| In the news recently, there have been warnings | | | | bring onto the market for over the counter sale, the |
| about toothpaste manufactured in China that contains | | | | label must be in compliance with FDA regulations. The |
| a poisonous ingredient that is usually found in | | | | proposed product label is sent to a lawyer that |
| automobile radiator coolant. Rather than focus on the | | | | specializes in FDA regulations. They check to make |
| negative aspects of this news, and the poor | | | | sure that there are no false health claims on the label, |
| standards used in manufacturing and exporting | | | | and that each and every ingredient is on a list issued |
| maintained in other countries, it may be a really good | | | | by the FDA as GRAS (generally regarded as safe). |
| time to reflect on the standards that the American | | | | This is a list of ingredients that include chemicals, |
| manufacturer maintains in the production of personal | | | | botanical and inert ingredients that have been tested |
| care products that we have, until this time, taken for | | | | and have been cleared as being safe for consumers |
| granted. | | | | to use. The approved label is sent back to the |
| A consumer gives little thought when they pick up | | | | manufacturing facility. Each product must have an |
| their toothpaste in the morning as to the safety of | | | | approved label on file in the manufacturing facility |
| the ingredients or packaging that goes into producing | | | | where it is manufactured. Aside from the labeling |
| that tube. We expect that there will be protections | | | | considerations, the FDA also inspects the |
| for us as consumers against shoddy manufacturing | | | | manufacturing facilities. Among the things they |
| practices, but usually little is known about the | | | | inspect are the water systems. For example, if |
| process. | | | | purified water is used in products, there must be an |
| The first step a manufacturer goes through is the | | | | exact log on file of the tests that were done on the |
| state and local licensing of the laboratory or facility | | | | water when the manufacturing process on a |
| where the product is to be made. Facilities are | | | | particular product begun, and again, at the end of |
| inspected to make sure that the building and areas | | | | that product run. There must also be a log of |
| are clean and adequate for the process that is | | | | batches or lots of each product and the date of the |
| proposed, and that all systems are sanitary. There | | | | manufacture. Each product must have a lot number |
| are OSHA (Occupational Safety & Health | | | | and expiration date stamped or crimped onto the |
| Administration) safety standards with which the | | | | product. When a product such as toothpaste is |
| facility must comply, which include having safety data | | | | finished, it is tested for quality and purity. It must |
| sheets on file for every chemical or ingredient used in | | | | then remain in quarantine for several days, and then |
| every product manufactured or used for cleaning on | | | | retested for bacterial contamination before it is |
| the grounds of the facility. | | | | released from the manufacturing laboratory for |
| State and local laws including wages, insurance and | | | | distribution. |
| safety standards cover employees. Lab workers are | | | | When a comparison is made between the high |
| required to wear disposable paper head covering at | | | | standards that must be met by the American |
| all times, and in the formulating areas, protective | | | | manufacturer of toothpaste and a product made in a |
| clothing such as lab coats are worn. Workers in other | | | | country with little or no oversight on manufacturing, |
| countries often work in unsanitary and abysmal | | | | ingredients or the facilities in which they are |
| working conditions and are paid a miserable wage. | | | | produced, it makes little sense NOT to buy |
| Then there are the labeling standards set forth by | | | | toothpaste proudly "Made in the USA. |
| the FDA. When a new product is being developed to | | | | |