McCain to America: You Have No Choice

On February 2, 2010, Senators John McCain and Byron Dorgan introduced the Dietary Supplements Safety Act (DSSA), also known as S2310.  This bill would amend the Federal Food, Drug, and Cosmetic Act, and would repeal large portions of the Dietary Supplement Health and Education Act of 1994 (DSHEA).  The purpose of the bill is to give the FDA unprecedented and extreme control over the ingredients used in dietary supplements, supposedly to protect the consumer against large numbers of dangerous, adulterated supplements on the market.  According to McCain’s speech and press release, he was moved to create the Act in response to the news that six NFL players had been disqualified from season play due to having unknowingly taken steroid-adulterated supplements.

The problem with McCain’s claim, of course, is that the adulteration of athletic performance supplements with steroids is a well-known problem which has been proven to exist with the knowledge and collusion of many athletes and trainers, and which stands completely apart from the normal supplement market.  Whatever Joe and Jane Athlete are doing, knowingly or not, Joe and Jane Average and their kids aren’t gulping down dozens of steroid-laced pills daily in an attempt to bulk up their muscles or improve their performance at the next big game.  Instead they’re taking herbs, vitamins, minerals, amino acids, and other GRAS products to improve their energy levels, vitality, digestion, memory, weight, immune system function, and various other routine health concerns.  Joe and Jane Average are, in fact, using supplements in place of over-the-counter pharmaceuticals “to treat conditions a normally prudent person would treat at home”, if we may borrow the classic phrase which draws the line between OTC and prescription drugs.

That being the case, McCain’s bill as a response to adulterated performance supplements is equivalent to using an elephant gun to kill a medium-sized squirrel.  Not only would he potentially miss the target entirely, the resulting discharge will mangle everything within a fairly large radius of the target’s location.   That promises to be exactly the effect of his bill, if it becomes law.  It would outlaw steroid-adulterated supplements, but that’s not necessary because they’re already illegal and the problem is purely one of enforcement.  It would also outlaw many safe and harmless supplements, and would give the FDA powers that make those of a totalitarian dictatorship look modest.

How so?  To start with, McCain’s bill would require “any business or operation engaged in manufacturing, packaging, holding, distributing, labeling, or licensing a dietary supplement for consumption in the United States” to register with the government or have its products automatically classed as adulterated.  The registration requires a list of the names and addresses of all facilities the company owns or uses, all trade names under which it does business, a complete list of product names and ingredients for products which the company manufactures, sells, packages, labels, licenses, or distributes, with a copy of the label for each product in question.  This registration must be repeated annually, with updates reflecting all changes.  Moreover, any changes in the products or their labeling may not be put into effect until after the registration has been updated.

Chilling, isn’t it?  Wait; it gets worse.  Any ingredient which does not have an existing body of evidence for its safety and an existing track record of safe use in the manner recommended by the product labeling, or which has not been placed on the approved list of “Accepted Dietary Ingredients” maintained by the Secretary of the FDA, will be deemed an adulterant unless it is registered. The registration process includes providing the FDA with clinical proof of the ingredient’s effectiveness and safety for the suggested usage, and requires that the registered ingredient be approved for use at least 75 days before the product is made available to distributors.  The grandfathering exemption made for ingredients in common use before DSHEA was passed in 1994 would be repealed.  So would the exemption for ingredients which are in common use as foods.  While any supplement already established in the US Pharmacopoeia is probably ok unless the FDA Secretary chooses to remove it from the approved list (you might be allowed to keep your peppermint tea and slippery elm lozenges), such terribly dangerous substances as goji berries, lemon grass, L-Lysine, gotu kola, and neem oil will be classed as adulterants until they’re proven safe.

Oh, and the registrations?  The business registering the ingredient must maintain a file of evidence for the ingredient’s safety.  The DSHEA already requires manufacturers to ensure that an ingredient is safe before including it in a product, but it doesn’t impose an undue burden of record-keeping.  McCain’s billl will take care of that.  Not only must the businesses who are required to register an ingredient keep records on its safety, but any downline business which handles products containing the ingredient, from the distributor to the storage warehouse to the retailer, has to maintain a file of proof that they have verified that everybody upline from them is in compliance with the registration requirement.  That clause alone will put many distributors, warehouses, and shops out of business by costing them hundreds of hours of administrative time, creating and maintaining those files.  Nothing eats up profits faster than the overhead of endless paperwork, as anyone who has had to comply with Federal regulatory requirements can testify.  Other costs would hit those who refuse; failure to comply means being fined up to twice the gross profits of your sales of the item.  Are we having fun yet?

Not compared to how much fun it will be if you keep reading the bill.  Where present legislation requires the reporting of serious adverse events connected to a dietary supplement, McCain’s bill would require reporting of all adverse events, serious and non-serious.  So if you got acid indigestion from your probiotic kefir, or your child threw up after swallowing one of your memory-boosting ginkgo and gotu kola capsules, or your dog got the runs after eating a package of honey and licorice cough lozenges, those would be reportable adverse events.  Although you may be laughing at the absurdity of these examples, you can’t afford to take it lightly.  The term “non-serious adverse event” is not defined at all in the text of the bill.  It could be construed to include any negative thing, no matter how small or harmless, resulting from consumption of a dietary supplement.  Since in an average year very few actually serious adverse events are reported for dietary supplements, somebody has evidently decided to boost the numbers with minor complaints instead.  If they can’t get deaths and organ failures and permanent disabilities to use in their anti-supplement campaigns, they can get stomach aches and rashes and headaches instead.  These non-serious adverse events must be recorded by anyone in the manufacturer-to-seller chain of companies who handle the products, by the way, and must be reported annually to the FDA.  Or Else.

We’re not done yet.  Now comes expanded restriction and recall authority for the FDA!  Even though the FDA’s existing powers enable it to initiate a stop-sales order or recall of any questionable dietary supplement the moment evidence of a problem arises (or is manufactured), McCain’s bill enables the Secretary of the FDA to issue a stop-sales order on his or her judgment that reasonable cause exists to believe that the supplement is dangerous, is misbranded, or is adulterated.  Under the text of the bill, no proof is required, only an otherwise undefined “reasonable probability”.  If the Secretary orders a product to cease sales and distribution, the affected businesses may request a hearing, but the Secretary retains the power to determine if the original order was valid or not, and retains sole power to order a full recall on his or her own judgment.  Again, proof is not required, only the Secretary’s personal determination of whether “adequate grounds” exist.  It’s certainly not necessary to spell out the potential for abuse in that blanket permission.  Anyone with half an imagination can see what’s coming.

There you have it: the gist of 12 pages of bureaucratic doublespeak that, if passed into law, would destroy nearly the entire supplements industry and much of alternative healthcare — and almost certainly, some of mainstream healthcare as well.  The voices raised in opposition begin with such prominent natural healthcare rights advocates as Natural Solutions Foundation head Dr. Rima Laibow, civil rights attorney Jonathan Emord, and the Council for Responsible Nutrition, but they don’t end there.  More mainstream medical luminaries such as Dr. Nicholas J. Gonzales, a cancer specialist who advocates patient use of controlled diet, nutrients, and proteolytic enzymes to fight often otherwise untreatable cancers, have issued public appeals asking Congress to defeat McCain’s bill.

You can add your voice too.  If you are an American voter, contact your Senators and let them know how you feel about Senator McCain’s bill.  An old-fashioned written letter, an email, a telephone call, or, if you use Twitter, even a tweet, will have some impact.  So will letters and messages of support sent to Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT), sponsors of the DSHEA, who are expected to lead the opposition to this legislation.  Whether or not you are an American voter, you can take action by contributing to the war chest of organizations fighting McCain’s bill.  Money donated to one or more of the health freedom advocates listed above, or to any group that’s fighting this legislation, won’t be wasted.  Even $5 can help make a difference, and in a fight like this every little bit helps.  Many of the hardcore Pharma advocates are already saying McCain will lose this issue if all of the people who use alternative medicine and dietary supplements speak up against the bill.  We think they’re right, but only if everyone who stands to be hurt by this legislation really does speak up instead of deciding that since so many other people will, you don’t need to.  This is a time to take action.  If you “let George do it”, you’ll lose some of your most precious assets for staying healthy.  For everyone’s sake, don’t make that mistake!