Pharma vs. Food Grade

Quick, fast, simple difference …

Food items, additives and supplements are tested for purity to a different standard than drugs – pharmaceuticals. For instance, food grade serine, which is less expensive, can have up to 100 ppm (parts per million) of mold whereas pharmaceutical grade serine is limited to no more than 10 ppm. That is 10 times “purer,” or 10 times less impurity allowed in pharmaceutical grade serine. Stringent testing, to make sure something used as a “drug” is pure and safe, costs more money. This makes sense … drugs are often taken in a higher quantity, taken daily, possibly many times a day, and often for an extended period of time, if not for life. Keep reading if you want to know more.

More information, facts, examples …

(emphases in quotes are mine)

The United States Food and Drug Administration (FDA)

… is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. The FDA is also responsible for the safety and security of most of our nation’s food supply, all cosmetics, dietary supplements and products that give off radiation.

(From the FDA.gov website)

At some point before reaching the consumer, food items and drugs (at least their ingredients) are tested for purity and appearance, and more. These tests must be against some standard, i.e.: how much contaminants are acceptable, how pure must it be, etc. Where do these standards come from?

The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.

The USP Mission

To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

(From the USP.org website)

Basically, the USP has standards that the FDA follows for drugs, food ingredients, and dietary supplements. These are found in the USP-NF, the book of standards.

For more than a century, the United States Pharmacopeial Convention (USP) and the U.S. Food and Drug Administration (FDA) have worked together to protect the public health and promote the quality and safety of drugs, dietary supplements, and foods.  (USP.org)

The United States Pharmacopeia and The National Formulary (USP–NF) is a book of public pharmacopeial standards. It contains standards for (chemical and biological drug substances, dosage forms, and compounded preparations), excipients, medical devices, and dietary supplements. (USP.org)

In 2006, the USP assumed responsibility for the publication of the FCC, the Food Chemicals Codex.

The FCC is a compendium of internationally recognized standards for the purity and identity of food ingredients. It features over 1,200 monographs, including food-grade chemicals, processing aids, foods (such as vegetable oils, fructose, whey, and amino acids), flavoring agents, vitamins, and functional food ingredients (such as lycopene, olestra, and short chain fructooligosaccharides).(USP.gov)

Note that the FDA considers L-Serine a food additive and being an amino acid, it is also considered a dietary supplement. Other food additives include Sodium Chloride (table salt), Vitamin C, Paprika, and Basil (the entire list is here).

A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement or enhance the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders. Whatever their form may be, the Dietary Supplement Health and Education Act of 1994 places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement.

… Because dietary supplements are under the umbrella of “foods,” FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency’s oversight of these products. Information on how FDA regulates dietary supplements is available from the CFSAN Web site.(here)

When evaluating the safety of a substance and whether it should be approved, FDA considers: 1) the composition and properties of the substance, 2) the amount that would typically be consumed, 3) immediate and long-term health effects, and 4) various safety factors. The evaluation determines an appropriate level of use that includes a built-in safety margin – a factor that allows for uncertainty about the levels of consumption that are expected to be harmless. In other words, the levels of use that gain approval are much lower than what would be expected to have any adverse effect.  (FDA.gov)

We carry two types of L-Serine. One has been tested to pharmaceutical standards and meets USP, EP, and JP standards. The other has been tested to USP food grade standards.

You can see our Certificates of Analysis here.