April 2008 Issue

How’d They Do That? A Behind-the-Scenes Look at the Making of Dietary Supplements
By Sharon Palmer, RD
Today’s Dietitian
Vol. 10 No. 4 P. 46

Take a journey with Sharon Palmer as she uncovers the mysteries of how vitamins, minerals, and dietary supplements make their way to store shelves.

What, where, when, why, and how? These are the questions that consumers are asking more frequently about the U.S. food supply. Perhaps it’s a postindustrial awakening; regardless, people have become fascinated about the making of everyday products.

Not so long ago, people were content to simply consume foods, blissfully unaware of how those items found their way onto polystyrene trays or into cardboard boxes. But now they have oodles of questions before taking a bite. No wonder television programs like How It’s Made, which showcases the nuts-and-bolts details behind creations such as Goldfish crackers, have become popular, helping feed consumers’ hunger for information. When the book Twinkie, Deconstructed: My Journey to Discover How the Ingredients Found in Processed Foods Are Grown, Mined (Yes, Mined), and Manipulated Into What America Eats becomes a hit, you know that food fact finding has gone mainstream.

As a dietitian, I am probably more fixated on how food products are fabricated than the average person. I admit that I sat glued to the television set as millions of Goldfish crackers made their way down a conveyor belt on their journey to a cardboard box. When I’m picking through produce at the grocery store, I contemplate the steps it took to get the organic zucchinis from Mexico into my hands in the dead of winter. And for some time now, I’ve been brooding over the vast complexity of getting all of those tiny micronutrients into the multivitamins and minerals that I pop each morning. Where did they come from and how did they get there? I should know; after all, I’m a dietitian.

So came about my quest for better understanding of how dietary supplements are manufactured. I scheduled a tour of a nearby dietary supplement plant, Vitamer, located in Irvine, Calif., eager to learn how vitamins, minerals, and nutrients find their way to store shelves as dietary supplements.

Opening the Door
Driving down the I-5 freeway on a Monday morning, I am en route to Vitamer Laboratories. The plant is located near a network of freeways and the John Wayne Airport, which I imagine helps speed the delivery of those cardboard boxes filled with dietary supplements I notice at the loading dock as I park my car. The building resembles the nearby industrial centers that probably pump out myriad products on which Americans have become dependent.

To my immediate pleasure, I am greeted by Jane Drinkwalter, vice president of sales, and Erin Silva, MS, RD, CNSD, technical marketing manager. Drinkwalter, a 20-year veteran at Vitamer, informs me that her mother was a hospital dietitian, which prompted her own interest and subsequent degree in nutrition. Silva worked in clinical dietetics before taking a post in marketing and product development, which includes responsibilities such as producing a newsletter that includes an “ask the dietitian” column and nutrition information for consumers. Vitamer, a family-owned company that’s been around for 80 years, is a private label brand partner, which means that its products carry the brands of retailers across the country.

When I explain my mission—gaining a better understanding of supplement creation—Silva says, “There are many consumer misconceptions about how dietary supplements are made. Dietitians should be aware of what goes on behind the scenes and be able to answer these questions,” adding that customers ask many questions about ingredients in supplements.

Vitamer produces a long list of supplements, including standard vitamin and mineral preparations, herbs, botanicals, amino acids, enzymes, protein powders, antioxidants, and targeted preparations such as heart health, eye health, and healthy weight support supplements. In addition, Vitamer manufactures organic and vegetarian supplement lines. When asked how Vitamer stays above the fray of unproven supplements that stir up trouble for the industry, Drinkwalter responds, “We make our decisions about developing products based on science. For instance, we decided not to make coral calcium.” Coral calcium has come under scrutiny because one purveyor of the supplement alleged that it cured up to 200 diseases, in addition to other false statements relating to the product. At a fraction of the cost of coral calcium, calcium carbonate is recommended as an appropriate source of calcium supplement, especially considering lead contamination has been found in some coral calcium supplements.

Inside the Lab
Our first tour stop is the lab, and I come prepared with plenty of questions about product testing. Since dietary supplements fall under the Dietary Supplement Health and Education Act (DSHEA), the FDA regulates supplements as foods, not drugs. Historically, supplement manufacturers are not required to prove the safety or effectiveness of their products, and the FDA can take action only after a dietary supplement has been proven harmful. Like drug makers, however, dietary supplement manufacturers must submit notification of sale to the FDA within 30 days of market.

There has been a great deal of controversy in this industry due to unreliable products swimming in the same tank as reputable ones. Today, you can read reports on ConsumerLab.com detailing which supplements failed tests due to nutrient levels below listed amounts, lead contamination, and products that do not break apart appropriately for absorption. Stories about contaminated supplies from other countries have also been widely publicized. Thus, quality has become a big topic in the dietary supplement world.

The good news is that last year, the FDA issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. The requirements include provisions for the design of physical plant maintenance, cleaning, manufacturing operations, quality control procedures, testing final products or incoming materials, handling consumer complaints, and maintaining records. For large companies, the final CGMPs must be in place by June.

As I’m ushered into Vitamer’s lab, I’m pleasantly surprised to see several rooms containing numerous machines and technicians busily testing ingredients and products. There are rooms with dissolution machines, titrating equipment, atomic absorption machines, microbiology labs, and gas chromatography machines. A multitude of tests are being performed on random samples of incoming raw materials, products during phases of manufacturing, and completed products. Vitamer has specifications in place for each step of supplement manufacturing. Products are tested for identification, potency, disintegration, contamination, and microbial content.

Vitamer utilizes third party GMP certification, a growing trend in the industry. It received an “A” from the National Nutrition Foods Association (now known as the Natural Products Association) in 2000 for strict adherence to GMPs. Drinkwalter is confident that Vitamer will be in compliance with the FDA GMPs once they go into effect. I leave the lab feeling confident that Vitamer’s supplements contain what they’re supposed to contain.

Raw Ingredients Entry Point
Next we head to Vitamer’s point of entry, where raw ingredients are delivered to the back door. Supplement makers purchase their arsenal of raw ingredients for their products much like foodservice managers purchase their ingredients for their menu. Drinkwalter reports that Vitamer works with suppliers from around the world, and all are required to meet established specifications for raw ingredients. Raw ingredient shortages are common, so Vitamer maintains relationships with three to five suppliers for each material, each providing a certificate of analysis for every batch of raw ingredients.

One thing weighing heavily on my mind is the issue of imported ingredients, especially from China. Drinkwalter says that all ingredients are rigorously tested, no matter where they originate. The Natural Products Association is currently working on a new testing program for products from China to help resolve quality concerns arising from Chinese exports. As it stands, Vitamer rejects about 2% of its raw materials.

And how are the raw ingredients made? Does the vitamin C come from lemons and the fish oils from fish? According to Silva, some ingredients do not come directly from foods. For instance, vitamin C is usually in the form of ascorbic acid and the starting source is corn dextrose; beta-carotene typically comes from algae; and minerals are commonly found through mining.

But other ingredients come directly from food sources. Herbs are indeed made from parts of herbs themselves, which supplement bottles indicate. Extracts are obtained from plants; for example, Vitamer’s pomegranate extract comes from pomegranates. Vitamer’s organic vitamin C is derived from acerola fruit, and lutein is extracted from marigold flowers. Silva reports that much of the omega-3 fatty acid supply comes from cold water fish such as sardines and anchovies from the coasts of Peru and Chile. The supplement label often provides a clue as to the source of some ingredients.

I am struck by a sign on the wall in the entry area that reads “Raw Materials Quarantine.” Each delivered ingredient is labeled with a quarantine sticker and cannot leave this area until a sample is tested. Then the product receives a bright green release sticker and moves on to the raw materials storage area.

The raw materials in boxes, drums, and bags sit neatly on the warehouse shelves, identified in detail by their origin and content. This area is much like a pantry in a large foodservice operation, where ingredients are pulled to create “recipes” that will become supplements. The warehouse is maintained at a constant cool temperature.

Scheduling a Supplement Job
We move on to the production area and approach a job scheduled by a team that has carefully coordinated all of the batches that will be prepared for the day. I peer through the window of a sealed weigh room and watch two employees carefully measure and weigh the ingredients required for chewable vitamin C tablets. The room is posted with a sign that indicates the job and batch number for this job. One employee weighs the written ingredients, which have been pulled from the released raw materials inventory, and the other double checks the measurements. A manager signs off on this process. When the workers are finished measuring the ingredients, they exit the room and place a “dirty” sign on the door. The room will not be used for the next batch until it is cleaned and a sign is placed on the door that reads “OK to use.”

Whipping Up Vitamins
The next vault of sealed rooms we approach contain massive blenders used for mixing the batches of supplements. I peek into the windows of the sealed rooms, again marked with batch numbers, as workers attend to the mixers blending batches of supplements that were measured in the weigh room. Long before the ingredients entered these rooms, Vitamer’s research and development team carefully tested and studied procedures to design the supplement formulas currently in use. When the batches are finished and transported to the next phase of manufacturing, the rooms are marked with a “dirty, do not use” sign. Silva explains that this kind of caution is essential to prevent cross-contamination, which is especially important to avoid due to the growing number of consumers with gluten intolerance.

Firing Up the Ovens
In the next area, I discover tall rows of ovens with slots accommodating trays of apricot-colored powder. Drinkwalter explains that sometimes raw ingredients do not mix well, so a liquid must be added to the process. Workers must draw this moisture out of the product by drying the mixture, so they stir the apricot-colored mixture on the trays while cooking it at low temperatures. When this batch is complete, workers will thoroughly clean the area before preparing the next supplement order.

Punching Out Vitamins
We follow the supplement trail to sealed rooms that house encapsulating machines. When the supplement recipe is mixed to perfection, these encapsulating machines punch out supplements like high-powered cookie cutters. One gleaming high-tech machine can pump out 50,000 capsules per hour. These machines are fitted with die punches of varying shapes and sizes that produce the desired tablets; there’s even an animal-shaped tool for children’s chewable vitamins. Before the supplements leave this area, they are tested for size, hardness, thickness, and weight. As in other areas, the rooms are marked as dirty when a job is done and must be cleaned before the next job can be scheduled.

Coating ‘Em Up
In the next area, a giant tumbler in a sealed room is tossing around beige supplement capsules like thousands of socks in a dryer. A worker introduces a green chlorophyll liquid into the tumbler that will form a green coating on the supplements. Drinkwalter explains that most supplements require a coating, which is usually clear and aqueous, so that the tablets have smoother edges for packaging, maintain better shelf life, and are easier to swallow.

In another sealed room, a machine prepares gel capsules in the manner of a giant waffle iron, fusing each half of the gel capsule with the ingredients in the middle. When these batches are finished, the rooms are marked as dirty until they can be cleaned for the next job.

Bottling Business
We now reach the end of the line. Long rooms contain neat, automated lines with workers monitoring the packing of supplements into Vitamer’s amber glass bottles, which the company believes offer the best protection for supplements. A bin of finished product that has made its way through each step of manufacturing is now emptied into a chute hovering over the packing line. A machine counts the capsules dropped into each bottle, a rayon cotton stopper is placed into the bottle, the plastic lid is sealed in place, the bottle is heat sealed with plastic, and the lot number and date are stamped on the bottom. The bottles are then packed into boxes and readied for shipment. The packing line must be cleaned before the next job. A sample of every batch is retained for one year after the best by date in case a problem occurs with that batch.

Now at the end of my journey of discovery, I find myself equipped with new understanding about the making of supplements—but more questions linger on my lips. With the FDA CGMPs not yet in place, is Vitamer’s level of quality control the exception or the norm for supplement makers? I put that question to Daniel Fabricant, PhD, vice president of scientific and regulatory affairs at the Natural Products Association. “I have had the opportunity to visit many facilities, and while Vitamer is certainly a terrific firm, I think by and large with firms that are willing to invest the capital in putting the controls in place and go through programs like our third party GMP certification, it really is the norm these days,” he says.

That makes me feel better. Now I’m dying to know how they make Cheetos…

— Sharon Palmer, RD, is a contributing editor at Today’s Dietitian and a freelance food and nutrition writer in southern California.