For nearly three days, the court proceedings in the Ontario raw-milk-rights case had been a model of Canadian civility. The judge and lawyers each referred to the other as “my friend,” rather than “colleague” or “opponent.” Opposing lawyers never once interrupted the other. The female judge always spoke in calm even tones, never admonishing the lawyers for going on too long or getting off subject. Even as they disagreed about the professional qualifications of some expert witnesses and the seriousness of data on illnesses from raw milk, the lawyers avoided raising their voices or getting personal.
It all kind of unraveled near the end of the third day, Wednesday, when the lawyer representing Canada’s Department of Justice, Joseph Cheng, in making the case against legalization of raw milk, seemed to lose his bearings. It happened while he was recounting testimony offered in advance of this week’s hearings by, of all people, John Sheehan. Yes, that John Sheehan, of U.S. Food and Drug Administration fame, America’s one-time federal milk czar (who now has the title “Senior Advisor for Compliance and Enforcement at FDA, according to his LinkedIn page).
As Cheng recalled it, Sheehan in pre-trial testimony took strong exception to data offered in a 2018 scientific paper that indicated illnesses from raw milk in the U.S. had been heading down in recent years, even as raw milk consumption was increasing. Such strong exception that he had helped draft a letter to the journal on behalf of the FDA and CDC requesting they remove the article from the journal.
Sheehan shared the letter with Cheng, who said in court Wednesday afternoon: “When I read the letter, I was kind of blown away. I had never seen anything like this….But I am not a scientist, so I asked John Sheehan during his re-examination, ‘Was the sending of this letter a normal practice?’ “No,” he said, “very extraordinary. I have been here (at the FDA) twenty years and I have never seen any request of this sort. It indicated the seriousness with which the FDA and CDC take the misrepresentations.” “
Cheng wasn’t done. He told the judge: “I don’t think this paper should be given any weight…We have foreign (American) organizations submitting evidence to change our lives,” he said, referring to Pete Kennedy, a lawyer with the Weston A. Price Foundation (and formerly head of the Farm-to-Consumer Legal Defense Fund); and Peggy Coleman, a risk analysis expert who has served on the board of the Raw Milk Institute (RAWMI). “You are being called upon to take a stand where the heads (American) public health organizations have taken a stand. I would encourage you to take a stand against it (raw milk).”
Clearly, Cheng, and likely everyone else in the court, knew nothing about John Sheehan–how during his long FDA dairy career he has refused to engage in the least bit of discussion or debate about raw milk, or even to be in the same room with raw milk proponents. Or how he refused my request for even a brief interview, and hid his career background from the media until I obtained the details via a Freedom of Information request. Or how he has made a career the last few years sending pretty much the same testimony to state legislatures any time raw milk issues come up, replete with his seeming lifelong mottos: “Drinking raw milk is like playing Russian roulette with your health,” or “Raw milk should not be consumed by anyone under any circumstances.” (Cheng had used the latter quote earlier in the day, before becoming worked up about Sheehan’s misgivings about the academic paper.)
Before Sheehan intruded himself (or before Cheng allowed him to intrude), the academic paper in question, written by Canadian researchers Joanne Whitehead and Bryony Lake in 2018, had been the subject of much attention at the hearing. The attorney representing the raw milk petitioners, Jonathan Nehmentallah, had on Tuesday argued that the paper’s data “didn’t support the thesis that increased access to raw milk leads to increased outbreaks….We’re not submitting there is causation, but there is a trend here.”
Indeed, as I reported shortly shortly after the paper was published in 2018, it made the case that the reported outbreak rate for raw milk proportional to estimated increased consumption (since no one has actual consumption data) had declined 74% since 2005.
Nehmentallah cited the paper, along with other recent research, to argue that raw milk is becoming safer, while evidence mounts that it confers important health benefits on those who regularly consume it. “While we don’t understand the exact biological mechanisms, we do know there is a protective effect.”
Cheng had spent much of Wednesday trying to build a case that raw milk hasn’t been proven to confer health benefits, and besides, is especially risky for vulnerable populations, especially children, the elderly, and pregnant women. He also used Sheehan’s raw milk obsessions to suggest that America’s raw milk regulatory approach is similar to Canada’s at the federal level, while ignoring the reality that actual practical regulation happens at the state level in the U.S., where more than 80% of states allow raw milk sales in some form. There wasn’t the slightest bit of give in Cheng’s day-long recitation–in other words, he appears to support continuing the outright Canadian ban on raw milk sale and distribution in effect since 1991.
The trial is expected to conclude on Friday.
A great review of federal lawyer Joseph Cheng’s day long diatribe against raw milk. It was disappointing for a number of reasons. In a perfect world one hopes that government has a balanced and evolving approach to an issue and not an extreme, fossilized and adversarial approach. Yes , Joseph Cheng was hyper-aggressive . I mentioned his attacks on Dr. Nadine Ijaz’s credentials which continued today, This would be a real loss for the whole country if her views were disallowed and not integrated into the new unpasteurized dairy regulatory scheme we need to envision and cocreate as soon as possible.
At one point the judge asked him about farmgate only sales that some US states allow. The Judge asked, ” is not that somehow safer” ? Lawyer Cheng replied ,”Well i don’t want to be seen to be given testimony or evidence for the other side”. But then he grudgingly replied that ,”Yes, when the milk is fresher and has been handled less in a farmgate sales situation , and travelled less, that the bad bacteria would have less time to grow and multiply”.
If you listened very hard and could stomach all the negativity, half truths and distortions from the whole day, he surprisingly did at the very end volunteer a constitutional perspective of what it would look like if the honourable judge ruled that it was time to suspend the prohibition in Canada. He said that in the event of a decision, based on Section 2 or 15 of the Canadian Charter of Rights and Freedoms, to end the prohibition against raw milk sales, the federal government should be given 2 years to work on developing the new regulatory scheme due to its complexity. In the interim, the REMEDY for a Section 2 or 15 claims in the Charter is a SEction 52 declaration by the judge. In that the the Canadian parliament in cooperation with the 10 provinces should be given 24 months to come up with their own plan first before a judge intervenes further. Parliament must be given a chance to respond FIRST.
In the interim a standalone exemption could be granted to Glencolton Farms for 2 years more to produce and distribute raw milk, as they please, to its coop members (we only wish ! ) from Section 24. So there would need to be an exemption and a declaration. The Supreme Court generally avoids standalone exemptions. Section 52 comes into play if the judge determines that the prohibition law on raw milk is no longer justified.
As said we still need to give the governing parties (i.e parliament in Ottawa and provinces) a chance to develop the new and complex regulatory schemes and these things take time and lots of work .
MAYBE JUST MAYBE THIS WAS A GLIMMER OF HOPE OR A CONCESSION FROM THE FEDERAL GOVERNMENT’S SIDE AT LEAST THAT THEY ARE OPEN TO THE POSSIBILITY FINALLY , AND HOWEVER GRUDGINGLY, OF CHANGE. Unfortunately , we would have to wait until Thursday to see what the ONTARIO provincial lawyers say and if they are consistent with this line of thinking .
He, Lawyer Padraic Ryan may or may not be so inclined, so please withhold your celebrations !
Raoul, thanks for the supplemental information. I must have missed the judge’s inquiry about farm-based sales. And I can’t pretend to be familiar with the inclinations of Canada’s Supreme Court.
the federal government has no say in regulation of raw milk as food : it’s a provincial power. As a drug, OK. Otherwise, the Feds can get stuffed. Unless I ship milk out of the country – such as butter to Japan, or into the US of A – it’s not the business of the federal bureaucracy.
I go back so far I remember the Canadian Wheat Board. Another one of the cartels in the Fabian Progressive Economic Program. For most of my lifetime, it was UN-thinkable that its monopoly would ever end. But it did
several farmers drove across the border and sold wheat grown on their farm, to US buyers. Illegal north of the 49th parallel… so they went to gaol in Canada.
A couple of years later, when he’d put the Cdn Wheat Board in its place, Prime Minister Stephen Harper went to a BBQ at the home of one of those guys and pronounced “These men were not criminals” direct quote
Same thing will happen with the Cdn Dairy Commission
what this silly Ontario Justice sez is irrelevant to producing REAL MILK in British Columbia for people who own a beneficial interest in the herd
Gordon: If the Canadian federal government opens up on removing raw milk prohibition and finally allowing raw milk sales and distribution, I think that would be good for BC. If anything that would be a greenlight for BC to go it alone and do it right and as the local small organic BC dairy farmers would like. In such a situation, I would expect a checkerboard situation across Canada, with BC and Quebec leading the way and allowing retail unpasteurised milk sales in stores, via farmgate, or in private coops or herdshares finally, again after 30 or 80 years. In between you might have a few provinces that allow herdshares or farmgate sales only like in Saskatchewan or some others. And at the bottom of the barrel you might find provinces like Alberta and Ontario ( I hope not) still banning it altogether.
There is a cold place in hell for John Sheehan. He denies the very existence of his own CDC and NIH peer reviewed and Pubmed published literature and science.
It’s truly an outrage. The massive amount of pressure that the FDA uses to oppress raw milk is a directive from their bed buddies in the processing industry.
He could care less about the proven health benefits of safe raw milk. Consumers health means little to the FDA or Sheehan.
It is truly upsetting.
At present our lawsuit against the FDA to force legalization for raw butter sales over state lines sits before a judge in the federal courts. Our science and legal authorities are powerful.
True justice will be served soon… I quietly pray.
I think we need to ask ourselves what implications this “Grand Reset’ will have on our right to consume raw milk… The Liberal Prime Minister of Canada stated in a speech to the United Nations, “This pandemic has provided an OPPORTUNITY for a RESET. This is our CHANCE to accelerate our pre-pandemic efforts to REIMAGINE economic systems.” Indeed, and the American people can expect this same top down utopian idealistic thrust if the left assumes power in the United States. Trudeau and the Liberal Government’s decision to mobilize the military to help administer Covid vaccines is but one example and speaks volumes of this plan to move towards a grand reset… The collectivist-based Milk Marketing Board system in Canada was established and granted its overbearing status by government decree and there is a joint effort between the marketing boards and the food safety and inspection bureaucrats to maintain that status. What we currently see happening via these Covid lockdown and mask wearing narrative etc. is a power grab with the fear of a microbe (germaphobia) being used as a tool to achieve that objective… and so it is with this attempt by the likes of John Sheehan in the US and the marketing board system in Canada to obstruct the sale of raw milk… It is a growing and increasingly transparent narrative that is destined to erode fundamental liberty.
Do me a favor, Ken, and don’t try to equate the struggle over raw milk with the current struggle over whether “the left assumes power in the U.S.” You give away your autocratic inclinations. The struggle over raw milk has proceeded in fits and starts for decades, regardless of political party. If and when Joe Biden takes the oath of office on Jan. 20, it will be because he was elected by a large majority of Americans. If he fails to be inaugurated, it will be because of a coup initiated by Trump and the Republicans, pure and simple, and any “grand reset” will be the least of our problems.
Here is an op-ed piece I wrote a few days ago about the ongoing American struggle, and what repercussions a serious coup effort might trigger.
yesterday, I had someone in England place a $100 US bet for me that Donald Trump will be the next President ; odds 44 / 5 against. So the payout will be $880.
My offer still stands on this forum : I offer a genuine pre ’66 US silver dollar versus one red cent, that … one way or another ….Mr Biden will not make it to the finish line = and let’s be sure we all admit that’s Jan 21 2021 … NOT what the LugenPress would have you believe. A week can be a lifetime in politics
Talk is cheap (as are predictions). I can’t keep track of all your predictions and conspiracies, but I do recall you were predicting at one point that Trump would be reelected in a landslide and it would be Trump Uber Alles for many years. Really not a productive discussion.
Jeepers … I’m offering 100 to one and no takers? You guys aren’t nearly all that confident in what the LugenPress sez, after all !!
prior to KronaMadness, I would’ve said = “you oughta get out of the house more often” Mr Gumpert … so as to get the facts that a real journalist has to have. You should’ve tuned-in to the President’s conference today wherein he detailed how the frauds were carried out. Especially, how his Executive Order of 2018 pertaining to interference in the electoral process by outside influences = in this instance, the offshore corporation running the machinery for the US election, criminal-ized everyone who touched the travesty of what happened on November third 2020
As farfetched as it is for you to comprehend … in your Eastern Establishment Echochamber … Donald Trump did in fact ‘win by a landslide’. you owe to thyself to hear what federal prosecutor Sidney Powell has to say
yes, the Big Lie was halfway ’round the world, for a week. But the Truth now has her boots on. And she is going to stomp them all over Biden et al.
I agree with you that going on about the disgrace of November 3, does not edify re REAL MILK… but since you are floundering-around with one foot nailed to the floor on this Biden thing … I’m offering more and better information to help you come to terms with the world as it really is
Yes, political parties of all persuasions have capitulated and have chosen to enforce policies limiting and/or banning the sale of raw milk. That said, in Canada, the three mainstream political parties have increasingly adopted socialist policies… The socialist NDP party being the furthest left, the Liberal party becoming virtually indistinguishable from the NDP and the “Progressive” Conservative Party assuming what used to be the moderate role of the Liberal Party from the 50’s 60’s and 70’s. The overall result of this transformation in the Canadian political environment has been the erosion of private property rights and individual liberty. Apart from my longstanding support of raw milk consumption and my adoption of organic farming principals in the early 1980’s; I’ve also been a proponent of environmental practices… but not at the behest of the government’s buggered up organic and environmental regulations that have served to do little more than systematically assault and reduce the number of small family farm operations.
I truly hope that this constitutional challenge will be successful in its endeavor to attain the right for Canadians to purchase and consume raw milk… I am not about to hold my breath however waiting for that to happen, especially considering the current antagonistic and controlling attitude towards microbes including the attempt to take advantage of that attitude to implement a “grand rest”. This pursuit of a “grand reset” at the expense of liberty is the basis of our problems…
Your suggestion that I have autocratic inclinations is laughable… I would point out rather that anyone that supports the following narrative certainly appears to have given away their autocratic inclinations…
“Red Zones, the facemask, social distancing, the closing down of schools, colleges and universities, no more family gatherings, no birthday celebrations, music, the arts: no more cultural events, sport events are suspended, no more weddings, “love and life” is banned outright.”
“And in several countries, Christmas is on hold …
“It’s the destruction of people’s lives. It is the destabilization of civil society. And for What?
“The Lies are sustained by a massive media disinformation campaign. 24/7, Incessant and repetitive “Covid alerts” for the last ten months. … It is a process of social engineering.”
I had the privilege of having Dr. Ijaz as a teacher when I studied at The Canadian School of Natural Nutrition. She is an excellent educator. I am grateful that she is on our side. Thank you Dr. Ijaz!!!
David, you should censor statements that are not adressing the topic of your article.
Friday update: Farm lawyer’s Nementallah argument can be summed up this way :
1. There are numerous benefits to organic properly produced raw milk (to the highest standards of hygiene and animal husbandry)
2. The risks can and are mitigated again with proper systems in place for health of the animal and hygiene of the farm and cold chain management
3. The risks are “De MINIMIS” (negligible ) again when compared to other foods like (lettuce, turkey, oysters, chicken or eggs) and when compared to the rest of the world where 99% of the countries already allow and regulate safe raw milk for productin, sale and distribution.
4. The arguments of the Ontario government, municipality of York Region, Federal government and DFO/ DFC consistenly rely on old research from between 11 and 80 years and have never evolved along with the rest of the world. They are especially deficient in the advancing field of QMRA risk analysis of which only Expert Peggy Coleman has training and was able to provide coherent evidence, affidavits explanation on .
I would add they are absent any mention of the importance of technology that RAWM trained farmers are now able to use to test all their cows onsite and within a few hours every single day. Thus negating the need for expensive weekly visits of veterinarians as in the German Verzug milch system.
First rule of dirty politics. Deny the existence of anything good on the other side
In other words. A healthy dose of denial. RAWMI is a very inconvenient truth
For the next court case, I hope the following points will be address which were lacking : for some people pasteurized milk is not healthy and can make them sick or slowly deteriorate their health – by lowering their bone density, creating diseases like Crohn’s Disease or Colitis, IBS, increase tooth decay because the enzyme Phosphatase is deactivated therefore the calcium is not absorbed, and explain what each of all the other enzymes do to increase good health, explain how asthma and allergies is reduced by children that do not have the ‘association’ of living on the farm, why at the start of the Medical Milk Commission raw milk was used for hospitals for the patients health to improve and also that the Mayo Foundation used grass-fed cow’s milk to cure many things like TB. To continue on the big one of Milk Intolerance which is suffered by approximately 20% of consumers getting sick enough times when they consume unpasteurized milk that they avoid milk until they take a chance to consume raw milk with no ill symptoms that they previously had. The reason being that the enzyme ‘lactase’ is not deactivated in raw milk as it is when milk is pasteurized.
the 2nd to last sentence should read
To continue on the big one of Milk Intolerance which is suffered by approximately 20% of consumers getting sick enough times when they consume PASTEURIZED milk that they avoid milk until they take a chance to consume raw milk with no ill symptoms that they previously had.
Thank you Gordon, I appreciate your correction.
To emphasize the point that raw milk is needed by some, the court case that took place in Edmonton, the Judge’s final decision was to allow the parents of a child to pick up from the farm, raw milk, because the child’s health improved with raw milk but had deteriorated previously with pasteurized milk. This is a precedent setting case that is an exception that is not set by Parliament because it can not be govern by Regulations, therefore it is usually not allowed.
Another case is by True Hope where the Judge ruled that if True Hope obeyed Health Canada’s Cease and Desist Order and a person died because the Order was obeyed that Health Canada could be charge to contributing to the death. Likewise, if a person dies of asthma because they could not access raw milk, the parents, spouse, etc. may hold Health Canada Liable because Health Canada prohibits the access of raw milk when a person can not afford the land, cows, and does not have the education to keep and milk a cow.
The Ban on Raw Milk does not encourage the on farm communication between neighbours and city people with the farmer that holds the Teat that they can trust. The consumer should access to the farm on a personal basis more often than just a once a year Farm Tour to increase their immunity as argued by Health Authorities in the European Asthma Research regarding association of the children on farms. The Quota holders (DFC) can not take risks because their cows are not as healthy as cows that are grass-fed, low producing, and their feed is more organic, therefore, the milk has less toxins in it. ‘Toxins in milk’ is not accepted by the Dairy Farmers or Health Canada because it is so minute and hard to prove but Toxins do affect some people. That is why some people can not drink store milk when they are in the States.
Richard B. : Thank you for the reference about the Edmonton raw dairy that was given a supposed exemption to supply a child. I could not find any information about this case in the Alberta Courts in 2011 ?
Regardless the farmer Judith Johnson was still fined a $1000 which, while not exhorbitant, is not exactly a ‘free pass’ or a license to do as you please!
So I don’t think this case law would have been useful in any case for last weeks court hearing in Ontario. I mean a court order (to supply the child with her raw dairy needs) with NO FINE might have been useful. But since she was still punished (and i may never know the details) it is probably not useful.
Anyways, at least we now have the link from The Bovine blog for Canadian Raw milk drinkers :
Thank you for your great and relevant points.
The Farms legal team did a wonderful job of preparing their Factum. I think all the submissions from both sides total 18 000 pages.
I have no way of knowing if the True Hope was included as a Case Law reference (R. v. Synergy Group of Canada Inc., 2006 ABPC 196 (CanLII) ) but certainly it was one of the most groundbreaking cases, for the causes related to natural health methods, in the history of Canada.
This is from True Hope’s own website ;
“Health Canada insisted that the Defendants [Truehope]…stop selling and distributing EMPowerplus to the thousands of participants in the Truehope program in Canada.”
“Since the Defendants made claims that EMPowerplus was useful for the treatment of depression and bi-polar disorder, Health Canada took the position that this brought the micronutrient treatment within the definition of a “drug” within the meaning of the Food and Drugs Act, even though the product was clearly a vitamin/mineral micronutrient treatment.”
“Health Canada advised the Defendants that they could not sell or distribute the micronutrient treatment in Canada without a Drug Identification Number or “D.I.N.”. However…it would not be possible for the Defendants to obtain…a D.I.N. for EMPowerplus, and Health Canada was well aware of this fact.”
“Fearing for the health, safety and well-being of their participants in the Truehope support program, the Defendants continued to take orders for the micronutrient treatment, transmit the orders to their manufacturer in the United States, and distribute the micronutrient treatment in Canada.”
Evidence from Expert Witnesses
“the significant results of treating depression and bi-polar disorder with vitamin/mineral micronutrient treatment rather than conventional pharmaceuticals attracted interest from…experts in the field of treatment of depression and bi-polar disorder in Canada and the United States.”
“Dr. Charles Popper, a psychiatrist at Harvard University, who also teaches psychiatry to other psychiatrists, testified that…if the micronutrient treatment [EMPowerplus] became unavailable, symptoms associated with depression and bi-polar disorder…would return.”
“Dr. Popper has most impressive qualifications. Although he was initially extremely skeptical with regards to the micronutrient treatment, by the time of trial approximately 100 to 150 of his patients were using the micronutrient treatment… In addition to his patients, Dr. Popper testified to having consulted on 300 to 500 additional patients on the micronutrient treatment.”
“Dr. Charles Popper…testified that if the micronutrient treatment became unavailable there would be aggressive behaviour, assaults, hospitalizations, incarcerations and suicides. He testified that his patients would have to be returned to medications which lack stability and had negative side-effects. Overall, Dr. Popper testified that he would not be able to manage his practice at the level to which it had grown and he would have to refer patients away from his practice.”
“The expert evidence before the Court with regards to the objective harm that could occur included the observations of Dr. Bonnie Kaplan, a psychologist from the University of Calgary, who observed the rapid return of symptoms once the micronutrient treatment was discontinued”.
“The expert evidence of Mr. Dales, consultant, with regards to the classification of substances and the approval process under the Food and Drugs Act and Regulations was that the process for the approval of a new drug through the Therapeutic Products Directorate of Health Canada, was a process which would take several years and cost millions of dollars. In the end, Mr. Dales evidence was that it would have been impossible to obtain a D.I.N. for this vitamin/mineral micronutrient treatment because of the nature of the product as a health food product with multiple ingredients going through a therapeutic drug testing regime which typically tested products with only one or two ingredients.”
Evidence from Other Witnesses
“the evidence of numerous witnesses called by the Defendants [Truehope] on the effects of the micronutrient treatment [EMPowerplus] on their lives or on the lives of their family members…was compelling and persuasive.”
“If an individual stopped taking, or was denied access to the micronutrient treatment, that person would revert within a matter of days to an earlier state of depression or bi-polar behaviour characterized by aggressiveness, mood swings, and violence to one’s self or to others with a very real risk of personal injury and, in some cases, death.”
“the evidence of Sabine Colson, Autumn Stringam, Debra Oxby and Sheila Stanley [was] based on their personal experiences or observations of close family members regarding how depression and bi-polar behaviour rapidly returned when the micronutrient treatment was not taken.”
“Ms. Colson described self-inflicted injuries, being involuntarily committed, and becoming useless to the point where she had formulated a plan to kill herself before she lost her mental health again.”
“Ms. Oxby described the harm as having to hear her son beg her to kill him several times a day and watching her son deteriorate as he lost his mental health, his friends, his self- esteem, his dignity and his will to live.”
“Ms. Stanley expressed similar concerns with regards to her daughter and her husband.”
“Ms. Stringam described her severe incapacitation prior to the micronutrient treatment and was fearful and concerned that without the micronutrient treatment she would not be able to care for her children and her family and that she could not go out in public for fear of her behaviour. She feared being medicated and consumed with drugs, and becoming suicidal and hospitalized.”
“Ron LaJeunesse, the Alberta head of the Canadian Mental Health Association, was very knowledgeable of the risks facing persons with mental illnesses. He expressed grave concern for the conduct of Health Canada in preventing the micronutrient treatment from coming into this country. He testified that death was a consequence of bi-polar disorder and that he was concerned that there would be suicides if individuals could not get access to the micronutrient treatment.”
“Dr. Lunney, a Member of Parliament, attempted to intervene on behalf of the Defendants to obtain a meeting with the Minister [of Health].”
“The Defendants [Truehope] are NOT guilty”
“The Defendants were overwhelmingly compelled to disobey the D.I.N. regulation in order to protect the health, safety and well-being of the users of the micronutrient treatment [EMPowerplus] and the support program.”
“…thousands of individuals who had found relief from mental illness through the micronutrient treatment [EMPowerplus] without the negative side effects of conventional medications were relying upon them [Truehope] to continue to sell and distribute their product and to maintain the Truehope program.”
“…the Defendants were under a duty or duties described in [Section] 216 and 217 of the Criminal Code of Canada to continue to provide the vitamin/mineral micronutrient treatment and to maintain the support program or possibly face the consequences of being charged with criminal negligence.”
“The Defendants took all reasonable care that could have been expected of a reasonable person in the circumstances to comply with the requirements of Health Canada under the Food and Drugs Act and Regulations.”