Stop New Bill (HR2749) Gives FDA Unheard-of Power over Small Farmers, Food and Supplement Producers

A new, long-awaited food safety bill is now before the US House of Representatives. It is the Food Safety Enhancement Act of 2009, or FSEA. Introduced by Reps. Henry Waxman (D–CA) and John Dingell (D–MI), the FSEA is meant to address food safety concerns. But as you will see, much of it is not about food safety at all. Food safety issues have arisen from large agricultural operations. But this bill places its harshest burdens on small food producers and supplement producers.

Take Action and let your Representative know you DO NOT support this bill

The Food Safety Enhancement Act:

• gives the US Food and Drug Administration (FDA) unprecedented scope, authority, and power over small farmers, food producers, and supplement producers, including the power to use vague language to intimidate and threaten;
• imposes unjustifiably harsh criminal and civil penalties for even administrative violations; and

• places undue economic hardship on small and mid-sized farms and food facilities (both organic and conventional), which could easily drive many of them out of business, and lead to monopoly control of food by large corporations.

Also known as the Waxman–Dingell bill, the Food Safety Enhancement Act has a number of provisions that would directly affect many of AAHF’s members. Although much of the bill’s language is vague—and, some worry, deliberately deceptive—it is clear that the FSEA provides for the following:

Sharply increased criminal and civil penalties for violations of FDA regulations.

The penalties include prison terms of up to ten years (jail time is currently capped at three years), and fines of up to $100,000 for individuals and $7.5 million for corporations, regardless of their size. The kicker is that these penalties are potentially applicable no matter what way you violate the FDA’s rules.

The application of those penalties to any food, drug, device, or cosmetic that is knowingly "adulterated or misbranded."

To our ears, “adulterated” means that it doesn’t meet good manufacturing practices, that the food itself is somehow tainted or injurious to health, or contains an ingredient that presents a significant or unreasonable risk of illness. And “misbranded” suggests deliberate misstatements about the efficacy of a product.

In FDA-speak, however, these words take on completely different meanings. For example, a food or supplement may be “adulterated” if some vague FDA rule is deemed by the FDA not to have been followed. “Misbranded” can mean that the producer makes a completely true statement about the product but without FDA permission. A cherry producer who cites peer-reviewed scientific research from prestigious universities on the health benefits of cherries would, in FDA-speak, have engaged in “false” and actionable “misbranding” which suddenly turns the cherries into drugs. Producers, of course, have the right to take cherries through the new drug approval process! In this and other ways, the FDA already censors science and quashes constitutionally protected free speech.

In this new bill, any violation of the new administrative requirements could make a product adulterated and/or misbranded. That is, an administrative violation (such as not keeping records exactly as required) that harms no one carries exactly the same penalty as a violation in which a product is adulterated during the manufacturing process and poses a significant risk of illness or ends up killing people.

The dramatic increase in jail time and fines will make supplement production an even riskier proposition than it is today. Supplement producers have to put some information on the bottle. They try their best to satisfy FDA rules, which can only be described as gray, not black and white. Now if they get it wrong in the eyes of the FDA, the potential penalties will be extremely severe.

Many on Capitol Hill are under the impression that the bill pertains only to food, but the FSEA language specifically names supplements as well, and this will have a huge potential impact on any small company brave enough to continue their manufacture and sale.

Large companies will probably be unaffected because they can afford the extensive legal staff needed. Moreover, the FDA does not try to put large companies with political clout out of business, much less put their executives in jail. General Mills (the manufacturer of Cheerios) was recently cited by the FDA for an unapproved health claim, even though the company was reporting good science. Under the new bill, General Mills could be fined $7.5 million, but based on past FDA performance this would be unlikely. If a tiny company were cited, the exact same fine would be applicable and the likelihood of being exacted would be much greater.

FDA control of farming standards and practices

Many people on Capitol Hill seem to believe that farms are exempted from the FSEA’s scope. That is false. On the contrary: the bill would empower the FDA to regulate how crops are raised and harvested. It puts the FDA, which knows nothing about farming, right on the farm, dictating to our farmers. Specifically, it allows the FDA to set “scientific and risk-based standards” for the use of fertilizers, harvesting and processing methods, transportation, etc. Any non-compliance means the food is to be considered “adulterated” (with fines of up to $100,000 per individual and $7.5 million per corporation, and a jail term of up to ten years).

For example, based on both its public statements and its record, the FDA is vehemently opposed to the consumption of raw milk (even in cheese) and would like to ban its distribution. If HR2749 becomes law, the agency would have much greater scope to go after raw milk than it did before, particularly targeting raw milk producers whose products cross state lines.

Raw milk is just one example. The FDA can decide that it doesn’t like anything under this bill. And we can be sure that large producers will have easy access to the agency to explain why competing products from small producers should be banned.

Moreover, the bill would give the FDA the power to order a quarantine of a geographic area. Under this provision, farmers markets and local food sources could be shut down, even if they are not the source of the contamination. The agency could halt all movement of all food in that geographic area.

The language is incredibly vague and does not distinguish between industrial-sized operations, organic farms, or smaller operations—the FDA could easily use its new authority to set requirements that only large corporate farmers can meet. While farms are exempt from some sections of the FSEA legislation, they are explicitly included in this all-important section. Smaller farmers who can’t meet the new FDA requirements will simply go out of business, unfairly creating monopolies for the huge corporations. We believe the FDA should not have this kind of authority over farms at all, but this one-size-fits-all approach has significant economic implications and could destroy a sustainable farm trying to comply with an inappropriate commercial standard.

An unequal burden for smaller and local food facilities

A food facility—defined as any factory, warehouse, or establishment that manufactures, processes, packs, or holds food—must, under the new bill, register and pay an annual registration fee of $500 (and that fee would be adjusted upward with inflation). Although farms and restaurants are exempt, the agency has defined “farm” narrowly, and people making small batches of foods such as lacto-fermented vegetables, cheeses, or breads would be required to register and pay the fee, which could drive start-up and small producers out of business during difficult economic times. A flat fee that does not take into account the size of the facility is good news for giant agribusinesses, but may represent a serious economic burden for some smaller companies struggling to make ends meet. How could the FDA think that the same fee (and penalties) are as appropriate for Mom-and-Pop operations as for ConAgra?

Moreover, FSEA provides for mandated electronic registration, which may be an issue for smaller producers, and is certainly a problem for Amish farmers, for whom the electronic filing requirement violates their religious beliefs. Failing to register a food facility would constitute “misbranding”; violators—you guessed it—would be subject to fines of up to $100,000 if the business is individually owned, $7.5 million if corporately owned, and/or ten years in jail.
Warrantless searches by the FDA

Under the bill, the FDA will have full authority to conduct random, warrantless searches of all records dealing with any aspect of a company’s production, manufacture, or distribution process. Under current law, the FDA only has access to records if it has “a reasonable belief that an article of food is adulterated” and presents “a threat of serious adverse health consequences or death to humans or animals.” Under the FSEA, however, the FDA has access to all records, at any time, and without any evidence whatsoever that there has been a violation. Warrantless searches are a powerful weapon of intimidation and harassment.

The bill also extends FDA’s authority to access records of a farm and restaurant—both of which are exempt from FDA’s reach under current law. Even farmers selling direct to consumers would have to provide the federal government with records on where they buy supplies, how they raise their crops, and a list of their customers.

The FSEA also gives the FDA complete control over recalls, seizures, detentions and quarantines—with no judicial oversight. For example, FSEA lowers the standard FDA must meet in order to conduct an administrative detention. Currently they must demonstrate “credible evidence” that a food presents a health threat before an administrative detention is allowed; the FSEA standard is “any reason to believe that an article of food is adulterated, misbranded, or otherwise in violation of this Act.”

Burdensome administrative requirements, including a new food tracing system
The FSEA requires all facilities, farms, and restaurants to implement new hazard analysis and risk-based preventive controls, food safety plans, and an extensive record maintenance program—again, without taking into account the differences between small facilities and large commercial facilities.

The FSEA also mandates an extensive food tracing system for all farms, or facilities that produce, process, or transport food, even if the food does not cross state lines, though at least “direct sales by farms” (i.e., sales directly to stores, restaurants, or consumers) are exempt—which means that most vendors who participate in a farmer’s market would not be affected. Each person in the production, manufacturing, processing, packing, transportation, or storage chain must “maintain the full pedigree of the origin and previous distribution history of the food” and must “establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons.”

The bill does not explain how far the traceback will extend or how it will be done for multi-ingredient foods. With all these ambiguities, it's far from clear how much it will cost either the farmers or the taxpayers. Small farms may find this trackback system costly and time-consuming.

If the FSEA passes, only big businesses and large corporate farms will matter
With FDA having such vast control, authority, and access, globalization and harmonization of food quality is a step closer. HR2749 does not make any allowances for small- to mid-sized farms or facilities, which could mean economic ruin, closure, or dependence on large corporations or foreign food supply sources.

Let’s say you’re a small organic farmer, and you have a roadside stand on your own property. If this bill passes, you would now have to follow federally established standards for growing your produce, or your food would be considered adulterated. You could not, of course, say anything about the scientific basis for organic produce being healthier than conventionally farmed produce.

Further, you would be required to make your business records available to FDA inspectors. The inspectors would have the power to show up unannounced without a warrant to search your records without any evidence whatsoever that you have committed a violation of the law. If you refuse to let the inspector see your records, you would be guilty of adulteration.

If you’re a farmer who sells products direct to consumers, you would be forced to give the FDA any customer information you have in your records. No more customer privacy. Should you refuse, you’d face up to ten years’ imprisonment. The civil fines could be up to $100,000 if you’re an individual or $7.5 million if you incorporated your family farm as a business.

There is one bright note in a rider to the bill: HR2749 at least imposes a deadline on the Secretary of Health and Human Services to notify Congress by December 31, 2009, of the final determination on the safety of BPA (Bisphenol A) in food and beverage containers.

Please take action immediately!

We need every concerned American to contact his or her congressional representatives immediately and ask that HR2749 be defeated or, at the very least, amended.

Click here to be taken to our Action Alert and contact your Representative!

1-202-224-3121 – House Switchboard

1-202-225-3121 – House Switchboard

(202) 225-0100 - Speaker of the House Pelosi

Speaker Nancy Pelosi
http://speaker.house.gov/contact or http://www.speaker.gov/contact

If the web contact form doesn't work, use this email address:
AmericanVoices@mail.house.gov

Source: American Association for Health

Posted: True Health Is True Wealth

"Control oil and you control nations; control food and you control the people." …Henry Kissenger

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Big Pharma and the FDA: Suppress the Science, Ban the Natural Substances, Sell the Drugs!

In 2005, an up-and-coming pharmaceutical company made a big mistake: they invested millions of dollars into developing a drug only to discover that the only active ingredient of the drug, pyridoxamine, was really a common, naturally occurring substance that has been sold for decades at low cost to consumers in the form of a dietary supplement, and has always been available in commonly consumed foods such as chicken and brewer’s yeast.

We’re taught as children that when you make a mistake, you should own up to it and face the consequences. Apparently the pharmaceutical company in question, Biostratum, Inc., has yet to learn that lesson. Instead of owning up to their mistake, Biostratum tried to game the system to their advantage by asking the US Food and Drug Administration (FDA) to declare supplements containing pyridoxamine “adulterated” and effectively ban anyone but Biostratum from selling pyridoxamine.

Sadly, Biostratum’s desparate ploy to save their investment worked. Earlier this year the FDA agreed to ban companies from selling pyridoxamine as a dietary supplement. They denied the request to declare products containing pyridoxamine “adulterated,” but instead they declared that such products are not dietary supplements at all—claiming they are excluded from the definition of dietary supplements under the “prior market clause” [21 U.S.C. 321(ff)(3)(B)(ii)] and so may not be marketed as such.

Please note that nowhere in the FDA’s response letter is anything said about safety concerns. In fact, the FDA’s letter specifically says that “to allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.” Fair to the pharmaceutical companies? What about fairness to consumers, some of whom rely on affordable pyridozxamine supplements to provide the levels of vitamin B-6 required for their survival? Is it fair to force those consumers to pay for expensive prescription drugs and doctors’ visits to supply their B-6 needs when they could get the exact same thing for a fraction of the cost in the form of a supplement? Isn’t this why our health care system is so ineffective?

This is hardly the first time the FDA has attacked naturally occuring substances. On October 17, 2005, the FDA banned information about the health benefits of cherries from appearing on websites—scientifically proven benefits, such as tart cherries’ ability to reduce the risk of colon cancer because of the anthocyanins and cyanidin contained in the cherry. Cherries, according to the latest research, help ease the pain of arthritis and gout; reduce risk factors for heart disease and diabetes; help regulate the body’s natural sleep patterns, aid with jet lag, prevent memory loss, and delay the aging process; and helps lower body fat and cholesterol—risk factors associated with heart disease. Moreoever, Scientists at Johns Hopkins have found that tart cherry anthocyanins reduced painful inflammation as well as a non-steroidal anti-inflammatory drug, indomethacin.

When the 2005 ban was instituted, the FDA sent warning letters to twenty-nine companies that market cherry products. In these letters, they ordered the companies to stop publicizing scientific data about cherries. According to the FDA, when cherry companies disseminate this peer-reviewed scientific information, the cherries become “unapproved new drugs” and are subject to seizure. The FDA warned that if those involved in “cherry trafficking” continue to inform consumers about these scientific studies, criminal prosecutions would ensue.

But fresh fruit and vegetables are not the FDA’s only target: As we reported in this newsletter recently, General Mills was recently issued a warning letter by the FDA for illegally marketing Cheerios Toasted Whole Grain Oat Cereal. The problem was the claim on the cereal box that Cheerios can lower cholesterol 4% in six weeks, and the statement on their website that “diets rich in whole grain foods can reduce the risk of heart disease.” The letter, dated May 5, 2009, called the above claims “serious violations” of the Federal Food, Drug, and Cosmetic Act and applicable regulations.

FDA stated that based on the claims made, Cheerios is now an unapproved drug, and must go through FDA new drug approval process.Note that the FDA isn't disputing the claim. It's disputing the company's right to make the claim.

As one newspaper columnist humorously put it, “One of these things is not like the others: morphine, penicillin, aspirin, Cheerios. Most drugs, if taken improperly, will kill the consumer or cause substantial bodily harm. An entire bottle of aspirin at one sitting will harm or kill. If Cheerios is a drug, therefore, one should be able to commit suicide by consuming the entire box.”

For years, the FDA barred health claims about the benefits of fish oil for heart, cancer, depression, body pain, and various other conditions until a drug company paid a great deal of money to go through the approval process. This type of enforcement effectively censors scientific information and greatly restricts consumer access to scientific studies that provide valuable information.

In the case of pyridoxamine, the FDA did not act out of concern for public safety. This is about money, and about a profit-seeking corporation taking advantage of what is supposed to be a public health organization in order to save their skins.

Source: American Association for Health Freedom

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Posted: True Health Is True Wealth