Tuesday, July 22, 2008

The FDA Globalization Act of 2008

I’d like to preface this by stating that I’m probably going to catch some of flack over this from my husband the chemist. And others, as well, I am sure.

That said, it seems to me that the FDA Globalization Act of 2008 was written to help put some teeth in the FDA’s bite – or lack of bite, as it were. And that, to me, is a good thing.

We’ve all witnessed the pitiful job FDA has done in bringing to the current salmonella outbreak to a close. And I mean pitiful. It took FDA 14 weeks and a thorough bashing of US tomato growers to finally track the source of the salmonella to a jalapeno farm in Mexico. If the FDA were better funded, perhaps things would have gone better – and more quickly. Or maybe not, but after all these years of underfunded-ness, it seems that Congress finally wants to make a course correction and pump some badly needed money into the FDA.

Some people would like us to believe that giving the FDA greater authority and funding is a bad thing, and that those of us who would like to see improvements in record keeping and manufacturing processes should be “condemned”. They seem to think that anyone who agrees that something needs to be done is a “big business”. Well, I’m here to tell you that not everyone who finds good in this Act works at P&G or Revlon or Publix Markets, or brings home a six figure salary, for that matter.

I’m all for sending money to the FDA. Here’s a department of the US Federal government that is charged with regulating the safety of food, drugs and cosmetics within our borders. Not just the domestic side, but importers, too. That’s an awesome responsibility – think about it. What mother in America would not spend whatever it takes to ensure the food she prepares for her children to eat, the drugs they take when their tummies hurt and the mascara their 15 year old daughters are wearing doesn’t meet the highest standards? But all that takes money.

So, where does this money come from? The FDA Globalization Act of 2008 will require makers of lotions, shampoos and other such finished products to pay a $2000 annual registration fee, provide written testimony about and pass a physical inspection of their facility and adherence to Good Manufacturing Practices (GMP: writing down everything you put into your products and the process you used to make them). They will also require the same fee, documentation and inspection from ingredients vendors, such as Snowdrift Farm. If you make and sell or import a cosmetic or the materials needed to do so, you are required to register with the Secretary of Health & Human Services. You think $2000 is a lot of money? Importers pay $10,000! So, if you manufacture lotion and directly import an ingredient you use in the manufacture of that lotion, from say, Madagascar, then you will pay $10,000 to register your ingredient. It’s too bad that Congress can’t come up with the funds elsewhere – or at least help defray the cost of registration to the small manufacturer. Maybe Congress could charge manufacturers and sellers on a sliding scale: instead of imposing the same fee on every company, base your fee on last year’s sales. Alas, no one is exempt.

Well, no one except the soap makers, or so it would seem. Though I have read plenty on internet web sites opposing the Act that infer that classic, cold process soapmakers are included, as long as your soap is cold process and you make no drug claims (like, washing with your soap will make you skinny), your product is exempt from the Act. That’s because, according the FDA, lye-based soap is not classified as a drug or a cosmetic. No registration, no $2000 fee -- unless Congress decides to redefine soap, I suppose. If you know something I don’t know about soap and the Act, please tell me.

In the meantime, the rest of us will need to decide if we should drop the ancillary product range and go for soap and soap alone, or pay the fee and adhere to the provisions of the Act. Honestly, the GMP piece is long in coming. All of us should be keeping good records of our processes, ingredients, lot numbers, batch samples, anyway. But how’s that going to get enforced unless the FDA can hire more inspectors? Well, it can’t.

I understand that many small producers can not afford the $2000 annual fee. Some may not be interested in keeping copious records, either. (While researching, I saw the Act’s GMP requirement referred to as “burdensome paperwork” on the Indie Beauty Network blog. That blew me away! If you’re going to make a product, take pride in it and keep those records!) For those people, it would seem that going out of business or flying under the radar are your choices. Those who can afford the $2000, being registered with the FDA and passing an inspection is part of the price paid to keep non-contaminated ingredients and finished goods out of our markets and hopefully, out of existence. I know the price is high. It is going to force many people to take a long, hard look at what they are doing and how much it means to them and how hard they are willing to work to continue and grow. Many will have to change business plans to adapt to the changes in the law. And it will probably mean a rise in prices in order to pay the fees.

And it’s not just the cosmetic manufacturers who are getting socked with this. Title I of this Act deals with food safety. It requires that even small, kitchen counter producers of cookies, candies and salsa get registered, same as lotion makers. It requires the same of your local food co-op and CSA. Many of these businesses will not be able to afford the $2000 fee, either.

Despite my support of GMP and inspections, I am not in favor of this Act, at least not at this time in American history. When citizens can least afford to spend (even more) money to start a business, Congress is compelling us to fork over $2000. Maybe they could wait until the recession is over before they try to put the kibosh on small businesses? As far as those GMPs are concerned, I say, bring them on. Our sister and brother soap and lotion makers in the European Union have long been compelled to pay fees, record batch numbers, keep samples and disclose their formulae in return for the privilege to sell skin, hair and body care products. And it has made the trade more reliable. We could use some of that here, too.


Golden Goat said...

I agree, except to say that the fee is too high. I have no problem complying with the regulations, but that $2000 fee will put many out of business. There has got to be another way to impose these regulations without putting the little guy out of business. Paying a fee like that will force suppliers to raise their prices. The manufacturer/retailer will then have to raise prices even more to cover the fee and the increase in supply costs. I don't have the answers, but I know that the fee will be a detriment to our industry and will create a loss of many quality products to the public.

Shirin said...

It'll be like Walmart coming in and putting the mama-papa stores out of business.
I know many many small businesses who take pride in their work and deliver high quality products, and if the Act is enforced, many will opt to change business, and all that will be left for us would be mass-produced not-too-great products.

Trina said...

Dear Golden Goat and Shirin,

Thanks for your comments.

I doubt hightly that this Act will pass the way it is written. The House Committee is now hearing testimony on the Act, and I'm sure it will not go anywhere for several months, perhaps into 2009. In any case, there is a lot of good in the Act, and I hope Congress at least sees fit to insist on some GMPs for our industry.