crop anew, it will be years before the roots are ready to harvest. Given that dietary supplements often rely on roots, bark, leaves, flowers, fruit, and so on, starting with a whole new crop would mean waiting anywhere from three years to a decade to reach the point at which the crops could be used commercially (4).

Compound that with the fact that farmers would need financing, and that smaller manufacturers can’t afford to finance them, and the concept of starting over goes from a molehill to a mountain. Add onto that the need to regulate materials, the need to verify that these new suppliers are complying with regulations, and the need to re-evaluate the quality, sustainability, and regulatory compliance of the suppliers and the supply, and instead of forcing China to crack down on intellectual property theft, the natural products industry is just forced to pay China more (4).

Furthermore, according to the New York Times, moving even just the manufacturing out of China isn’t practical. In Cambodia, there are water buffalo that cause traffic jams. China has “reliable roads and rail lines connecting suppliers to assembly plants to ports,” where Vietnam and Cambodia do not. And if pieces of a final product have to be made in China and then shipped to another country, delays can mount and cost money that smaller companies don’t have (6).

Fabricant and AHPA worry that the industry as we know it won’t survive that kind of interference, let alone achieve its projected growth. AHPA writes that the dietary supplement industry accounted for roughly .68% of the U.S. GDP and employed 383,230 Americans in 2016, and Fabricant pointed out that industry analysts project a 10% compound annual growth rate over the next ten years (4, 5). That said, it isn’t made up of large companies that can take the financial hit in order to maintain business until the President resolves this issue. It’s made up of small businesses. As Fabricant wrote in his request to testify, “if small- and medium-sized companies were forced to obtain dietary ingredients from alternative sources, most small- and some medium-sized companies would be out of business” (5).

As of Sept. 24, those tariffs went into effect. They’re starting out at 10%, but if China does not make the concessions Trump is looking for, they will jump to 25% at the end of the year (7). In his announcement, Trump threatened to add taxes on an additional $267 billion worth of imports should China retaliate. On Sept. 18, just hours after Trump announced those tariffs, China announced tariffs of 5% to 10% on $60 billion worth of U.S. products, which went into effect on Sept. 24 (8).

Now that the tariffs have passed, Fabricant says, it is worth talking to your congressman about an exclusion process. The first two lists had one; the third list, which affects the industry the most, does not. While we should respect the process of trade negotiation—“China is our biggest trading partner,” he said, “we need to get that relationship right”—it’s about balance. The tariffs as they currently stand will hurt us more than they will hurt China.

“It is very difficult to predict how political decisions will trickle down.”

Even those companies that don’t deal with China are worried. “It is very difficult to predict how political decisions will trickle down,” says Nena Dockery, technical services manager at Stratum Nutrition, Carthage, MO, a company that doesn’t source any of its ingredients from China. “It is possible that we might be impacted by retaliatory tariffs on US-produced goods, but that is also unknown at this time.”

Leslie Gallo, VP of operations and sales at Artemis International, Fort Wayne, IN, is alarmed by the possibility that both sides might just impose tariffs on all goods, and the trade war might grow to encompass other countries. “With countries threatening retaliation against our changing trade laws, going forward we might have unfavorable tariff conditions.”

Brian Appell, marketing manager for OmniActive Health Technologies Inc, Morristown, NJ, says the only possible approach is a proactive one. “We will be transparent in any changes that may affect our customers,” he says. “We are a global organization and so these sorts of complexities are not new to us. We are looking for ways to minimize any burdens on our customers while remaining competitive.”

Echeverria says we aren’t alone in this. In his last trip to China, his suppliers noted that they were concerned about a decrease in business. “This will be a game changer in the relationship with China.”

George Pontiakos, president of BI Nutraceuticals, takes a very different view. The current 10% tariff is nothing, he says, and will have no effect on the market. The 25% tax might make consumers pay a little more, but he says that it won’t make much difference; after all, it’s not that trade has been restricted altogether, it’s just “leveling the playing field.” The real problem here, Pontiakos believes, is time—with both countries delaying shipments of items that need to be tested and standardized and used in formulas, the final product takes a longer time to hit the shelves than it did before. “This is both countries posturing,” he says. “China understands and respects a strong hand in negotiation. They’ve been negotiating since Marco Polo, they know what to do.”

Moving away from China, NAFTA has been renegotiated. Now it’s the U.S.-Mexico-Canada Agreement, which was agreed upon on Sept. 30 and is awaiting ratification. Among other things, it grants the U.S. greater access to Canada’s dairy market. The Produce Marketing Association (PMA), the Produce Coalition for NAFTA, and the Canadian Produce Marketing Association have all commended the deal. Richard Owen, VP of global membership and engagement for the PMA, said “this agreement is consistent with our overarching goals of free and fair trade.” There is a built-in end date of 16 years. While on the one hand, that could make investors wary of dealing with something with such a short time limit, Owen thinks otherwise, suggesting it allows all three countries to expand trade and build up the existing agreement (9).

Technology and TransparencyTechnology is streamlining the whole industry with an eye towards increasing transparency and accountability. Vitature is a cloud-based software that organizes everything the industry needs to function, with one section for suppliers, one for manufacturers, and one for retailers. Standardized compliance documentation, automated manual processes, and streamlined communication with clients, along with DSHEA-compliant information about research and ingredients for retailers, can help the whole supply chain move along in an easy and regulated manner (10).

Alternatively, some companies are trying out QR codes. A QR code can be linked to raw material origin information, including information on the country of origin, suppliers, and manufacturers. While it’s currently only available to manufacturers and retailers, it has the potential to be passed off to consumers. While customer service is the best way to keep your business extant, it can’t hurt to have that information available to all customers when they want it (11).

And in the future, your suppliers might be able to prove in front of your face that their product is what they say it is. Cosimo Simone Palumbo, marketing director and general manager of Indena USA, Seattle, WA, says that while most plants can be correctly identified by both a macroscopic and a microscopic analysis, some cases require DNA testing. In the hopes of reducing mistaken identification, Indena signed a cooperation agreement with Hyris and the NHP Research Alliance to jointly develop an app-controlled portable laboratory to allow botanical DNA to be tested in any setting, not just in Indena’s labs.

Even ignoring technology, companies are becoming ever more transparent about their sourcing. Axiom Foods and Evi Corporation have maps with their suppliers pinpointed, so you and your customers know precisely which area of the world their materials come from. Neptune specifies that, out of the 85 different species of krill around the world, it uses Antarctic krill, the harvest of which is controlled by the Commission for the Conservation of Antarctic Marine Living Resources. OmniActive has a vertically integrated operation, allowing it to provide transparency and traceability at every stage in the supply chain. Linnea International mentions its cannabis extract comes from a specific clone of cannabis cultivated in Switzerland under the supervision of Linnea staff.

Some companies get incredibly specific. Horphag sources its Pycnogenol from a forest in southwest France, and its extraction process is patented, meaning the product is traceable back to a single place and the whole process is under their control. HP Ingredients sources its Tongkat Ali from Malaysian rainforests, where only the native Orang Asli people are allowed to harvest it. HP Ingredients also gives back to the communities they partner with, donating computers equipped with native languages and building processing facilities in villages.

It’s worth pointing out that all this information was found on company websites. Suppliers are looking to make source information abundantly clear at a glance. And if all of it fails, there’s always the abundance of certifications to let you know someone who cares about material quality as much as you do has guaranteed the material was processed safely and that the result is of high quality.

Before any other certifications come into play, ingredients must attain Generally Recognized as Safe (GRAS) status. While not without its issues—the FDA doesn’t need to study the material in question—it says that science shows that, in a particular application, a material is not harmful. CV Sciences, creator of PlusCBD Oil, has received self-affirmed GRAS status. CV Sciences is the only hemp CBD nutraceutical company to invest in and provide the necessary scientific evidence to achieve GRAS status, in a continued effort to build and maintain consumer confidence (12). This, by the way, is a good reason to sell branded products instead of generics. Tod Burgess, vice president of sales for Deerland Probiotics and Enzymes, Kennesaw, GA, says “branded ingredients tend to bring much more value than generics. They reflect investments in science, human clinical studies and quality.” A generic might be cheaper, but it’s PlusCBD Oil and DE111 that raise the money necessary for you to confidently sell a product at all.

Once the material is GRAS, there are certifications for the growing process. Dockery finds that “organic certifications and non-GMO certifications are becoming increasingly important for botanicals.” USDA Organic certification ensures that antibiotics, pesticides, and chemical and synthetic hormones and fertilizers don’t enter into the picture, while the Non-GMO Project tests for GMO residue at multiple levels of production. Appell finds that Non-GMO Project Verification is particularly important, as it is North America’s only third-party certification agency for GMOs. Burgess says Deerland chooses to be Non-GMO Project Verified because “our ingredients start out in nature, so we have opted to remain true to nature.”

Once grown, the certifications for a product branch out in all directions, from national to international to religious. According to Dockery, “Halal and Kosher certifications are necessary on almost all ingredients.” Given that most Halal and Kosher requirements address meat, products that are vegan or vegetarian would require minimal work to make them certifiably Halal and Kosher. The extra step of bringing in a reputable agency to verify them as such opens up two entire markets of people who would have otherwise been barred.

The manufacturing process itself can be certified for Good Manufacturing Practices (GMP). Third-party GMP certification is “crucial,” according to Burgess, and Gallo says “proof of GMP as well as strong FSMA compliance are more important than ever before.” Among other things, the examination checks for proper employee training, the purity of raw materials, sanitation, plant design and construction, thus ensuring suppliers are following the best possible manufacturing processes. The FDA relies heavily on reports of illness resulting from a product or of the subpar quality of a product before it conducts an inspection, so having a third party certify a manufacturing plant is a good way to ensure quality never drops that far. On top of that, some programs, like the NPA GMP Certification Program, have higher standards than the FDA.

The final product can also be certified in a manner that takes into account every part of the process, from seed to product. They fall into two categories: those that have been recognized by the Global Food Safety Initiative (GFSI), and those that have not. The GFSI is an international benchmarking service that helps standardize various certification programs, so that food around the world can be held to the same standards. “Facilities certified to GFSI schemes and similar globally recognized certifications help give buyers the assurance that the raw materials are meeting increasingly stringent regulations,” says Gallo.

Safe Quality Food (SQF) and FSSC 22000 are both recognized by the GFSI. SQF verifies food safety and quality, and examines the manufacturing process to help proactively identify risk and to help reduce waste. FSSC 22000 is similar, although it was created to bring another food safety certification, the ISO 22000, up to the standards of the GFSI. Rod Benjamin, the director of research and development at Bergstrom Nutrition, Vancouver, WA, says that FSSC 22000 “not only encompasses prerequisite programs required by Good Manufacturing Practices, it also meets or exceeds the new FSMA requirements.” Bergstrom chose to have their methylsulfonylmethane product, OptiMSM, FSSC 22000 certified, verifying to you and to your customers that their product was held to the highest standards.

For dietary supplements, specifically, there is the Supplement Safety and Compliance Initiative (SSCI), a retailer-led benchmarking program modeled after the GFSI that hopes to create standardized global systems for the certification of dietary supplements. It creates a minimum standard that all manufacturers must meet before being accepted by major retailers. The goal of the program is to increase consumer confidence and trust, and to make it easier to prove to your customers that the industry is regulated. It’s also worth looking past the product itself. Palumbo says Indena has obtained the ISO 14001 and ISO 18001 certifications, which deal with environmental management and occupational health and safety, respectively. “These certifications link environmental management to health and safety issues,” says Palumbo. They verify that a company implements procedures that mitigate risks to people and to the planet. Appell says OmniActive makes a point of sustainability and social stewardship, which he calls a “cornerstone” of its operations and values.

“Certifications have to be considered not a goal, but a starting point for improving processes, technology, and organization.”

The last, and maybe the most important, word on the topic comes from Palumbo. “Anyway,” he says, “certifications have to be considered not a goal, but a starting point for improving processes, technology, and organization.”

LabelingThis year’s regulatory challenges revolve largely around labeling. One of the most newsworthy issues is California’s Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. It’s not new, obviously, but as of Aug. 31, there are new rules in effect. The label is now required to contain a triangular yellow warning symbol and the official Prop 65 website. The full form of the warning requires the manufacturer to state the name of the chemical in question, but the short form, for small labels, strips it down to the warning symbol, website, and type of harm the chemical causes (13).

While this is meant to help the customer make more informed choices, it will most likely be up to you to educate them. The list of harmful chemicals contains aloe vera and aspirin right alongside asbestos and cocaine, making the warning label—especially the short form—less than useful, and desperately in need of human interpretation (14). Things like lead and arsenic are naturally occurring, even in organic fruits and vegetables, and given that the list of chemicals is nearly 900 items long, there will be plenty of products with labels in need of explanation.

In the meantime, keep an eye on litigation revolving around Prop 65. In court, the burden is on manufacturers to prove their own innocence instead of on litigants to prove guilt, and since most companies would rather settle outside of court than pay legal fees and risk a public lawsuit, people are now capable of “legalized blackmail” (15). Settling outside of court also means a company is open to further litigation, which might make it worth it for some to actually go to court, which may make it harder to sell their products.

The industry is fighting back through the Coalition for Accurate Product Labels and the Accurate Labels Act, a bipartisan, bicameral act introduced by Sen. Jerry Moran (R-Kan.) and Reps. Adam Kinzinger (R-Ill.) and Kurt Schrader (D-Ore.). Both the Coalition and the Act are looking to establish science-based, risk-based criteria for warning labels, and are fighting against Prop 65 and laws like it (16). Warnings on products that don’t take science or risk into consideration are not only unlikely to help customers manage risk, they also teach customers that warning labels don’t matter. As Moran said, “our labeling requirements on the federal, state and local levels must be based on credible science so we can provide consumers with accurate, relevant, and critical information pertaining to nutritional facts” (16).

The general public may have found a way into the battle as well, through Prop 65’s most popular victim: coffee. “When we have mandatory cancer warnings on a cup of coffee,” Schrader said, “something has gone seriously wrong” (16). Aaron Carroll wrote an article for the New York Times on coffee and Prop 65 in which he points out how utterly misguided it is. Acrylamide, the chemical that Prop 65 lists as being dangerous in coffee, causes cancer to rats, but only in enormous doses that no human could ever manage to take in. The American Cancer Society, Carroll notes, reports there is no cancer risk for acrylamide intake (17). On June 15, there was a proposal to exempt coffee from Prop 65 warnings, but while the public comment period ended on Aug. 30, there hasn’t yet been any sign of its removal.

Prop 65 is not the only labeling issue the industry is currently tackling. As of this September, the FDA has updated its guidance on the labeling of colony forming units (CFUs) in probiotics—just its guidance, though, not its actual legislation. The guidance states that manufacturers of probiotic products are allowed but not required to declare the live microbial quantity in terms of CFUs in addition to the weight declaration required by regulation (18). Burgess points out that probiotics are not measured by weight at all, making any weight measurement not only irrelevant but misleading. Two brands might have the same weight of probiotics, but wildly different CFUs, so a customer who tries the subpar brand may choose not to try the better brand because according to the label, the amount of probiotics weighs the same in each. Dockery says the fight to remove the weight-based model of declaration is far from over. “These guidelines definitely do not represent the end of the story. Suppliers are continuing to work on more accurate ways of declaring the active micro-organisms in a product.”

And last but not least, while the FDA requires a new dietary ingredient form for synthetic botanical ingredients, it does not require that labels declare a product’s synthetic ingredients. “In many cases of botanical synthetics,” Dockery says, “the efficacy is not equivalent to that of the plant-sourced material.” Again, traceability is important. If your suppliers can show you where their materials come from, this might not be an issue for you. That said, other companies can sell similar products more cheaply if they’re made with subpar ingredients, making it crucial for you to be able to say with certainty that you know the origins of your products.

Advancement“I think the advancement in our industry will come from new and innovative delivery systems,” says Echeverria. “Consumers want to consume their nutritional daily allowance from their regular meals, so new, innovative functional foods will have to revolutionize the way we eat and the way we stay healthy.” For instance, they may gravitate towards chia. As Echeverria says, “chia is the most highly nutritious of all superfood grains.” It has a high concentration of Omega 3 oil, is rich in antioxidants, and contains high amounts of fiber, iron, calcium, and protein. Given that it can be used raw, milled, cooked, as flour, or as oil, this ancient grain might be the future.

Burgess agrees. “Our DE111 is shown to be stable in foods and beverages, unlike traditional probiotics,” he says, which opens up the future of probiotics. That said, he also recommends selling outside the box. “Gummies are appearing on shelves for nearly every supplement ingredient. They’re no longer just for kids.”

Dockery also sees the future in new delivery systems, pointing out the wide range of oils and powders and water-soluble forms that ingredients can take these days. “These new delivery systems greatly expand the opportunities for placing ingredients into a variety of formulations.”

Of course, none of this can happen if manufacturers can’t maintain the bioavailability of their product. OmniActive uses its UltraSOL system, which converts poorly absorbed nutrients to water dispersible ingredients for enhanced bioavailability. “We are always looking for new ingredients to use with our delivery systems in order to provide solutions to complex formulating issues,” says Appell. Indena uses its proprietary Phytosome technology, which, according to Palumbo, is a food grade delivery system that mimics the absorption of a fatty meal while optimizing the absorption of botanicals with low bioavailability. It is also effective and tolerable over a long period of time. He says Phytosome is “the only delivery system in the world entirely made of natural elements,” suggesting the rest of the industry has some catching up to do.

“The technology of retail packaging is still far too wasteful and its impact on the environment far too great.”

And, of course, the industry strives to be ever more natural. Dockery mentions that extracts have been making strides. “There have been substantial advances in extract preparation techniques that use water instead of chemical solvents, yielding a cleaner product.” Gallo hopes to see the same advancement in packaging. “The technology of retail packaging is still far too wasteful and its impact on the environment far too great.” She points out that plastic is ending up in landfills in record amounts, water bottles being among the worst culprits but by no means alone. “We must either figure out a way to recycle plastic without further impacting our environment, or eliminate plastic from our packaging.” Artemis is testing alternative, more environmentally friendly packaging materials, and hopes to eliminate the plastic pails they use by 2019. “We must make advances with packaging, and the companies that do so successfully should be rewarded by consumers.” Natural, she says, shouldn’t end with the product.

References:1. “Trade Act of 1974.” Wikipedia. Accessed 9/17/18. 2. Jethro Mullen, “China: The US has started ‘the biggest trade war’ in history,” CNN, 7/6/18. Accessed 9/17/18. 3. Justina Crabtree, “The full list of US products that China is planning to hit with tariffs,” CNBC, 4/4/18. Accessed 9/17/18. 4. “AHPA requests relief for supplement and herbal industry from tariffs on imports from China,” 9/11/18. Accessed 9/17/18. 5. Daniel Fabricant, “Hearing before the United States trade representative section 301 committee,” 8/20/18. 6. Alexandra Stevenson, “Trump’s Tariffs May Hurt, but Quitting China Is Hard to Do,” New York Times, 9/24/18. Accessed 9/25/18. 7. Avie Schneider, “Trump Sets Tariffs on $200 Billion in Imports from China,” NPR, 9/17/18. Accessed 9/18/18. 8. Antony Kuhn and Avie Schneider, “China Sets Tariffs on $60 Billion In U.S. Goods, Retaliating Against U.S. Duties,” NPR, 9/18/18. Accessed 9/18/18. 9. “Revamped NAFTA “consistent with our overarching goals,” says PMA,” Fresh Fruit Portal, 10/02/18. Accessed 10/05/18. 10. Vitature. Accessed 9/17/18. 11. Tom Dubinski, “Using technology to improve supply chain transparency,” Natural Products Insider, 9/10/18. Accessed 9/11/18. 12. “CV Sciences, Inc. Achieves Industry’s First Hemp Extract GRAS Self-Affirmation,” 9/10/18. Accessed 9/17/18. 13. “What is Proposition 65?” Accessed 9/17/18. 14. “Listed Chemicals.” Accessed 9/17/18. 15. Elaine Watson, “Amended Prop 65 regulations likely to prompt a significant uptick in litigation, predict attorneys,” Food Navigator-USA, 8/31/18. Accessed 9/17/18. 16. “Sen. Moran, Reps. Kinzinger and Schrader Introduce Accurate Labels Act,” 6/7/18. Accessed 9/17/18. 17. Aaron E. Carroll, “California, Coffee and Cancer: One of These Doesn’t Belong,” New York Times, 4/23/18. Accessed 9/17/18. 18. “Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” 9/18. Accessed 9/17/18.