TITLE 16

Health and Safety

Food and Drugs

CHAPTER 33. PURE FOOD AND DRUGS


As used in this chapter:

(1) "Drug'' includes all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use and any substance or mixture of substances intended to be used for the cure, mitigation or prevention of disease of either humans or other animals. Notwithstanding any other provision of this subdivision, the word "drug'' shall not include laetrile (amygdalin).

(2) "Food'' includes all articles used for food, drink, ice, confectionery or condiment by humans or other animal, whether simple, mixed or compound.

32 Del. Laws, c. 190, § 2; Code 1935, § 3994; 16 Del. C. 1953, § 3301; 61 Del. Laws, c. 90, § 1; 66 Del. Laws, c. 314, § 1; 70 Del. Laws, c. 186, § 1.;

No person shall manufacture, sell or trade in, within this State, any article of food or drugs which is adulterated, misbranded, poisonous or deleterious within the meaning of this chapter.

32 Del. Laws, c. 190, § 1; Code 1935, § 3993; 16 Del. C. 1953, § 3302.;

A drug is deemed to be adulterated:

(1) If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differs from the standard of strength, quality or purity as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation. No drug defined in the United States Pharmacopoeia or National Formulary shall be deemed to be adulterated under this subdivision if the standard of strength, quality or purity is plainly stated upon the bottle, box or other container thereof although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary.

(2) If its strength or purity falls above or below the professed quality under which it is sold.

(3) If it violates the definition of adulteration as stated in the Federal Food, Drug and Cosmetic Act.

32 Del. Laws, c. 190, § 3; Code 1935, § 3995; 16 Del. C. 1953, § 3303; 63 Del. Laws, c. 83, §§ 1, 2.;

Food is deemed to be adulterated:

(1) If any substance has been mixed and packed with it so as to reduce or lower or injuriously affect its quality or strength;

(2) If any substance has been substituted wholly or in part for the article of food;

(3) If any valuable constituent of the article of food has been wholly or in part abstracted;

(4) If it is mixed, colored, powdered, coated or stained in a manner whereby damage or inferiority is concealed;

(5) If it contains any added poisonous or other added deleterious ingredient which may render the article of food injurious to health. When in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically or by maceration in water, or otherwise, and directions for the removal of the preservative are printed on the covering or the package, this chapter shall be construed as applying only when the products are ready for consumption;

(6) If it consists in whole or in part of a filthy, decomposed or putrid animal or vegetable substance or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a deceased animal or one that has died otherwise than by slaughter.

32 Del. Laws, c. 190, § 3; Code 1935, § 3995; 16 Del. C. 1953, § 3304.;

Confectionery is deemed to be adulterated 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 or narcotic drug.

32 Del. Laws, c. 190, § 3; Code 1935, § 3995; 16 Del. C. 1953, § 3305.;

Adulterated candy shall be forfeited and destroyed under the direction of the Attorney General.

21 Del. Laws, c. 267; Code 1915, § 3513; Code 1935, § 3996; 16 Del. C. 1953, § 3306.;

The term "misbranded,'' as used in this chapter, applies to all drugs or articles of food, or articles which enter into the composition of food, the package or label of which bears any statement, design or device regarding such article or the ingredients or substances contained therein which is false or misleading in any particular, and to any food or drug product which is falsely branded as to the state, territory or country in which it is manufactured or produced.

32 Del. Laws, c. 190, § 4; Code 1935, § 3997; 16 Del. C. 1953, § 3307.;

For the purposes of this chapter, a drug is deemed to be misbranded:

(1) If it is an imitation of or offered for sale under the name of another drug;

(2) If the contents of the package as originally put up were removed, in whole or in part, and other contents were placed in such package or if the package fails to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate or acetanilide, or any derivative or preparation of any such substances contained therein;

(3) If its package or label bears any statement, design or device regarding such article, or the ingredients or substances contained therein which is false or misleading in any particular way;

(4) If it is included in the definition of misbranding in the Federal Food, Drug and Cosmetic Act.

32 Del. Laws, c. 190, § 4; Code 1935, § 3997; 16 Del. C. 1953, § 3308; 63 Del. Laws, c. 83, §§ 3, 4.;

For the purposes of this chapter, food is deemed to be misbranded:

(1) If it is an imitation of or offered for sale under the distinctive name of another food;

(2) If it is labeled or branded so as to deceive or mislead the purchaser or purports to be a foreign product when not so or if the contents of the package as originally put up were removed in whole or in part and other contents were placed in such package or if it fails to bear a statement on the label of the quantity or proportion of any morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate or acetanilide, or any derivative or preparation of any of such substances contained therein;

(3) If in package form, the quantity of the contents is not plainly and conspicuously marked on the outside of the package in terms of weight, measure or numerical count;

(4) If the package containing it or its label bears any statement, design or device regarding the ingredients or the substances contained therein, which statement, design or device is false or misleading in any particular;

(5) If it is obtained by the dealer in frozen bulk form and is subsequently thawed and offered for sale in a package or bearing a label indicating such food to be fresh.

32 Del. Laws, c. 190, § 4; Code 1935, § 3997; 16 Del. C. 1953, § 3309; 56 Del. Laws, c. 37.;

An article of food which does not contain any added poisonous or deleterious ingredients is not deemed to be adulterated or misbranded in the following cases:

(1) In the case of mixtures or compounds known as articles of food under their own distinctive names and not an imitation of or offered for sale under the distinctive name of another article, if the name is accompanied on the same label or brand with a statement of the place where the article was manufactured or produced;

(2) In the case of articles labeled, branded or tagged so as to plainly indicate that they are compounds, imitations or blends and the word "compound,'' "imitation'' or "blend,'' as the case may be, is plainly stated on the package in which it is offered for sale. The term "blend'' as used in this subdivision shall be construed to mean a mixture of like substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and flavoring only. Nothing in this chapter shall be construed as requiring or compelling proprietors or manufacturers of proprietary foods which contain no unwholesome added ingredient to disclose their trade formulas, except insofar as the provisions of this chapter require in order to secure freedom from adulteration or misbranding.

32 Del. Laws, c. 190, § 4; Code 1935, § 3997; 16 Del. C. 1953, § 3310.;

No dealer shall be prosecuted under this chapter when the dealer can establish a guaranty signed by the wholesaler, jobber, manufacturer or other party residing in the United States from whom the dealer purchases such articles to the effect that the same is not adulterated or misbranded within the meaning of this chapter. The guaranty, to afford protection, shall contain the name and address of the party making the sale of such articles to such dealer and, in such case, the party shall be amenable to the prosecutions, fines and other penalties which would attach, in due course, to the dealer under this chapter.

32 Del. Laws, c. 190, § 5; Code 1935, § 3998; 16 Del. C. 1953, § 3311; 70 Del. Laws, c. 186, § 1.;

(a) Whoever violates §§ 3302-3311 of this title shall, for each offense, be fined not more than $500 or imprisoned not more than 1 year, or both. For each subsequent offense the violator shall be fined not more than $1,000 or imprisoned for 1 year, or both.

(b) When construing and enforcing this chapter, the act, omission or failure of any officer, agent or other person acting for or employed by any corporation, company, society or association, within the scope of that person's own employment or office, shall in every case be also deemed to be the act, omission or failure of such corporation, company, society or association as well as that of the person.

24 Del. Laws, c. 160, § 10; Code 1915, § 3523; 32 Del. Laws, c. 190, § 6; Code 1935, § 3999; 16 Del. C. 1953, § 3312; 70 Del. Laws, c. 186, § 1.;

This chapter shall not apply to articles of food or to mixtures or compounds of foods offered for sale in this State when prepared, labeled, branded or inspected in compliance with the federal laws and department regulations established thereunder.

24 Del. Laws, c. 160, § 4; Code 1915, § 3517; Code 1935, § 4000; 16 Del. C. 1953, § 3313.;

An offense is not deemed to be committed under this chapter, in the following cases:

(1) Where the order calls for an article of food or drug inferior to the standard required under this chapter and the difference is made known at the time;

(2) Where the article of food or drug is mixed with any matter or ingredient not injurious to health and not intended fraudulently to increase its bulk, weight or measure or conceal its inferior quality, if at the time such article is delivered to the purchaser it is made known to the purchaser that the article of food or drug is so mixed.

24 Del. Laws, c. 160, § 5; Code 1915, § 3518; Code 1935, § 4001; 16 Del. C. 1953, § 3314; 70 Del. Laws, c. 186, § 1.;

(a) The Department of Health and Social Services shall enforce all the provisions of this chapter and shall promulgate rules and regulations to carry out the same so far as they relate to foods. The State Board of Pharmacy shall enforce all the provisions of this chapter and shall promulgate rules and regulations for carrying out the same so far as they relate to drugs, including proper methods for handling volatile and variable drugs.

(b) Such rules shall provide for the examination and analysis of specimens and shall give the party from whom a specimen is obtained opportunity to verify any findings and to be heard before prosecution. The rules and regulations officially prescribed for the enforcement of the Federal Food, Drug and Cosmetic Act, and acts amendatory thereof [21 U.S.C. § 301 et seq.], so far as applicable, shall be adopted by the officials referred to in subsection (a) of this section for the enforcement of this chapter. No rule or regulation shall be promulgated under subsection (a) of this section which is in conflict with Chapter 49 of this title.

24 Del. Laws, c. 160, § 7; Code 1915, § 3520; 33 Del. Laws, c. 57, § 4; 34 Del. Laws, c. 69, § 1; Code 1935, § 4002; 16 Del. C. 1953, § 3315; 61 Del. Laws, c. 90, § 3; 70 Del. Laws, c. 149, §§ 149, 150.;

The expenses incurred by all officials in performing the duties imposed by §§ 3302-3317 of this title, including reasonable compensation for services rendered, shall be paid by requisition upon the State Treasurer, when approved by the Governor, out of the funds in hand not otherwise appropriated.

24 Del. Laws, c. 160, § 9; Code 1915, § 3522; Code 1935, § 4003; 16 Del. C. 1953, § 3316.;

No person shall sell or offer to sell by that person's own self, or by that person's servants or agents, or as the servant or agent of any other person, any meat or flesh of any animal used for food after the same has been butchered which contains any drug or preparation of whatever kind or nature, deleterious or detrimental to the health of persons who may eat the same, or which has been treated with, either externally or internally, or to which has been applied in any manner, any drug or preparation of whatsoever kind or nature, deleterious or detrimental to the health of persons who may eat the same, whether for the purpose of preserving meat or flesh used for food or for any other purpose.

23 Del. Laws, c. 212, § 1; Code 1915, § 3524; Code 1935, § 4004; 16 Del. C. 1953, § 3317; 70 Del. Laws, c. 186, § 1.;

(a) If any person makes complaint in writing, verified by oath or affirmation before any justice of the peace or other court having criminal jurisdiction, alleging that the complainant has probable cause to suspect and does suspect and believe that any person, by that person's own self or by that person's servants or agents, has sold or offered or exposed for sale or has in that person's own possession with intent to sell, any meat or flesh of any animal to be used for food which has been treated with or which contains any drug or preparation as mentioned in § 3317 of this title, and in the complaint describes such meat as particularly as may be and designates the house or place where complainant suspects and believes such meat or flesh is kept or sold and the name of the persons suspected, the justice of the peace or such court may, within the limits of the justice of the peace's or its jurisdiction, issue a warrant to search such house or place.

(b) The warrant shall be directed to any officer or to any other person by name for service and shall recite the essential parts alleged in the complaint, and the officer or other person to whom it shall be directed for service shall proceed thereunder as provided in subsection (c) of this section.

(c) The officer or person to whom the warrant is directed may enter the house or place designated and, if the officer or person finds therein what the officer or person believes to be any meat or flesh such as is described in § 3317 of this title, the officer or person shall take a sample or samples for the purpose of having the same analyzed or tested as provided in this section. To obtain such sample or samples the officer or other person to whom the warrant is directed may cut pieces from any such meat or flesh by the officer or person believed to be treated with or containing any drug or preparation within the meaning of § 3317 of this title. The officer or other person to whom the warrant is directed, when taking a sample or samples of meat or flesh, shall then and there divide the samples into 2 parts as nearly equal as may be, wrap the parts in separate packages, seal the same and offer 1 of the parts to the person in whose custody the meat was when taken with a written notice of the time, place and date, when and where the sample was taken, and that it was taken for the purpose of analyzing or testing it. The other part of the sample, together with a written copy of the written notice, shall be delivered by the officer or other person to whom the warrant is directed to the State Chemist, who shall cause the same to be analyzed or otherwise satisfactorily tested, the result of which analysis or test the State Chemist shall record and preserve as evidence.

(d) The officer or other person to whom the warrant was directed shall, within 1 week after delivery to the State Chemist, return the warrant with officer's or other person's proceedings thereunder and the costs and actual expenses endorsed thereon to the justice of the peace or court, the costs to correspond in amount as nearly as may be with the costs to which an officer serving a search warrant would thereby be entitled.

(e) After the sample has been delivered to the State Chemist, the State Chemist shall, with all convenient speed, analyze or test the same and upon the completion thereof shall forward to the Attorney General a certificate of the result thereof, duly verified by oath or affirmation, and the certificate so verified shall be admitted as evidence in any prosecution under §§ 3317 and 3319 of this title.

(f) The provisions of this section relating to searches and seizures shall be subject to Chapter 23 of Title 11. If there is any conflict or inconsistency between this section and such chapter, the latter shall prevail.

23 Del. Laws, c. 212, § 2; Code 1915, § 3525; Code 1935, § 4005; 16 Del. C. 1953, § 3318; 70 Del. Laws, c. 186, § 1.;

(a) Whoever violates § 3317 of this title shall be fined not less than $50 nor more than $100, or imprisoned not more than 3 months, and pay the costs of prosecution, among which shall be taxed the costs of the justice of the peace, the costs and actual expenses endorsed upon the warrant and the charge of the State Chemist, whose charge shall not in any case exceed the sum of $10.

(b) In case of failure to convict the charge of the State Chemist, the costs of the justice of the peace and the costs and actual expenses endorsed upon the warrant shall be paid by the county in which the prosecution is conducted. The amount of money to be paid by any county shall not exceed in any 1 year the sum of $200.

23 Del. Laws, c. 212, § 3; Code 1915, § 3526; Code 1935, § 4006; 16 Del. C. 1953, § 3319.;

(a) Subject to subsection (b) and (c) of this section, no person, by that person's own self or that person's agents or servants, shall render or manufacture, sell, offer for sale, expose for sale or have in that person's possession with intent to sell, any article, product or compound made wholly or partly out of any fat, oil or oleaginous substance, or compound thereof, not produced from unadulterated milk or cream from the same, which shall be in imitation of yellow butter produced from pure unadulterated milk, or cream from the same.

(b) Nothing contained in subsection (a) of this section or in § 3321 or 3322 of this title shall be construed to prohibit the manufacture or sale of oleomargarine, whether yellow or white, in a separate and distinct form in such manner as will advise the consumer of its real character. No oleomargarine shall be sold in open tubs or containers. Every retail dealer in oleomargarine shall exhibit, in conjunction with any display of packaged oleomargarine being offered for sale, a placard with the word "oleomargarine'' in plain uncondensed gothic letters not less than 1 inch high. No package of oleomargarine shall contain the word "butter'' or any imitation or simulation thereof or any picture or reproduction of a cow or any name or simulation of the name of any dairy breed of cattle or any name or term normally used in the dairy industry. No owner or proprietor of any public eating place shall serve yellow oleomargarine unless a notice that oleomargarine is served is displayed prominently on the menu or on a placard in clear view of all customers.

(c) As used in this section the term "oleomargarine'' shall be deemed applicable to the food product known as "margarine'' and any requirement contained in this section for labeling or display of the word "oleomargarine'' shall be deemed sufficiently complied with by the use of the word "margarine.''

20 Del. Laws, c. 209, § 1; 22 Del. Laws, c. 161, § 1; Code 1915, § 3527; 33 Del. Laws, c. 216; Code 1935, § 4007; 48 Del. Laws, c. 14, § 1; 16 Del. C. 1953, § 3320; 70 Del. Laws, c. 186, § 1.;

(a) If any person makes complaint in writing, verified by oath or affirmation before any justice of the peace or other court having criminal jurisdiction, alleging that the complainant has probable cause to suspect and does suspect and believe that any other person by that person's own self, or that person's agents or servants, has rendered or manufactured, sold, offered or exposed for sale or has in that person's possession with intent to sell, contrary to § 3320 of this title, any article, product or compound made in imitation of yellow butter and in the complaint describes the article, product or compound as particularly as may be and designates the house or place where complainant suspects and believes the article, product or compound is and the name of the person suspected, the justice of the peace or such court may, within the limits of the justice of the peace or its jurisdiction, issue a warrant to search such house or place.

(b) The warrant shall be directed to any officer or to any other person by name for service and shall recite the essential facts alleged in the complaint, and the officer or other person to whom it is directed for service shall proceed thereunder as provided in subsection (c) of this section.

(c) The officer or other person to whom the warrant is directed may enter the house or place designated and if that officer or person finds therein what that officer or person believes to be any article, product or compound made in imitation of yellow butter, contrary to § 3320 of this title, that officer or person shall take a sample or samples thereof for the purpose of having the same analyzed or tested as provided in this section. To obtain such sample or samples, the officer or other person to whom the warrant is directed may open any can, vessel or package by that officer or person believed to contain such imitation article, product or compound and take therefrom the sample or samples. The officer or other person to whom the warrant is directed, when taking a sample or samples of the alleged imitation article, product or compound, shall then and there divide the sample into 2 parts as nearly equal as may be, wrap the parts in separate packages, seal the same and offer 1 of the parts to the person in whose custody the article was when taken with a written notice of the time, place and date, when and where the sample was taken and that it was taken for the purpose of analyzing or testing it. The other part of the sample, together with a copy of the written notice, shall be delivered by the officer or other person to whom the warrant is directed to the State Chemist, who shall cause the same to be analyzed or otherwise satisfactorily tested, the result of which analysis or test the State Chemist shall record and preserve as evidence.

(d) The officer or other person to whom the warrant was directed shall, within 1 week after delivery to the State Chemist, return the warrant with that officer's or person's proceedings thereunder and that officer's or person's costs and actual expenses endorsed thereon to the justice of the peace or court, the costs to correspond in amount as nearly as may be with the costs to which an officer serving a search warrant would thereby be entitled.

(e) After the sample has been delivered to the State Chemist, the State Chemist shall, with all convenient speed analyze or test the same and upon the completion thereof shall forward to the Attorney General a certificate of the result thereof duly verified by oath or affirmation, and the certificate so verified shall be admitted as evidence in any prosecution under § 3320 of this title.

(f) This section relating to searches and seizures shall be subject to Chapter 23 of Title 11. If there is any conflict or inconsistency between this section and such chapter, the latter shall prevail.

20 Del. Laws, c. 209, § 2; Code 1915, § 3528; Code 1935, § 4008; 16 Del. C. 1953, § 3321; 70 Del. Laws, c. 186, § 1.;

(a) Whoever violates § 3320 of this title shall be fined not less than $50 nor more than $250, or imprisoned not more than 1 year, and pay the costs of prosecution, among which shall be taxed the costs of the justice of the peace, the costs and actual expenses endorsed upon the warrant and the charge of the State Chemist, whose charge shall not in any 1 case exceed the sum of $20.

(b) In case of failure to convict, the charge of the State Chemist, the costs of the justice of the peace and the costs and actual expenses endorsed upon the warrant shall be paid by the county in which the prosecution is conducted. The amount of money to be paid by any county shall not exceed in any year the sum of $200.

20 Del. Laws, c. 209, § 3; Code 1915, § 3529; Code 1935, § 4009; 16 Del. C. 1953, § 3322.;

(a)(1) When a duly authorized agent of the Department of Health and Social Services, when food is involved, or of the Board of Pharmacy, when drugs are involved, finds or has probable cause to believe that any food or drug as defined by this chapter is adulterated or so misbranded as to be dangerous or fraudulent within the meaning of this chapter, or is in violation of § 3303, 3304, 3308 or 3309 of this title, the agent shall affix to such article a tag or other appropriate marking. This tag or marking shall give notice that such article is, or is suspected of being, adulterated or misbranded and has been detained or embargoed. The tag or other appropriate marking shall warn all persons not to remove or dispose of such article by sale or otherwise until permission for removal or disposal is given by an authorized agent or the Court. It shall be unlawful for any person to remove or dispose of such detained or embargoed article by sale or otherwise without such permission.

(2) When an authorized agent has found that an article which is embargoed or detained is not adulterated or misbranded, the agent shall remove the tag or other markings and it may be disposed of by sale or otherwise by the owner.

(b) When an article is adulterated or misbranded or is in violation of § 3303, 3304, 3308 or 3309 of this title, it shall be liable to be proceeded against by petition to the justice of the peace or the judge of the Court of Common Pleas in whose jurisdiction the article is located, detained or embargoed for a decree of condemnation of such article.

(c) If the Court finds that a sampled, detained or embargoed article is adulterated or misbranded, such article shall, after entry of the decree, be destroyed at the expense of the owner thereof, under the supervision of an authorized agent. All court costs and fees, and storage and other expenses, shall be charged against the owner of such article or the owner's agent. If adulteration or misbranding can be corrected by proper labelling or processing of the article, the Court, after entry of the decree may, by order, direct that such article be delivered to the owner thereof for such labelling or processing under the supervision of an agent of the State Board of Pharmacy or the Department of Health and Social Services. Expense of such supervision and any other costs, fees or expenses involved shall be paid by the owner. A sufficient bond shall be executed on the condition that the articles shall be properly labelled or processed. The article shall be returned to the owner and the bond shall be discharged on the representation to the Court by the Department of Health and Social Services or the Board of Pharmacy or their authorized agents that the article is no longer in violation of this chapter, and that the expenses of such supervision have been paid. The tag or markings described in paragraph (1) of subsection (a) of this section may then be removed.

(d) The Department of Health and Social Services or its authorized agents shall condemn or destroy, or otherwise render unsaleable as human food, any meat, seafood, poultry, vegetable, fruit or other perishable articles which are unsound, or contain any filthy, decomposed or putrid substance, or that may be poisonous or deleterious to the health, or are otherwise unsafe. This applies to food found in any room, building, vehicle of transportation or other structure. The cost of condemning, destroying or rendering such food unsaleable shall be paid by the claimant.

63 Del. Laws, c. 148, § 1; 70 Del. Laws, c. 149, § 151; 70 Del. Laws, c. 186, § 1.;

(a) Whoever violates any of the provisions of § 3323 of this title shall, for each offense, be fined not more than $500, or imprisoned not more than 1 year, or both. For each subsequent offense, the violator shall be fined not more than $1,000 or imprisoned for more than 1 year, or both.

(b) When construing and enforcing § 3323 of this title, the act, admission or failure of any officer, agent or other person acting for or employed by any corporation, company, society or association, within the scope of employment or office, shall in every case be deemed to be the act, admission or failure of such corporation, company, society or association as well as of that person.

63 Del. Laws, c. 148, § 2; 70 Del. Laws, c. 186, § 1.;