Supplement Ingredient Supply Trends Can Shed Light On Adulteration

The sudden abundance of formerly scarce raw ingredients for dietary supplements may signal economically motivated adulteration.

Products such as hoodia-based weight-loss aids, chondroitin-containing joint support supplements and "superfruit" derivatives are prime targets of EMA that need tighter monitoring, especially where identity testing falls short, industry experts said at a public meeting May 1 in College Park, Md.

FDA conducted the meeting to discuss adulteration of agency-regulated products and strategies for identifying and halting the practice.

The agency is seeking answers to questions about EMA, including what marketing techniques may leave products more vulnerable to adulteration and which analytical methods used by regulators and industry are failing to identify risks (¹ (Also see "FDA Seeks Public Input On Secrets Of Profit-Motivated Adulteration" - Pink Sheet, 2 Mar, 2009.), p. 5).

Shaun Kennedy, director of the University of Minnesota's National Center for Food Protection and Defense, explained that supply chain shifts - for example, a country or firm suddenly producing a particular ingredient far above historical norms - can raise flags and prompt tighter scrutiny of an import.

Regulators can then pair these data "with other information as far as what are the opportunities for doing that adulteration based on global quality assurances," Kennedy said.

Council for Responsible Nutrition executive Andrew Shao agreed that pinpointing opportunities for criminal activity is critical.

Shao also pointed out that even without closely tracking import data, supplement manufacturers and retailers can find red flags by considering a material's background and characteristics when researching its pricing and availability.

Hoodia, an appetite suppressant sourced from an endangered plant indigenous to Africa, is a prime example of a scarce ingredient's supply falling behind consumer and manufacturer demand. Several firms have been involved in lawsuits over the disputed authenticity of raw hoodia (² (Also see "Hoodia Lawsuit Could Plant Seeds Of Concern Over Ingredient Testing" - Pink Sheet, 14 Jul, 2008.), p. 9).

"How can you have almost no raw material and then products flooding the marketplace? That means you have economic adulteration," Shao, CRN's VP of scientific and regulatory affairs, said in an interview.

He added that firms had free rein to sell questionable hoodia products until the Federal Trade Commission stepped up its enforcement. FTC recently filed an injunction against suppliers for making unsubstantiated weight-loss claims and misidentifying adulterated hoodia (³ 'The Tan Sheet' April 27, 2009, In Brief).

Kennedy said near real-time data the Department of Commerce collects on raw agricultural imports can be analyzed for unusual spikes. Those changes can point to potential adulteration of products in high demand.

However, such analysis is difficult because DoC generally does not track raw supplement ingredients, said Daniel Fabricant of the Natural Products Association in an interview.

That makes NPA's work with foreign ingredient exporters all the more crucial, he said.

"Part of the reason we have an office in China is to keep our ears to the ground and see, is there an uptick in certain ingredients, and if so why? And is it even reasonable for it to be there?" said Fabricant, NPA's VP of scientific and regulatory affairs.

Scientific Shortcomings

Science is not keeping up with "fad" supplement ingredients, opening the door wider for criminal adulteration, according to ConsumerLab.com executive William Obermeyer.

Identity tests that supplement manufacturers use largely lack marker compounds for hoodia, which is often replaced with extracts from other cacti species, said Obermeyer, VP of research for the White Plains, N.Y.-based consumer product testing firm.

Chondroitin is another prime target for adulteration, Obermeyer said. In the joint support products it tests, ConsumerLab often finds no chondroitin - an expensive material sourced from animal cartilage.

Juices and supplements made with superfruits such as mangosteen and goji and acai berries are also "ripe for adulteration," he said in his presentation. As Central and South American sources fail to keep pace with demand for the fruits, opportunists in China will fill the void, he added.

Acai has grown in popularity due to its supposed weight-loss benefits. Adulterated acai may be dyed to appear more concentrated (⁴ (Also see "Acai Offered As Bait In Latest Marketing Scams To Draw Investigations" - Pink Sheet, 30 Mar, 2009.), p. 18).

The American Herbal Products Association attempts to advance the science on botanical extracts by issuing guidance documents on identification methods for hoodia and other ingredients.

In ⁵ comments submitted May 6, AHPA asks FDA to consider including in its definition of EMA the alteration of a substance to make it "conform to existing identity and other quality tests of the genuine article."

FDA is accepting EMA comments through Aug. 1.

Demanding Supplier Compliance

Shao said manufacturers enable adulteration when they "turn a blind eye" by buying cheap ingredients and testing ingredients with nonspecific assays.

While industry must take responsibility and understand ingredient risks, he said FDA must ultimately be the enforcer and U.S. Pharmacopeia must update the reference standards for materials firms use.

Obermeyer suggested that bringing raw ingredient suppliers under the requirements of supplement good manufacturing practices would ease the burden on finished product manufacturers (see story p. 5).

By requiring materials testing at the supplier level, "you could stem probably a lot of the economic issue of overtesting, but also start getting back into where the supply chain is going wrong," he said.

AHPA, CRN and NPA have all voiced opposition to the idea of mandating GMP certification for ingredient vendors. The groups argue the GMPs were written to ensure the quality of finished products, not ingredients, and GMP-compliant manufacturers must be responsible to choose quality suppliers (⁶ (Also see "Ingredient Suppliers Not Subject To GMP Finished Product Rule ... Sometimes" - Pink Sheet, 29 Oct, 2007.), p. 3).

- Dan Schiff ([email protected])