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1) If caramel color is a conponent of a flavor ingredient, but adds no function to the total formula, does the caramel color need to be declared on the label?
2) What is the right interpretation of "Substances the use of which is permitted by regulations in this part" found in Section 175.300 (b)(3)? This article states that "Any substance employed in the production of resinous and polymeric coatings that is subject of a regulation in subchapter B of this chapter and conforms with any specification in such regulation." This suggests that the substance listed in Sec. 175.105 (Adhesives)are also applicable for coatings (175.300) notwithstanding the fact that the title of Subpart B says "Substances for use only as components of adhesives". Is this the right assumption or do I have to conclude that for coatings only the compositions/substances mentioned under 175.300 are approved?
3) Are there any regulations pertaining to packing for point of sale displays of customer provided bottled alcoholic beverages?
4) Is there a difference between the terms "FDA Compliant" and "FDA Approval" for a product?
5) Does USA law require that packages manufactured and filled in the USA be labeled with both metric and pounds indicating the package capacity?
6) I have read that the use of carbon monoxide in contact with food has been banned by the European Union. Having spent many hours trying to track down this elusive piece of legislation, can either provide me a copy of the relevant legislation or at least point me in the right direction? Also, I am confused by an apparent contradiction to this supposed legislation contained in the article found at http://www.eufic.org/page/en/faqid/what-is-modified-atmosphere-packaging-map/. Can you advise why this appears to give support to the use of carbon monoxide in contact with food under certain conditions if there is in fact legislation banning it's use?
7) For compliance with the FDA's indirect Food Additives, 21 CFR 174.5, do additives/raw materials that will be used to manufacture color concentrates in thermoplastics for use in food contact applications need to be manufactured using cGMP, or is the cGMP really for the manufacture of the packaging itself? For instance, a stearic acid is an ingredient in a color concentrate that will be used in the manufacture of a (177.1210) closures with sealing gaskets for food containers. The stearic acid is of a suitable purity but it has not been manufactured following the cGMP guidelines, can it still be used? It appears in 21 CFR 174.5 that the reference to good manufacturing practice is for the use of the additive, not for it's manufacture.
8) How would 21 CFR 211 impact a printer that prints supplied graphics on tubing received from another company? The printer does not create the graphic content or supply the material. After the printing is completed, the printer sends the materials, in rolls, back to the first company, for tube formation and filling for a third party.
9) What type of certification do you need to be included on China's "positive list" of 959 food additives that will be authorized for use in food packaging materials? Does this apply to biodegradable additives? Does the EU certification with REACH qualify a product in China as well?
10) Are SPI codes (chasing arrows) on packaging required anywhere in the U.S.?
11) There is an article on PackagingLaw.com about China publishing a positive list of approved substances for use in food packaging. Is there an FDA equivalent of this list?
12) Is the sale of liquid non-TSCA permitted material allowed if the dried film is FDA 175.300 compliant?
13) Are there legal or regulatory items that need to be considered concerning use of ethylene vinyl alcohol copolymer?
14) Is there a packaging regulation in California that requires, if you use artificial ingredients, it needs to be listed on the package in text that is no less than 50% of the product descriptor?
15) Is a special DMF required for packaging materials used to package Medical Devices or will a DMF set for packaging materials used for food and drug packaging suffice?
16) Is the use of the Oxo-Biodegradable logo on plastic bags allowed in California?
17) Why are gluten, barley, rye and, oats—which are harmful to individuals with Celiac Disease—not required to be listed as allergens on food packages?
18) Our product has two components; one is made in China and the other is made in the U.S. We realize that we have to disclose China, so can we simply state "Made in the U.S.A. and China"?
19) Are there any legal requirement on product's degree of filling in a package, or maximum headspace allowed within a package in either the EU or U.S.?
20) I am aware of the cooking temperature disclaimer on packaging: Recommended serving temperature for meat and vegetables is 165o F. Can the word "meat" be swapped out and "protein" used instead? This disclaimer is on a complete frozen meal package. I was asked to use "protein" instead of "meat" in the disclaimer statement.
21) I have a body shaper garment with a sewn-in garment label that includes washing instructions printed on it, and I am using a box to package the product. Am I required by law to include the washing instructions on the box?
22) Is specific wording required on suffocation warning labels on plastic bags, such as "WARNING: This bag is not a toy. Please dispose of properly. To avoid danger of suffocation, keep bag away from babies and children. Do not use bag in cribs, beds, carriages or playpens."?
23) We have vacuum accessory products that we sometimes make here in the states, and sometimes we purchase in China. Can we mark the package "Made in USA or China"?
24) We distribute polymers in North America. One such polymer is Polybutadiene for impact modification of HIPS for packaging. In the past we have only had to varify that the stabilizer in the polymer was FDA approved. Our HIPS customer is now telling us that we need to get "Health Canada" approval for the polymer. Can you provide any guidance on this process?
25) In case of hard boiled confectionery wrapping, is it mandatory to use a inner strip of wax paper or foil in conjunction with the reverse printed twist wrap film? If a user fails to use the inner strip and, as a result, the ink get transferred to the confectionery, does this amount to the fact that the outer wrapper in faulty?
26) We are a specialty display packaging company. Is registration under the food bioterrorism statute required for a facility that receives a finished food product (i.e., canned peas), puts it in display boxes (without opening the cans or in any way altering them), and ships the newly boxed cans to the final customer?
27) Unlike foods and beverages, cosmetics' ingredients declarations include Latin and sometime French names for botanicals. Is this required by code of law?
28) What FDA regulations are applicable for polybutadiene rubber as a component of polystyrene food containers?
29) Why does Title 21 of the CFR database on the U.S. Food and Drug Administration's webpage state, "Revised April 1, 2008" for each chapter and subsection? Also, the GPO website also has April 1 revision dates listed for 21 CFR. We are having some problems explaining to our European co-workers that this doesn't mean that 21 CFR is updated (changed) each year.
30) I have been seeing various baby food bottles being labeled as BPA free under public pressure to remove BPA. I am assuming that no part of that package contains BPA. If metal food containers are forced down a similar BPA free path, would that require all portions of the package (exterior coatings, tabs, varnished, etc) to also carry the BPA free tag?
31) a. I am a manufacturer of outdoor power equipment. Some of our manuals and small parts ship in plastic bags. We ship worldwide; it appears both Canada and Europe are primarily interested in suffocation warnings on bags for toys. Do any of the states or cities in the US that require suffocation warnings on plastic bags require such warnings on bags for non-toy equipment?
b. Is there a minimum size below which the suffocation advisory is not needed on plastic bags?
32) a. We pack products in plastic pouches that we intend to ship to Canada. If the pouch is thicker than 1/1000 inch, then does it NOT require a suffocation warning?
b. We are starting a new distribution company in Canada and understand that a warning in both English and French about suffocation needs to be put on plastic bags. As a plastic bag distribution company, is it our responsibility to print the warning for our retailer customers or is it the retailer's responsibility?
33) If we produce a microwavable pouch, are there any regulations in the U.S. or Europe that we need to follow?
34) a. Are there any FDA regulations that specifically deal with food packaging and microwave use? We are seeing more customers wanting a letter stating that the packaging is safe for microwave use.
b. Which plastics are considered "microwave safe"?
35) We are producing a new produce packaging product that will compete against incumbent products from Europe. These products contain a barium-based red colorant that is not on any FDA compliant lists, it doesn't appear to have an FCN or be on the TOR list. But, the products have been sold in the U.S. for produce packaging for over 5 years. What would we need to do to use this same colorant on our product that will be made and sold in the US?
36) What is the rule for labeling net weight contents on a package? Is there a minimum weight that we can package a product? Specifically, the product is frozen desert cake.
37) Are there any regulations pertaining to adding a blinking light, mostly to call attention to a feature of the product, in a package?
38) We're having trouble finding information on whether an RN number is required on a packaging insert card (i.e., the company's card that is inserted into the vinyl zipper bag). Our understanding of FTC regulations is that an RN number is required on the FTC label but not on the insert card. Is there website where I can research this?
39) In the skin care industry, an 'e' is sometimes used on a weight claim on a folding carton or container, such as 4.0 Fl. Oz. e 120 ml. What is the purpose of this 'e' and when should it be used?
40) I am trying to find out when it is necessary to print a warning label on a garbage bag itself. We currently have a warning label on the packaging but not sure if it is required on the bag. Some garbage have a warning and some don't. Manufacturing is done in NJ and the product is sold nationally.
41) Can food packaging just have a phone number or does it also have to have a complete address? What are the specific requirements?
42) With regards to non-food consumer packaged goods, is there an EU law stating a minimum font size to be used on the packaging when it is referencing the product's warnings?
43) I have looked at the general guidelines for use of resin codes on plastic containers that can be recycled, both from the FTC and the SPI (Society of the Plastics Industry), and while they are fairly clear as "guidelines" in stating that the resin code in the 3-arrow recycling symbol should be placed on the bottom of the plastic container, are there any legal reasons that that same code and symbol cannot be placed on the face of the container instead?
44) We are manufacturing air freshener products in Thailand for sale directly to US retail stores. Is it permissible for us to use our Thailand Company name and address as the identity noted on the packaging, or must a US company (possibly the store) be identified? CFR 16.500.5 seems to apply only to U.S. companies.
45) Does a grocery bag qualify as indirect food contact and therefore make it necessary to comply with the related FDA regulations?
46) We are a tea bag packaging company and buy tea bag filter paper for packing tea bags. What are requirements for testing and analysizing filter paper as food contact materials?
47) Is there any mandatory terminology that needs to be displayed on a product sampling package of a non-food item?
48) We are using HDPE and Polypropylene Bottles for lotions. Is it necessary to conduct MVTR Test as per USP 671 for Liquids and Semisolids?
49) In order to claim that your use of a substance complies with 21 CFR 170.39, Threshold of Regulation for Substances Used in food contact articles, do you need to submit a petition to the FDA?
50) My question is regarding paper baking cups, the items inserted into baking trays when baking cupcakes. Are they regulated under the California Proposition 65 regulations on lead content or FDA regulations, similar to food wrappers, since this is a food contact item. Can you offer any insight into which regulation should be followed for paper baking cups?
51) Is there a monograph in the European Pharmacopeia that covers colorants used in the manufacture of rigid plastic containers to contain pharmaceuticals?
52) I am the Engineering Manager for a company specializing in food equipment design. Is there mutual recognition between Japan and the European Community and the USA in relation to conformity of materials intended to come into contact with foodstuffs? For example, does Japan recognize FDA or NSF approval for specific materials?
53) In 16 CFR Part 500 it outlines the requirements for net quantity content labeling of product contained in a package. My question pertains to products that are contained in flexible tube type packages. For example, if the product labeling states the package contains 3 oz of product should the target fill level be 3 oz, or 3 oz plus an amount of product that the consumer cannot express from the tube? There is always some product that is contained in the tube head, or just below the head, that the consumer cannot get out of the tube. Does this small amount of product need to be accounted for? Is there any formal guidance available?
54) Regarding extractives compliance testing (end tests), when we change the manufacturer of a multilayer plastic container using the same materials and the same specifications, are extractives (end tests) required on the finished container made at the new manufacturer?
55) I am the Package Design Manager for a consumer products company specializing in crafts products. I am looking for laws or regulations detailing what warning labels must be placed on the plastic bags in which our products are packaged.
Specifically I would like to know if these two warnings may be combined into one: "Choking Hazard-Small parts. Not for children under 3 years" and "WARNING: This bag is not a toy. Please dispose of properly. To avoid danger of suffocation, keep bag away from babies and children. Do not use bag in cribs, beds, carriages or playpens."
56) Are co-packers required to cook barbecue sauce at a certain temperature regulated by the FDA to ensure shelf life is certain? If so, what temperature is required? Also, what is the lowest temperature a barbecue sauce can cooked at and still maintain shelf life according to the FDA?
57) Do the FDA's food contact substance (FCS) regulations apply to a product that is sold separate of food and is not intended to be used with any particular food type or exclusively for food storage? An example is a food storage bag with a zip lock-type closure that would be marketed for food storage but may also have other applications.
58) Must all packaging containing products for retail sale display a physical address and phone number along with the company name, or will just a website address suffice? This is pertaining in particular to a packaged gift item, no food products included.
59) a. How does the "slack law" pertain to packaging in pouches?
b. What are the current laws or regulations that govern changes in package sizes in relationship to the price or weight?
60) a. We have been told by a customer that PVC packaging will be banned in California. I can find no such reference provided that the packaging conforms with existing RoHS rules. Can you confirm for me that laws in California, the U.S., and the EU do not ban PVC packaging per se?
b. What is the ruling on using PVC bottles for a consumer product? I understand that some states, such as California and Washington, have banned the use of PVC. Can you tell me if this is true and what states have this regulation?
61) California Prop 65 NSRLs and MADLs are stated in terms of exposure levels (µg/day) but suppliers of raw materials (resins, inks, etc.) used in manufacturing plastic goods use concentration levels (ppm) when responding to inquiries concerning substances controlled by Prop 65. A telephone conversation and email exchange with a representative of the Cal EPA resulted in little more than confirmation of the above discrepancy. Thus, letters from raw material suppliers that refer to a ppm level cannot be translated into an equivalent µg/day that does or does not require a warning notice. Of course, any such translation would require certain assumptions concerning the sum of exposures of a theoretical subject person but California provides no equation or table for this purpose. Question: In light of the above, how can a manufacturer of finished plastic goods safely respond to requests from its customers for written assurances that the finished goods do not require a warning under Prop 65?
62) I have seen several e-mails regarding the packaging and labeling of skin care products but still have a more specific question. Is there a regulation on the extent to which packaging materials should be cleaned (i.e., sterilized or sanitized before use/packaging). I am planning on making and selling skin-care products at home and want to make sure there are no laws governing how packaging materials are cleaned and sanitized before use. Moreover, does the package with skin care contents need to be safety-sealed?
63) Is it legal for a company to sell a PET plastic product with the intent that consumers reuse it repeatedly over a course of years? It is my understanding that #1 plastics are only recommended for food contact for single use, and that further use runs the increased risk of leaching DEHP into the contents.
64) I am writing from the Korean Small Business Corporation U.S. office, a government agency that promotes exports from small manufacturers in South Korea. A manufacturer of food packaging machines in Korea has an order from a U.S. company for one of its machines that uses some kind of fiberglass element in the sealing process. The question is if there might be FDA, USDA and/or EPA restrictions on importing a food packaging machine that has this kind of element. What is the process for importing the machine if these restrictions exist?
65) We are installing a automated powder filling machine for our protein drink. We are trying to set the tolerances. If the label says we have 450 grams of product, how much under and over can we be and still be within FDC or FDA regulations?
66) The FDA in November 2006 published a guidance document "Lead in Candy Likely to be Consumed by Small Children: Recommended Maximum Level and Enforcement Policy". This proposes that 0.1 ppm be the maximum level for candy and related food items. How does this correlate with the 100 ppm maximum level that CONEG (TPCH) model legislation states?
67) Does the label on the primary and secondary pack of a Class I or II device need to comply with the OTC regulation when the device is always recommended (not necessarily prescribed) to the user by a medical professional?
68) Are there any current requirements for tamper evident features on packages for oral solutions or for oral solids in clinical studies? Does the requirement differ if the study will be done at hospital/clinical study center or if the study will be done at home? The only document we can found concerning tamper evident is 21 CFR 211.132 but this is only valid for OTC products.
69) What are the EU and FDA rules pertaining to packaging food in UV coated board? Also, are there any advantages in using water-based coatings instead of UV-based coatings on board for use in food packaging?
70) Can you clarify the impact of REACH regulations on non-European manufacturers of packaging materials exported to the EU? We've invested some time in studying this but have yet to reach an understanding precisely what impact REACH will have on us in terms of documentation. I've also seen a BBC article claiming that packaging materials are exempt from REACH. At the same time numerous professional organizations are holding seminars to aid packaging manufacturers in dealing with the new legislation. Where does the truth lie?
71) We make disposable plastic products that are used in contact with food. We comply to FDA CFR 110. Do our raw material suppliers of plastic resins and colorants have to comply with 21 CFR 110 or 21 CFR 174.5 or both?
72) If a product is manufactured using an FDA approved resin and FDA approved colorant does essentially mean that the resulting manufactured product is FDA approved ?
73) What is the permissible limit of lead content in food packagings (like paperboard) having direct food contact?
74) a. We make a candle in the US. The glass container comes from China. The wax, fragrance, oil, label, and wick are made in the U.S. Since the glass is the only component from China, is it permissible to pull the made in china sticker off the glass?
b. We manufacture a promotional piece with three components. One component of is supplied to us from China. Our product is then added to another printed piece that is manufactured in the U.S. This is a non-food product. Do we need print "Made in China" or any notification that a component was made in China?
75) When an animal food is manufactured for a company by another company in a different location, must this be disclosed, as in "Manufactured for XYZ"?
76) Does labeling for a Prescription Medical Devices have to meet the regulations for OTC medical device labeling (21CFR801.61, 21CFR801.62, 21CFR801.15)? If not, what are the minimum requirements for labeling content and presentation (placement, font size) for Rx only devices?
77) What FDA regulations are applicable to sealers and finishes for countertops?
78) Is it acceptable to sell product with English only on the packaging in Ontario?
79) We make closures for the tooth paste industry. We have a DMF number in our USA plant but we want to supply the same product from our Mexican Plant.
Do I need to register another DMF number?
80) Is it required to label a photo of our product as "serving suggestion" on the PDP? What are the rules governing this?
81) When repackaging OTC vitamins/supplements, do they have to be in a childproof container?
82) What are the regulations for labeling Personnal Care products with the words natural, organic, or/and biodegradable?
83) We are importing a number of products manufactured offshore for re-sale in the U.S. Some of them are quite small and irregular shaped, and are packed in plastic bags, making labeling difficult. Is a small sticker on the label with just "China", "Taiwan", "Korea", etc. sufficient to serve as manufacturing source, or is the full "Made in China", "Made in Taiwan", "Made in Korea", etc. required?
84) Is there a requirement for non-food items (specifically steel uniform lockers) made in China to have a label of origin? Does it have to be displayed on the item, or only on the packaging? How prominently?
85) What paths do we have to take to get FDA compliance for an inorganic additive that we intend to add to fibre packaging and plastic packaging, e.g. it would be an "indirect food additive." My understanding for plastic packaging is if it is not listed under 21 CFR we would have to go down the path of FCN/FAP unless it is classified as "exempted from evaluation." The way it is exempt from evaluation is if we can prove it does not migrate into food via the FCN migration techniques (chemistry section). Is the above approch correct for plastics? What about fibre/paper?
86) Are there any detail requirments about the suffocation warning on polybag packing products sold in the European market? Does evey poly bag require a warning? Or, does it depend on the opening size or other criteria?
87) I'm trying to establish if there's any legislation governing the use of the word "new" on the label of a product going into the UK. I'm led to believe there might be a limited period after the launch of the new product that the term can be used on the packaging. Is this correct and, if so, what is the time period?
88) What if any are the FDA specifications or regulations for containers that hold alcohol, mostly for plastic bottling?
89) What is the law regarding listing ingredients on hair products? Can they just be listed on the outside box or must they be placed on the jar as well? If the consumer discards the box, there is no reference to the ingredients in case of an emergency, such as accidental ingestion. Also, what if the product is imported?
90) If a products package is clearly marked with "Made in China" is it necessary to also mark the product within the package? My question is concerning hardline products (not food) where the packaging mentioned is seen by the ultimate consumer at retail.
91) Is there currently a ban on PVC packaging material in the European Community?
92) Regarding French food contact safety regulations, was decree N°92-631 replaced by DGCCRF 2004-64? Do they have the same legal status?
93) We manufacture several organic compounds that are blended with pigments to make colorants for use in food packaging. Are our products affected by the 'French Positive List'? Where can this list be found?
94) In our factory in Europe we work with a plastic additive that it is been approved by European Community but it has not been approved by FDA. What will happen if we export this additive to the U.S. or South America?
95) If an food contact article which substrate material is FULLY covered by color coating (paint). (1) Is this coating regarded as "polymeric coating" under FDA 175.300? (2)Then, should the substrate material also comply with corresponding requirement (e.g., if the substrate is PP, then, should it comply the requirement of 177.1520?)?
96) Which European directive is similar to U.S. FDA 21 CFR 175.105 Indirect Food Additives - adhesives?
