An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology E-Book
Alessandro Stasi
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- Herausgeber: Bentham Science Publishers
- Kategorie: Fachliteratur
- Sprache: Englisch
- Veröffentlichungsjahr: 2008
Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented several measures to generate a homegrown biotechnology sector and help science-based companies develop.
This book covers some of the most important legal issues arising in relation to biotechnology. Topics covered in chapters include 1) the historical development of a legal framework sufficient to protect public safety, 2) the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology (namely the FDA, USDA and EPA), 3) the regulation of human genome editing and its impact on health research, 4) law and emerging genome editing technologies from recombinant DNA technology to CRISPR/Cas9 editing, 5) the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and 6) legal issues arising from the use of genetic engineered plants and animals. The authors have ensured that the contents are easy to understand, making this an accessible reference for a broad range of readers.
This book, therefore, serves as a quick summary of the prominent legal and regulatory issues in the biotech industry for professionals, as well as scholars in legal study programs.
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PREFACE
Technology is a useful servant but a dangerous master.
Christian Lous Lange, Historian
Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented a number of measures to generate a homegrown biotechnology sector and help science-based companies develop.
The chapters cover a multitude of themes and some of the most important legal issues arising in relation to biotechnology, including the historical development of a legal framework sufficient to protect public safety (Chapter 1), the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology, namely the U.S. Food and Drug Administration, the U.S. Department of Agriculture, and the U.S. Environmental Protection Agency (Chapter 2), the regulation of human genome editing and its the impact on health research (Chapter 3), law and emerging genome editing technologies from recombinant DNA to CRISPR/Cas9 (Chapter 4), the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research (Chapter 5), and legal issues arising from the use of genetic engineered plants and animals (Chapter 6).
CONSENT FOR PUBLICATION
Not applicable.
CONFLICT OF INTEREST
The author confirms that he has no conflict of interest to declare for this publication.
ACKOWNOLEDGEMENTS
Thanks to Dr. Alexei Blanc, Dr. Nazim Foury, Dr. Pantitcha Maluleem, Dr. Thitirat Witoonchart, Dr. Donatella De Ruggiero, Dr. Sergio De Ruggiero, and Dr. Mike Sunstein for their assistance in preparing the manuscript for publication. Also, I am grateful to Prof. Eugene Ackerman, Prof. Cass Balkin, Prof. Susan Kagan, Prof. Richard Stone and Prof Daniel Dorf for meticulously reviewing the entire text several times and offering valuable suggestions. Many thanks to the numerous academics who helped me with my research, especially John Miles, Robert Stroud, Angela Remondo, Alex Megram, and Rosalind Cook. I want to extend my thanks to Mahidol University International College, the University of Naples Federico II, the Faculty of Law, the Sapienza University of Rome, and the many students who have contributed to the work. And a very special thank you to Alhena and Davide.
The History of Biotechnology and the Law
Alessandro Stasi,Tan Weng Chiang DavidAbstract
The chapter explores the historical development of a legal framework for biotechnology regulation. It aims to provide an overview of the history of biotechnological practices and the development of modern concepts. It describes how people had used biotechnology processes for millennia, noting that the rise of modern medicine can only be traced back to the 19th century, when the progress of science and the advances in laboratory techniques contributed to the creation of a medical market. The chapter ends by analyzing the origins of the U.S. Food and Drugs Administration and the Food and Drugs Act of 1906.
INTRODUCTION
The beginning of biotechnology dates back to the Paleolithic era, when mankind became able to manipulate the genetic makeup of organisms in agriculture and food production through selective breeding and domestication of animals, the cultivation of crops and fermentation techniques to produce products, such as beer, wine, bread, cheese and yogurt [1]. “The most primitive type of biotechnology is the cultivation of plants and the training (in particular the domestication) of animals. The domestication of animals stretches back over 10, 000 years, when our ancestors also started maintaining plants as a reliable source of food. The earliest examples of such domesticated plants are rice, barley and wheat. Wild animals were also controlled to produce milk or meat. The ancient production of cheese, yogurt and bread from micro-organisms is also reported. Various alcoholic drinks, such as beer and wine, were developed during this period, when the process of fermentation was first discovered. Later, it was discovered that micro-organisms, e.g., bacteria, yeast or molds, hydrolyze sugars when they lack oxygen and are ultimately responsible for fermentation. This process results in the formation of products (food and drink). Consequently, fermentation was perhaps first explored by chance, since, in earlier times, nobody knew how it worked. During the prehistoric era, some civilizations considered fermentation to be a gift from their gods [2].”
Starting from BC 300 to 400, Greek philosophers became curious about human inheritance and the nature of reproduction. Plato, for instance, argued that inborn characteristics are inherited from both parents. His pupil, Aristotle, authored a number of well-known books where he stated that “children are born resembling their parents in respect not only of congenital characteristics but also of acquired ones. Moreover, this resemblance is true not only of inherited but also of acquired characters. For it has happened that the children of parents who bore scars are also scarred in the same way in the same place. In Chalcedon, for example, a man who had been branded on the arm had a child who showed the same brand letter, though it was not so distinctly marked and had become blurred [3].”
Hindu philosophers also contemplated the mechanism of human inheritance and hereditary characters. They noted that particular diseases might run in families, and children inherit their parents’ characteristics. Rooted in these beliefs, the law of Manu says that “a man of base descents can never escape his origins”.
The Middle Ages, a period that ranges from approximately 500 to 1500, “can be considered the dark age of biotechnology and law. Spontaneous generation remained the dominant explanation of the origin of living organisms, such as maggots originating from horsehair. A vinegar manufacturing operation in Orleans in the 1500s was the next development, marking an end to the dark ages of biotechnology development in Europe.
Around AD 1630, William Harvey concluded that sexual reproduction existed in the lower organisms and that males contribute sperm and females contribute an egg in the process. Harvey's discovery that sexual reproduction existed in lower organisms was a major breakthrough in the field of biology. His discovery helped to pave the way for future discoveries about the reproductive process and the role of males and females in reproduction. In AD 1665, Robert Hooke observed the cellular structure of cork, and in the same period, the idea of spontaneous generation was disproven by the work of Francesco Redi, who, with a simple experiment, showed that maggots arose from uncovered meat, while covered meat did not reproduce maggots. Then in AD 1680, Leeuwenhoek observed the fermentation process of yeast through his first microscope.
Prior to the use of cowpox, the Moravians, a religious sect in North Carolina in the early 1700s, recorded in their detailed diaries the use of a small infection of smallpox to guard against a more serious case. This often resulted in death from an expectedly serious case. It was not until 1797, that Edward Jenner used a different living organism (cowpox) to protect people from diseases through inoculation. Louis Pasteur, in 1864, proved the existence of microorganisms and that they reproduced. Thereafter in 1865, Gregor Mendel demonstrated the inheritance of traits from one generation to another in the pea plant, establishing the beginning of the field of genetics. Then in 1869, Johann Meische isolated DNA from the nuclei of white blood cells. It is noteworthy that the work of these scientists was beyond any regulatory mechanisms of the time.
The strong mercantile, commerce and regulatory interests in butter and cheese lead to the development of the New York Stock Exchange. The Exchange began when the Butter and Cheese Exchange of New York was created. On June 1, 1875, this Exchange became the American Exchange of New York, and then on April 26, 1880, it became the Butter, Cheese and Egg Exchange of the City of New York. Finally, on June 5, 1882, the Exchange changed its name to the New York Mercantile Exchange [4].”
The next major breakthrough in the field of biology came in 1859 with the publication of On the Origin of Species by Charles Darwin. In it, Darwin proposed the theory of evolution by natural selection, which is the idea that species can change over time through the process of natural selection. Darwin's work was based on his observations of the natural world, and he was able to provide convincing evidence that his theory was correct. Darwin's work helped to explain how species could change over time, and it had a profound impact on the field of biology. In the years that followed, Darwin's work was expanded upon by other biologists, and the theory of evolution became one of the most important ideas in the field of biology.
THE RISE OF MODERN MEDICINE
The 19th century was the culmination of the scientific discoveries of the Enlightenment period, and the English term “biology” was coined [4]. The rise of modern medicine can also be traced back to this period when the progress of science and the advances in laboratory techniques contributed to the creation of a medical market. From a regulatory perspective, the production of medicines did not follow any legal or commercial standard and the sale of so-called “patent medicines” became a major industry.
Patent medicines originally referred to medicines or nostrum (“our remedy” in Latin) that traditionally contained secret ingredients. These concoctions were generally advertised to consumers as over-the-counter products without regard to their actual effectiveness [5]. They often contained high doses of alcohol and narcotics such as cocaine, heroin or morphine and, some of them, were specifically advertised for infants.
Originating in England during the late 17th century as proprietary medicines manufactured under “patents of royal favor”, these medicines became very successful within the American colonies and some of them survived well into the 20th century, such as Hooper's Female Pills, Godfrey's Cordiar, Bateman's Pectoral Drops, Turlington's Balsam of Life, and Anderson's Scots Pills [6]. Despite the name, however, patent medicines were not legally registered in the United States, they were mostly kept as secret imitations of the old British brands.
“Widespread counterfeiting by American druggists changed the English patent medicine names, as a Massachusetts court recognized, from designations for truly proprietary articles to generic designations for general classes of medicines. The badge of proprietorship had shifted to the brash new American brands. The American promoter, marketing his pill or potion, certainly profited from the promotional experience of his British predecessors. They had exploited distinctive names-Turlington’s Balsam of Life, Daffy’s Elixir Salutis, Bateman’s Pectoral Drops, for example. They had put up their medicines in bottles of novel shapes. They had shipped their remedies to all American ports from Boston to Savannah. The British medicine makers had wrapped their bottles in sheets printed with extravagant claims. They had employed great ingenuity in devising adverti-sements for English newspapers, but seldom advertised at all in the colonial press. American apothecaries, when a fresh assortment of patent medicines arrived from London, listed the names without elaboration in short newspaper notices [7].”
The outbreak of the Civil War also helped trigger the use of patent medicines and, in particular, those containing narcotic substances. Narcotics were effective painkillers and were regularly used for treating a variety of medical conditions, ranging from coughing and diarrhea to malaria and emotional disturbances. Morphine was used to treat battlefield injuries. It was also used as a recreational drug by both Union and Confederate soldiers. The use of opium-based drugs such as laudanum and paregoric became widespread during the war. These drugs were often mixed with alcohol or other substances to make them more potent.
“Despite the known risks of opiate addiction, facing the health crisis of the Civil War—which Margaret Humphreys has aptly described as “the greatest health disaster” in American history—military surgeons had few alternatives to opiates, the era’s most effective painkillers and antidiarrheal medicines. Surgeons realized that armies simply could not function without opiates’ therapeutic benefits. A Confederate medical handbook explained this concept in martial terms: “Opium is the one indispens- able drug on the battlefield—important to the surgeon, as gunpowder to the ordnance.” Indeed, the handbook instructed surgeons to administer opiates to mitigate pain, arrest vomiting, diarrhea, and internal bleeding, to counteract inflammation from gunshot wounds and muscle spasms of amputees’ stumps, and even to sedate troublesome patients. The Union military requisitioned huge quantities of opiates—about 5.3 million opium pills and 2.8 million ounces of opiate preparations—and throughout the Civil War surgeons liberally administered the medicines to soldiers afflicted by pain and a legion of sicknesses, particularly diarrheal ailments. Although medical supplies became scarce late in the war, Confederate surgeons likewise prescribed opiates copiously when possible. In August and September of 1864, during the siege of Petersburg, surgeons at the Second North Carolina Military Hospital included opiates in 40 percent of their prescriptions [8].”
Bonesetters, chiropodists, cancer doctors, oculists and aurists operated without professional sanction despite their lack of formal education. With no criminal regulations, any drug could be sold and marketed as a cure for any disease regardless of its biomedical efficacy. Newspapers were filled with lots of adverts proclaiming miracle cures to treat everything from war wounds to cancer.
Drug makers soon realized this was an ideal way to sell their “cure-alls” products.
Drug companies also targeted the thousands of soldiers who returned to civilian life when their fighting was over and suffered the long-term consequences of battlefield wounds. After the war, many veterans continued to use these drugs for pain relief or to cope with post-traumatic stress disorder (PTSD). The widespread use of narcotics led to a rise in addiction rates.
In addition to acquainting soldiers with various brands of pills and potions, the war helped the remedy manufacturers in another way. Thousands of soldiers returned to civilian life with ruined digestions, malaria, wounds, emotional disturbances, and other ailments that were to cause them trouble for the rest of their lives. Nostrum-makers were not unaware of this. Thirty years after Appomattox, the Dr. Williams Medicine Company, maker of Pink Pills for Pale People, aimed a pamphlet at the old boys in blue. “Out of the 1,000,000 men mustered out in '65,” the message began, “only about 500,000 are now alive.” Why this halving of the noble ranks? “Exposure, miasma, bad food, hardships of every description—these and not the bullets are responsible for the extremely rapid death-rate among the veterans.” “it is not alone those who were wounded who deserve our sympathy,” asserted the Pink Pill pamphleteer, “it is the great majority who were not, but who contracted the seeds of disease in Southern swamps and prisons, and who have as a consequence lost their health before their time [9].”
The growth of the production of patent medicines coincided with the rise of the “prohibition movement” which had as its objective the limitation of the consumption of alcoholic beverages in the United States. The consumption of
alcohol through the use of patent medicines, in fact, often represented a valid social reason to overcome the restrictions.
THE GREAT AMERICAN FRAUD
In 1905, however, the work of muckraking journalists such as Samuel Hopkins Adams and Upton Sinclair exposed many of the false and often fraudulent claims made by patent medicine producers. In the book The Great American Fraud, the American journalist Samuel Hopkins Adams made the general public aware of the risks and dangers of patent medicines. The book begins,
“Gullible America will spend some seventy-five million dollars this year in the purchase of patent medicines. In consideration of this sum, it will swallow huge quantities of alcohol, an appalling amount of opiates and narcotics, a wide assortment of varied drugs ranging from powerful and dangerous heart depressants to insidious liver stimulants; and, in excess of all other ingredients, undiluted fraud. For fraud, exploited by the most skillful of advertising bunco men, is the basis of the trade. Should the newspapers, magazines and medical journals refuse their pages to this class of advertisements, the patent medicine business in five years would be as scandalously historic as the South Sea Bubble, and the nation would be the richer not only in lives and money, but in drunkards and drug-fiends saved [1].”
Adams' investigation revealed that many patent medicines contained alcohol, opium, or other drugs, and that their claims of being able to cure everything from cancer to baldness were false. He also exposed the unethical practices of some doctors who were paid to endorse these products.
The Jungle is a groundbreaking work of investigative journalism that exposed the dark side of the food industry. In the book, the novelist Upton Sinclair portrays the harsh conditions of immigrants in the meatpacking plants of Chicago and other industrialized cities. It reveals the use of poisonous preservatives and dyes in the food processing industry.
The book contains shocking disclosures of the insanitary conditions of the food processing industry:
“They had chains which they fastened about the leg of the nearest hog, and the other end of the chain they hooked into one of the rings upon the wheel. So, as the wheel turned, a hog was suddenly jerked off his feet and borne aloft. At the same instant, the ear was assailed by a terrifying shriek; the visitors started alarmingly, and the women turned pale and shrank back. The shriek was followed by another, louder and yet more agonizing--for once started upon that journey, the hog never came back; at the top of the wheel, he was shunted off upon a trolley and went sailing down the room. And meantime, another was swung up, and then another, and another, until there was a double line of them, each dangling by a foot and kicking in a frenzy--and squealing. The uproar was appalling, perilous to the ear-drums; one feared there was too much sound for the room to hold--that the walls must give way or the ceiling crack. There were high squeals and low squeals, grunts, and wails of agony; there would come a momentary lull, and then a fresh outburst, louder than ever, surging up to a deafening climax. It was too much for some of the visitors--the men would look at each other, laughing nervously, and the women would stand with hands clenched, blood rushing to their faces, and tears starting in their eyes. Meantime, heedless of all these things, the men upon the floor were going about their work. Neither squeals of hogs nor tears of visitors made any difference to them; one by one, they hooked up the hogs, and one by one, with a swift stroke, they slit their throats. There was a long line of hogs, with squeals and life-blood ebbing away together; until at last, each started again, and vanished with a splash into a huge vat of boiling water. It was all so very businesslike that one watched it fascinated. It was pork-making by machinery, pork-making by applied mathematics. And yet somehow, the most matter-of-fact person could not help thinking of the hogs; they were so innocent, they came so trustingly; and they were so human in their protests--and so perfectly within their rights! They had done nothing to deserve it; and it was adding insult to injury, as the thing was done here, swinging them up in this cold-blooded, impersonal way, without a pretense at apology, without the homage of a tear. Now and then, a visitor wept, to be sure; but this slaughtering-machine ran on, visitors or no visitors. It was like some horrible crime committed in a dungeon, all unseen and unheeded, buried out of sight and of memory [10].”
In the wake of exposés by these journalists, Congress enacted the Meat Inspection Act of 1906, which ensured sanitary slaughtering of livestock and government inspection of meat products. The act required all meatpacking plants to be inspected and regulated by the federal government. The act also created the position of Federal Meat Inspector, who was responsible for ensuring that all meatpacking plants met the standards set by the act.
The Meat Inspection Act expressly stated:
For the purpose of preventing the use in interstate or foreign commerce of meat and meat food products which are unsound, unhealthy unwholesome, or otherwise unfit for use as human food, the Secretary of Agriculture may order inspectors to examine and inspect all cattle, sheep, swine, and goats before they shall be allowed to enter any slaughtering, packing, meat-canning, rendering, or similar establishment; and all cattle swine, sheep, and goats found on such inspection to show symptoms of disease shall be set apart and slaughtered separately from cattle, etc., shall be subject to examination, and all carcasses or labeled, marked, stamped, or tagged as “Inspected and condemned’ and shall be destroyed for food purposes by the establishment [meatpacker]in the presence of an inspector.
THE POISON SQUAD AND THE LEGISLATIVE HISTORY OF THE PURE FOOD AND DRUGS ACT
Along with the Meat Inspection Act, President Theodore Roosevelt pushed the Congress to pass the Pure Food and Drug Act of 1906, known simply as the Wiley Act. Dr. Harvey Washington Wiley was the head of the Bureau of Chemistry in the U.S. Department of Agriculture and played a central role in shaping the pure food legislation. Wiley was born in a Quaker family in Indiana. He studied chemistry at Purdue University and received his Ph.D. from Johns Hopkins University. After working as a professor of chemistry, he joined the U.S. Department of Agriculture in 1883 as the head of the Bureau of Chemistry. In this position, he conducted research on food adulteration and lobbied for stricter regulation of the food industry. In one of his works, he discusses the questionable contents of food:
“I WONDER WHAT’S IN IT”
We sit at a table delightfully spread
And teeming with good things to eat.
And daintily finger the cream-tinted bread,
Just needing to make it complete
A film of the butter so yellow and sweet,
Well suited to make every minute
A dream of delight. And yet while we eat
We cannot help asking, “What’s in it?”
Oh, maybe this bread contains alum or chalk
Or sawdust chopped up very fine
Or gypsum in powder about which they talk,
Terra alba just out of the mine.
And our faith in the butter is apt to be weak,
For we haven’t a good place to pin it
Annato’s so yellow and beef fat so sleek
Oh, I wish I could know what is in it.
The pepper perhaps contains cocoanut shells,
And the mustard is cottonseed meal;
And the coffee, in sooth, of baked chicory smells,
And the terrapin tastes like roast veal.
The wine which you drink never heard of a grape,
But of tannin and coal tar is made;
And you could not be certain, except for their shape,
That the eggs by a chicken were laid.
And the salad which bears such an innocent look
And whispers of fields that are green
Is covered with germs, each armed with a hook
To grapple with liver and spleen.
The banquet how fine, don’t begin it
Till you think of the past and the future and sigh,
“How I wonder, I wonder, what’s in it [11].”
Before the enactment of the 1906 Pure Food and Drug Act, Dr. Wiley personally inspected the long-term effects of food additives together with a group of medical students from Georgetown Medical College who voluntarily consumed poison so that Dr. Wiley could assess the level of chemicals in their bodies. The students were given various food additives to eat, and their health was monitored over time. This helped Dr. Wiley to understand the long-term effects of these chemicals on the human body. This group of young students came to be known as “The Poison Squad” because of their willingness to put their own health at risk for the sake of science.
As Deborah Blum notes:
“By the end of the nineteenth century, the sweeping industrial revolution—and the rise of industrial chemistry—had also brought a host of new chemical additives and synthetic compounds into the food supply. Still unchecked by government regulation, basic safety testing, or even labeling requirements, food and drink manufacturers embraced the new materials with enthusiasm, mixing them into goods destined for the grocery store at sometimes lethal levels.
The most popular preservative for milk—a product prone to rot in an era that lacked effective refrigeration—was formaldehyde, its use adapted from the newest embalming practices of undertakers. Processors employed formaldehyde solutions—sold under innocuous names such as Preservaline—to restore decaying meats as well. Other popular preservatives included salicylic acid, a pharmaceutical compound, and borax, a mineral-based material best known as a cleaning product.
Food manufacturers also adopted new synthetic dyes, derived from coal by-products, to improve the color of their less appealing products. They found inexpensive synthetic compounds that they could secretly substitute into food and drink—saccharin to replace sugar; acetic acid instead of lemon juice; lab-created alcohols, dyed and flavored, to mimic aged whiskeys and fine wines. As progressive Wisconsin senator Robert M. La Follette described such practices in 1886: “Ingenuity, striking hands with cunning trickery, compounds a substance to counterfeit an article of food. It is made to look like something it is not; to taste and smell like something it is not; to sell something it is not, and so to deceive the purchaser.
No wonder, then, that when alarmed citizens began pushing for federal help in checking such fraud and fakery, they did so under the banner of purity. They saw themselves as “pure food” crusaders, fighting to clean up not only a contaminated supply chain but also a system that was dirty to its roots and protected by politicians friendly to industry […] The leaders of the pure-food movement united behind the idea that regulatory oversight was the only realistic answer. They’d seen many times that the country’s food processors and manufacturers felt little or no responsibility to protect the food supply, especially if it meant reducing profits. Formaldehyde, for instance, had been directly linked to deaths—notably of children drinking what came to be called embalmed milk—without any move by producers to discontinue the preservative’s use. The preservative’s usefulness in salvaging bad milk—otherwise unsalable—was too valuable to lose.
American corporations had successfully and repeatedly blocked efforts to pass even modest food safety legislation. This especially galled consumer safety advocates because governments in Europe were enacting protective measures; some foods and drinks sold freely in the United States were now banned abroad. Unlike their American counterparts, European beer and wine makers were blocked from using risky preservatives in their beverages (although they could put them in products destined for U.S. sales) [11].”
Dr. Wiley's efforts to promote food safety culminated in the passage of the Pure Food and Drug Act in 1906 [12]. The Act was designed to “prevent the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes”. It authorized the Bureau of Chemistry to examine drugs in order to assess their purity and quality. Products found in violation of the Act were subject to seizure and/or prosecution.
One of the most important aspects of the Pure Food and Drug Act was its focus on labeling. For the first time, companies were required to list all of the ingredients in their products on the label. This allowed consumers to make informed choices about what they were buying and also helped to weed out products that contained harmful ingredients. The act also prohibited false advertising, which had been rampant prior to its passage.
Section 7 of the Act regulated adulterated products:
“An article shall be deemed to be adulterated:
In the case of drugs:
First. If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or Natural Formulary, it differs from the standard or strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of the investigation: Provided, That no drug defined in the United States Pharmacopoeia or National Formulary shall be deemed to be adulterated under this provision if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other containers thereof although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary.
Second. If its strength or purity falls below the professed standard or quality under which it is sold.
In the case of confectionery:
If it contains terra alba, barytes, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt or spirituous liquor or compound narcotic drug.
In the case of food:
First. If any substance has been mixed and packaged with it so as to reduce or lower or injuriously affect its quality or strength.
Second. If any substance has been substituted wholly or in part for the article.
Third. If any valuable constituent of the article has been wholly or in part abstracted.
Fourth. If it be mixed, colored, powdered, coated, or combined in a manner whereby damage or inferiority is concealed.
