NWV News - Senate Votes to Boost FDA Police Powers With GOP Help

SENATE VOTES TO BOOST FDA POLICE POWERS WITH GOP HELP

By Sarah Foster
Posted 1:00 AM Eastern
May 21, 2011
© 2011 NewsWithViews.com

Senate Passes Stealth Food-Safety Crime Bill

WASHINGTON – Republican senators joined Democrats last month in passing an under-the-radar measure, authored by Sen. Patrick Leahy (D-Vt.), to add more “teeth” to existing food law.

On April 14, as Congress prepared to adjourn for a two-week recess, the Senate quietly approved S. 216: The Food Safety Accountability Act of 2011, legislation that would expand the reach of the Food and Drug Administration over food shipped across state lines, by enabling federal prosecutors to seek steep fines and 10-year sentences for certain violations of the Food, Drug, and Cosmetic Act (FD&C Act) that are currently simply misdemeanors.

Introduced Jan. 27, S. 216 is a replay from the previous congressional session, similar language having been included in the Food Safety Enhancement Act that the House passed in July 2009 but which failed to advance in the Senate.

Recognizing it as a threat to producers of natural foods and dietary supplements, health freedom advocates rallied public opposition and lobbied successfully to prevent its passage last year as a stand-alone bill (introduced by Leahy in September) and from being attached to the FDA Food Safety Modernization Act (FSMA) that Congress passed in December.

Now it is back.

As with the FSMA, passage was “by consent,” meaning there was no debate, no objections, no roll call, and the voice vote was recorded as unanimous. The following day the bill was referred to the House.

In a statement Leahy touted S. 216 as “an important bill to hold criminals who poison our food supply accountable for their crimes.”

He thanked the six Democratic co-sponsors for their support and commended his colleagues across the aisle for standing aside. Although no Republican had signed on as a co-sponsor, none raised a word of protest. Leahy singled out for special notice GOP senators Tom Coburn (Okla.), Chuck Grassley (Iowa), Orrin Hatch (Utah), and Jeff Sessions (Ala.), all of whom sit on the Senate Judiciary Committee which Leahy chairs.

Those senators “had concerns about the breadth of the bill, and we were able to work together to address those concerns,” Leahy said, noting, “The bill received unanimous, bipartisan support when it was reported out of the Judiciary Committee [on March 31], and I am pleased that it has now received similar support from the Senate.”

Leahy did not say what it took to calm the concerns of Hatch and Coburn, but long-time opponents remain unconvinced of the measure’s benefits. The advocacy group Alliance for Natural Health-USA warns:

[S. 216] contains language that is open to interpretation. While intended to protect the public from food manufacturers who would harm the public with their negligence, the vague language may also be used by the FDA to attack innocent natural health food and dietary supplement producers.

S. 216 is a very short measure, “A bill to increase penalties for certain knowing and intentional violations relating to food that is misbranded or adulterated.”

Specifically, it amends the Food, Drug, and Cosmetic Act by adding a couple of new phrases to Section 301, under Criminal Penalties:

(3) Any person who violates subsection (a), (b), (c), or (k) of section 301 with respect to any food – (A) knowingly and intentionally to defraud or mislead; and (B) with conscious or reckless disregard of a risk of death or serious bodily injury, shall be fined under title 18, United States Code, imprisoned for not more than 10 years, or both.

That’s basically it. But there’s a lot packed in there according to those contacted by NewsWithViews who are familiar with the bill and FDA policies in interpreting and enforcing existing laws.

A “Blank Check” for the FDA

Darrell Rogers, communications director for the ANH-USA, said one reason for concern is it that the bill amends the FD&C Act, and the FDA tends to regard any modification to the FD&C Act as “kind of a blank check for them.”

He said that although some changes have been made to last session’s versions so it has “fewer teeth,” the language is still too vague and open to interpretation, particularly the words “adulterated” and “misbranded.”

These words don’t mean the same to the FDA as they do to the general public Rogers explained. “Adulterated” isn’t always synonymous with tainted or contaminated; and “misbranded” doesn’t necessarily mean false or misleading.

“To the FDA, a food or supplement may be ‘adulterated’ if some vague FDA rule is deemed by the FDA not to have been followed, and that includes record-keeping violations,” he said. “’Misbranded’ can mean that a producer makes a completely true statement about the product but without FDA permission.”

Rogers was referring to the FDA policy of targeting food and supplement companies that promote their products by citing or linking to peer-reviewed articles in scientific journals. To the FDA these constitute “unauthorized health claims” and are considered a form of “misbranding” because the product (be it a fruit, vegetable, nutrient, or other ingestible) is by FDA interpretation an “unapproved drug” when promoted as a way to treat, mitigate or prevent a disease.

Then there’s the question of whether the new law does or should apply to dietary supplements as well as to food.

“Supplements are regulated as food, but defined differently,” said Rogers, “So we want to be sure the law addresses food safety and that the FDA knows it’s for foods that are obviously tainted with things like salmonella, and is not used to threaten supplement companies.”

As with food companies, if a supplement company on its website links to a medical study about the benefits of a nutrient or an herb, the FDA can send a letter saying the product is misbranded and could be subject to confiscation.

“The last thing we want the FDA to be able to do is write threatening letters to supplement companies saying ‘Because you linked to a scientific study on your website you could face 10 years because of this new bill.’”

“That’s our concern. We’ve seen them do things like that before.”

To prevent abuses of that kind ANH-USA wants language in the bill that specifically exempts supplements from its provisions, and carves out certain exemptions in the definition of misbranding and adulteration or redefines those terms.

“Invites Mischief”

Constitutional attorney and NWV columnist Jonathan Emord has won seven major lawsuits against the FDA and written extensively about the agency’s on-going effort to put supplement manufacturers and food producers out of business.

Not one to mince words, Emord has slammed the FDA as “a rogue whose leaders view themselves as above the law and unaccountable to the courts and Congress, … a government unto itself, refusing to respect limits on its power contained in its enabling statute and in the Constitution.”

In talking with NWV Emord drew attention to the phrase “with conscious or reckless disregard” – which he said “invites mischief” and could be used by the FDA “to go after anybody they wanted.”

“Any deviation from the Good Manufacturing Practices regulations could be said to be a basis for a finding of reckless disregard,” he explained. And although the bill does not specifically mention vitamins or supplements, because these are already regulated as food they would come under the provisions of the act unless the text expressly excludes them, which at present it does not.

As Emord sees it, “The problem with [S. 216] is that it enables the FDA to attack parties predicated upon a determination that a food product or a dietary supplement is unsafe, without the necessity of proving an intent to cause harm. That’s a real problem. They have ‘knowing’ and ‘intentional’ in (A), but (B) says ‘conscious or reckless disregard of a risk’ – that invites mischief because the agency can determine that someone who didn’t satisfy the 1,000-plus pages of detailed regulation on the process of making a dietary supplement engaged in reckless disregard of the requirements.”

“[S. 216] broadens the scope of people they usually can go after and increases the penalty,” he said. “You can be fined under Title 18 [the U.S. Criminal Code] or imprisoned or both, and imprisonment can be for 10 years -- that’s 10 years for each alleged offense.”

“So you can multiply that 10 years many times, because in most cases where there is an argument that someone is engaged in adulteration you can find multiple instances of distribution of an adulterated product, and then you can attach 10 years to each instance,” he said.

“This is Not About Poisoning”

At the D.C.-based Heritage Foundation, attorney Brian Walsh, senior legal researcher, edits the website www.overcriminalized.com to publicize the trend in America – particularly in Congress – “to use the criminal law to ‘solve’ every problem, punish every mistake (instead of making proper use of civil penalties), and coerce Americans into conforming their behavior to satisfy social engineering objectives.”

Walsh recently posted details about S. 216 online.

In commenting on the bill to NWV, Walsh said that while “it may be appropriate to have civil penalties for extremely broad offenses that include all kinds of potential misconduct and just flat-out mistakes, it’s generally improper to have criminal penalties associated with those – especially this draconian 10-year criminal penalty that goes along with this.”

“Vague, overly broad criminal provisions such as these warrant far closer scrutiny and debate than this one was given by the Senate,” he said.

Walsh predicted that “Because there is already existing law that criminalizes any type of intentional poisoning of food, I think the net effect of this law will not be to protect the public but to expand government control over all kinds of food production.”

And he took exception to Leahy’s indication that S. 216 was needed to bring food poisoners to justice.

“[S. 216] is not about poisoning the food supply, despite what Sen. Leahy said in his speech. It’s already a crime to poison the food supply,” he declared.

“This is really about mistakes that may be made in the production of food and the definition of what it means for a food to be ‘misbranded’ or ‘adulterated.’ Those terms are so broad that they could encompass lots of very unintentional misconduct and yet subject individuals to 10 years in prison.”

Walsh suggested that one way to “fix the problems” would be to put in “far more protective criminal intent language that used the word ‘willfully,’ instead of the more nebulous words ‘intentionally’ and ‘knowingly.’”

“’Willfully,’ requires the government to prove that the individual knew that his conduct was unlawful or knew that it was inherently wrongful. Obviously, poisoning something would fall into that category,” he said. “The best way to do it would be to put ‘willfully’ and ‘knowingly’ together. ’Knowingly’ and ‘intentionally’ is not nearly as protective and doesn’t protect innocent Americans anywhere near the degree that ‘willfully’ does.”

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STATUS: S. 216 has been assigned to the House Judiciary Committee and the House Energy and Commerce Committee, but there’s been no further action. Darrell Rogers says the House could introduce its own version at any time or take up the Senate version. ANH-USA has opened a webpage for activists to Take action now to ensure the House doesn’t introduce and pass a similar bill!

Rogers fears that because S. 216 moved so quickly through the Senate the public may not realize how dangerous it could be and it will be difficult to rally opposition.

“We have to make sure people know it’s controversial,” he said.

Selected Earlier Stories

1 - Jonathan Emord: FDA Tyrannizes Amish Farmer: May 17, 2011
2 - Jonathan Emord: FDA Destruction of Dietary Supplement Industry: April 4, 2011
3 - Sarah Foster: Senate Republicans Join Democrats to Pass Food "Safety" Bill: Dec. 20, 2010
4 - Sarah Foster: Dems Pull Fast One with Food-Safety Bill: Dec. 10, 2010
5 - Sarah Foster: Whoops! Food-Safety Bill Hits Constitutional Snag: Dec. 2, 2010
6 - Jonathan Emord: FDA Hypocrisy: Dec. 6, 2010
7 - Sarah Foster: House Set to Vote on Fast-Tracked "Food Safety" Bill: July 30, 2009

Additional Articles and Information

1 - S. 216: The Food Safety Accountability Act of 2011
2 - U.S. Code: Title 21: Food and Drugs
3 - USC 21, Chapter 9: Federal Food, Drug and Cosmetic Act
4 - S. 510: The FDA Food Safety Modernization Act: passed Dec. 20, 2010, with new number: H.R. 2751
5 - Leahy Bill Passes in Senate--Help Us Stop It in the House! Alliance for Natural Health-USA, April 19, 2011
6 - Urgent Action Alert: The Leahy Bill is Back! ANH-USA, April 12, 2011
7 - The "Food Safety" Saga: Our Job is Just Beginning: ANH-USA, Jan. 4, 2011 Contains an excellent timeline of the “Food Safety” bills from the House versions (H.R. 875 and H.R. 2749) to the Senate (S. 510).
8 - Both House and Senate Vote Yes on Food Safety Bill: ANH-USA, Dec. 21, 2010
9 - Please Help Us Stop the Leahy Food Safety Bill: ANH-USA, Nov. 16, 2010
10 - What is Happening with the Leahy Bill? A New Action Alert: ANH-USA, Sept. 28, 2010