cGMP Manufacturing for Pharma Foods Available from PCI Synthesis, Now Also a Certified Food Manufacturer


Yogurts augmented with probiotics, or cereals containing additional health-boosting fiber – are they a food or medicine?  Whether considered one or both, such functional foods—those that have some augmented health benefit—are a fast-growing trend that is rapidly driving growth in the grocery industry. Supermarket News cited healthy foods as one of the top trends in 2017, and Retail Info Systems, which supplies software to the industry, expects the trend to continue to grow in 2018 as more consumers seek food options they consider to be healthier.

Learn how to accelerate your API manufacturing project »

That of course is nothing new. According to management consultant Peter Leighton, self-care has deep roots in the U.S. as the old 1920’s adage, “An apple a day keeps the doctor away” exemplifies. Since that time, as information about the relationship between health and the foods we eat proliferated in the media, people have increased their intake of supplements and nutraceuticals such as protein powder, fish oil and vitamins. Today we are seeing this movement expand into foods that have even greater, scientifically verified health benefits that go beyond basic nutrition—pharma foods.

Pharma foods defined

Pharma foods are a new frontier that is blurring the lines between pharmaceutical companies and food companies. What distinguishes pharma foods from nutraceuticals such as memory enhancement pills or vitamins is that they can’t be bought off the shelf. They must be prescribed by physicians and distributed by pharmacists.

They are generally defined as a food product with a pharmacological additive meant to improve health.  A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

Pharma foods are wide open to innovation, and companies from Nestle to Abbot Labs are jumping in. Many others, large and small, are too.

One of our medical foods customers, after conducting clinical research that showed a strong correlation between certain disorders and lipid imbalances in affected individuals, developed nutritional-based products for lipid imbalance-caused health conditions such as hypertriglyceridemia. According to the company, diet alone cannot improve the condition.

Pharma foods aren’t just consumed by humans. Companies are also developing pharmaceutical-grade foods for the veterinary market.

Are pharma foods regulated?

In addition to regulating active pharmaceutical ingredients (APIs), the FDA also regulates medical foods, but with a different pathway than drugs.

In its medical foods guidance, the FDA specifies that manufacturers of medical foods must comply with all applicable FDA requirements for foods. In order to be considered by the FDA as a medical food, however, the products must meet several requirements. These relate to the quality and safety of the products:

  • Produced under current Good Manufacturing Practice (cGMP).
  • Ingredients used must be generally recognized as safe (GRAS).
  • Product development must be based on recognized scientific principles.

And generally, pharma foods require clinical trials if a health claim is to be made. The product cannot claim to be curative. Basically, company claims can say this won’t hurt you, and taking this product might help.

Market growing rapidly

Nutrition-based therapies are attractive to the many people who prefer to try something perceived as more natural than drugs.

It’s a big opportunity. A KPMG report cites a $250 billion market for functional foods by next year, up fivefold from 1999.

Economics of pharma foods

It is well known that when it comes to selling foods, margins are razor thin. This price sensitivity also holds true for pharma foods. As a result, it makes good economic sense to produce pharma foods in larger quantities, especially given that the cGMP manufacturing required is costly to begin with.

Consequently, in addition to our robust cGMP capabilities, pharma food companies seek us out for our 2,000-gallon vessels, which can produce these products in bulk.  As well, PCI Synthesis is a Certified Food Manufacturer licensed by the State of Massachusetts.

Safety is a major factor

Health scares, such as tainted baby formula in China, have played a role in the growing market for functional foods that are produced in an FDA-regulated facility under strict regulatory guidelines. Consumers are willing to pay more for the added safety for themselves, their children and their pets.

Consumer interest high

Studies show that 6 in 10 U.S. adults consume functional foods at least occasionally, and that nine in 10 express interest in consuming foods with potential to improve their health. While manufacturing under cGMP is usually limited to pharma foods that are prescribed by health providers, innovative pharma and food companies, or partnerships among them, may soon decide that protecting consumers with cGMP manufacturing makes good business sense even when prescriptions are not required.

At PCI Synthesis, we have first-hand experience with the rise in the demand for pharma food manufacturing. We have several projects, and understand how to work with pharma food companies. They come to us for our cGMP manufacturing expertise but stay with us because we can work with them on their terms, since one of the factors we seek to understand for every sponsor is their business model. That helps us understand their goals. Knowing that, we can make smarter recommendations that are based on the sponsor’s needs.

If you’re interested in how we work with pharma food companies, please call us at (978) 462-5555 or email us at