Managing supply chain adulteration risks with the BAPP Best Practices SOP

For many centuries in the mountains of Tibet, at elevations ranging from 12,000 to 15,000 feet, farmers have harvested cordyceps (Ophiocordyceps sinensis), locally known as yartsa gunbu, a highly prized medicinal mushroom. The fungus infects moth caterpillars from which the fruiting body grows. Upon harvest, farmers are paid based upon gross weight of the fruiting body and the dead caterpillars, with intact fungus-caterpillar pieces being much more valuable than broken-down material.

For financial gain, in rare instances, the caterpillar fungus was allegedly soaked in mineral solutions such as concentrated lead or aluminum sulfate to increase the weight. Literature reports also suggest that in some cases the weight was increased by inserting lead solder into cordyceps. Consequently, and perhaps not surprisingly, reports of two cases of lead poisoning associated with cordyceps were published in a peer-reviewed medical journal.

This is a clear example of “economically motivated adulteration” (EMA), a type of fraud commonly reported in global commerce. Sadly, supply chain fraud, including EMA as defined by the U.S. Food and Drug Administration (FDA), is ubiquitous. Food products such as plant-based proteins, spices and flavoring extracts, grains, oils, fats, honey and dairy products all have examples of known EMA culled from reports dating back to the 1980s.

Under the law (Subpart C, Section 117.130(b)) of the food current good manufacturing practices (cGMPs), food and dietary supplement product manufacturers are required to perform and document a hazard analysis that must include biological hazards, chemical hazards, physical hazards, hazards that occur naturally, hazards that may be unintentionally introduced, and hazards that may be intentionally introduced for purposes of economic gain (aka EMA).

FDA requires each dietary supplement manufacturer to define the specifications and testing methods needed to assure that the finished product meets all standards for identity, strength, purity, composition and limits on contaminants. Companies that manufacture dietary supplements are inspected for compliance by the regulators on a regular basis. Since the beginning of FDA cGMP audits, among the most frequently found deficiencies as reported by FDA are the absence of “adequate specifications” for finished products and the lack of tests to verify the established specifications.

While there are many responsible members in the U.S. dietary supplement industry, ample public evidence reminds us that there are some irresponsible companies that are not cGMP compliant with even the most basic requirements concerning ingredient specifications and analytical methods to assure identity and freedom from adulteration. In particular, some analytical laboratory tests for identity often lack the specificity to clearly distinguish between authentic and adulterated ingredients. Criminals know this and take advantage by developing adulteration schemes that are very difficult to detect by routine analytical testing. Consequently, a manufacturer must be aware of adulteration issues and continuously monitor the global supply chain for fraud and adulteration trends at the ingredient/country level. Once a threat is noticed, the purchasing specification may need to be modified, per cGMPs and 21 CFR 117, and analytical test methods must adapt to better guard against the threat of purchasing adulterated ingredients.

Enter the BAPP Best Practices SOP

The ABC (American Botanical Council)-AHP (American Herbal Pharmacopoeia)-NCNPR (National Center for Natural Products Research at the University of Mississippi) Botanical Adulterants Prevention Program (BAPP), founded in 2011, is an international consortium of nonprofit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants.

BAPP advises industry, researchers, health professionals, government agencies, the media and the public about the various challenges related to authentication of botanical ingredients and how to avoid purchasing adulterated and fraudulent botanical ingredients sold in international commerce. To date, BAPP has published 90 free-access peer-reviewed documents with overall more than 200 U.S. and international parties that have financially supported or otherwise endorsed BAPP.

In response to a global supply chain problem — namely concerns of adulterated ingredients sometimes being returned to suppliers, only to be resold into commerce — BAPP focused on crafting a solution. The result, the voluntary, flexible and carefully crafted “BAPP Best Practices SOP for the Disposal/Destruction of Irreparably Defective Articles,” was introduced in October 2022. The BAPP Best Practices SOP creates a new regulatory term: “Irreparably Defective Articles” (IDAs). It stipulates that when buyer and supplier agree — through appropriate third-party analytical lab testing — that an article is irreparably defective and cannot be lawfully remediated for its intended human or animal use anywhere, it will be destroyed.

Unlike BAPP’s original (and continuing) focus on the economically motivated adulteration of botanicals (which evidence indicates rarely presents a safety risk), the scope of the BAPP SOP applies to all forms of adulteration and food fraud, but also contaminations found in ingredients, components and products intended for human and/or animal use, which sometimes might represent a significant safety risk. These materials include articles that are irreparably defective due to reasons other than EMA, such as accidental chemical contamination, biological contamination, intentional “spiking” with undeclared prescription drugs, and other potentially harmful forms of fraud found in foods, dietary supplements, dietary ingredients, over-the-counter drugs and cosmetics.

This essential work product is provided at no charge to all global stakeholders to help them guard against fraud; in so doing, companies protect their customers, their brand and the reputation of the herb, dietary supplement and natural products industry. The SOP also reduces the risk of expensive regulatory actions that typically require legal counsel, such as warning letters received for adulteration, misbranding and violation of cGMPs, or costly ingredient and product recalls. BAPP also serves as an expert technical partner to help companies create better specifications to detect the everchanging variety of adulteration strategies.

Recalls are very expensive. Those who have participated in a product recall know this all too well. In addition to direct legal and compliance costs, the bad press damages brand reputation and decreases consumer confidence. In the worst cases, consumers are harmed, supply contracts are impaired, and legal action by the plaintiffs’ bar — up to and including class actions seeking damages — may follow.

In the highly regulated natural products industry, FDA (and international counterparts) defines what ingredients and products are lawful for use in dietary supplements, OTC drugs, cosmetics and foods. Detailed cGMPs define the regulations to which industry is held accountable. FDA, along with international counterparts and various compendia, provides seemingly endless guidance concerning adulteration, limits on contaminants, defect action levels, mandatory documentation and the like.

However, while the regulations define what can and cannot be used in all consumer products, they are silent on how a buyer should manage the occasional adulterated and other “non-conforming” products upon receipt from their supplier. In many cases, non-conforming products can be lawfully remediated; in other cases, they cannot.

The BAPP Best Practices SOP, in contractually connecting the dots between regulatory law and contract law, empowers supply chain trading partners to reduce brand and industry risks by removing irreparably defective articles from global commerce.

Growing support and endorsement of the BAPP SOP

We encourage industry members involved in growing, sourcing, purchasing, distribution, production and sales of foods, supplements, personal care and OTC drugs, to read, formally endorse and financially support the expansion and implementation of the BAPP SOP across the global supply chain for all ingredients, components and products intended for human and/or animal use.

In an industry trade publication article, David Trosin, managing director of NSF International’s Health Sciences Certification Program, described how the BAPP SOP protects consumers, adding that “NSF is reviewing the BAPP SOP for possible inclusion in our standards and is strongly encouraging our clients to begin using it.” (Nutraceuticals World, July 6, 2023).

Also, in July 2023, the BAPP Best Practices SOP received the NutraIngredients-USA “Industry Initiative of the Year” award.

The BAPP SOP has been endorsed by various integrative and natural medicine associations and some leading industry trade associations, including the Council for Responsible Nutrition, United Natural Products Alliance and British Herbal Medical Association.

Many leading quality-focused dietary supplement and food manufacturers, contract manufacturers, contract analytical laboratories and expert technical service providers have formally endorsed BAPP and the SOP. We encourage others to join these responsible companies and organizations and participate in our combined efforts to remove irreparably defective articles from commerce.

In July, Informa Markets amended its SupplySide Compliance Program to include the BAPP SOP, recommending exhibitors and attendees adopt BAPP. Informa has been an endorser and financial supporter of BAPP since it first began.

The BAPP SOP is the subject of a SupplySide Stage presentation at this year’s SupplySide West & Food Ingredients North America show, on Thursday, Oct. 31, from 11:15-11:45 a.m. The session is free to anyone attending the show. The BAPP team will also be available for implementation consultations on Oct. 31 at the show. Interested parties can contact Anna Jackson at ABC via [email protected] to reserve a meeting.

Editor’s note: Next up in this three-part series: Global fraud is big business, but enforcement is not: Quantifying the risks and costs of adulteration and the ROI of the BAPP SOP.