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On April 10, 2015, the State of New York Office of the Attorney General issued a warning letter to Snap Infusion LLC regarding their product “SmartCandy.”  The letter expressed concern that SmartCandy may violate the U.S. Food and Drug Administration (FDA) fortification policy.  The FDA fortification policy states that FDA does not consider it appropriate to fortify sugars or snack foods such as candies because random fortification of foods could “result in over- or underfortification in consumer diets” and “result in deceptive or misleading claims for certain foods.”

SmartCandy, which was launched on February 3, 2015, is marketed as “a vitamin infused snack” and “an excellent source of vitamins A+B+C”.  The Attorney General warning letter states that “these claims can only be based on added vitamins, not the fruits prominently depicted on the SmartCandy packaging but absent from the list of ingredients.”

It will not be surprising if FDA joins the Attorney General in warning Snap Infusion LLC about its SmartCandy.  FDA has warned candy companies about violating its fortification policy in the past.  In 2011, FDA issued a warning letter to Goetze’s Candy Co., Inc. because the company claimed its Caramel Creams Double Chocolate was fortified with calcium.  In 2012, FDA issued a warning letter to The Hershey Company for marketing its Hershey’s Syrup + Calcium and Hershey’s Syrup Sugar Free with Vitamin & Mineral Fortification.  FDA gave Goetze’s and Hershey 15 days to respond to their warning letter with a plan to correct the violations and warned that failure to take prompt action could subject the companies to further regulatory action, including seizure and injunction.  Snap Infusion LLC would likely be subject to the same consequences.

FDA’s food labeling requirements are strict and extensive, so it’s prudent to have a specialist review a product’s labeling and promotional materials before marketing.  Registrar Corp can review food labels for FDA compliance, including nutrient and other claims made.  Registrar Corp Label and Ingredient Review Specialists scrutinize every element of a label and measure it up to the Code of Federal Regulations, warning letters, and other regulatory documents.  For assistance with FDA food labeling requirements, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at


Q&A: FDA Standard of Identity for Ice Cream

April 15, 2015 by David Lennarz

Registrar Corp often receives questions regarding U.S. Food and Drug Administration (FDA) regulations.  This week, we’re answering a question about FDA requirements for calling a product “ice cream.”

Question: Why does the FDA allow Ice Cream that has no cream in it, contains thickeners, emulsifiers and artificial processed ingredients to be called “Ice Cream”?  Margarine cannot be called butter, so how does fake ice cream get to be called “Ice Cream”?

Answer: FDA has “standards of identity” for certain food products.   Standards of identity set requirements for how a product must be manufactured and identify ingredients that a product can and cannot contain in order to be marketed under a certain name.

FDA has a standard of identity for ice cream (21 CFR 135.110).   According to the standard, cream is an optional dairy ingredient, so a product is not required to contain cream to be called ice cream.  The standard also allows for artificial ingredients to be used and may require that the name of the product reflect their presence.  Take vanilla, for example.  If an ice cream product contains all-natural vanilla, the name of the product can include being called “vanilla” on the label.  If the product contains both natural and artificial vanilla and the natural flavor is predominating, the product can be called “vanilla flavored.”  If the artificial flavor is predominating or is the only flavor present, the product must be called “artificial vanilla” or “artificially flavored vanilla.”

Not all food products have a standard of identity, but those that do include milk, cream, yogurt, sherbet, margarine, different types of cheeses and breads, and more.  Registrar Corp can help food manufacturers determine whether or not a specific product meets an FDA standard of identity, as well as review food labels for FDA compliance.  For assistance, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24-hours a day at


Labeling Food as Organic

April 7, 2015 by David Lennarz

According to the U.S. Department of Agriculture (USDA), consumer demand for organic food products is on the rise.  Studies have shown that the increased demand is due to health and environmental concerns, as well as concern for the humane treatment of animals.  The growing market makes labeling a product as organic an appealing option, but what are the regulations for doing so?  Can one simply add the word “organic” to a food label? The answer is no.

The USDA National Organic Program (NOP) regulates organic standards and claims for food.  According to USDA, “organic food is produced without using most conventional pesticides; fertilizers made with synthetic ingredients or sewage sludge; bioengineering; or ionizing radiation.” Organic food is also produced per the National List of Allowed and Prohibited Substances (National List). In order to be labeled as organic, a product generally must be certified organic by a USDA-accredited certifying agent.  Certifying agents can be found throughout the world, and will inspect a farm or facility to ensure products are grown and processed according to USDA NOP standards.

A product must be at least 95 percent organic to include the USDA organic seal on its label or to claim to be organic or “made with organic ingredients”.  The graph below demonstrates some of the other requirements for organic food labels.

Organic Chart

A person who labels a product “organic” when they know it does not meet USDA standards is subject to a fine of up to $11,000 for each violation.

Organic farms and businesses with a gross agricultural income from organic sales of less than $5,000 may label their products as organic without being certified.  However, they cannot use the USDA organic seal or refer to their products as “certified organic.”  Aside from the certification requirement, other USDA organic labeling requirements still apply.

Organic foods must comply with both USDA’s organic labeling regulations and the U.S. Food and Drug Administration’s (FDA) food labeling regulations.  Registrar Corp assists food facilities with U.S. FDA compliance. Registrar Corp’s Label and Ingredient Review Specialists can review and modify a food label for FDA compliance, as well as offer guidance regarding organic and other claims.  Clients receive a detailed report and a print-ready graphic file of their label that incorporates Registrar Corp’s suggested changes.

For questions regarding organic claims or assistance with a food label, contact Registrar Corp at +1-757-224-0177 or via 24-hour Live Help at


FDA Hosts Medical Device Reprocessing Webinar

March 27, 2015 by David Lennarz

On March 24, 2015, the U.S. Food and Drug Administration (FDA) offered a webinar to review the agency’s guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” that was published last week.  The webinar was presented by Elaine Mayhall from FDA’s Office of Device Evaluation and Geetha Jayan from FDA’s Office of the Center Director.  Mayhall and Jayan said the purpose of the guidance was to provide recommendations to device manufacturers for developing reprocessing instructions that can be easily understood and followed by users because proper reprocessing plays an important role in reducing the risk of patient infections from reusing devices.

Mayhall and Jayan said the recommendations in the guidance are applicable to four types of devices:

  1. Reusable devices that are initially supplied sterile to a user and require the user to reprocess the device after each patient use
  2. Reusable devices that are initially supplied non-sterile to a user and requiring the user to process the device prior to initial use, as well as after each use
  3. Reusable devices that are intended for reuse by a single patient and need to be reprocessed between each use
  4. Single-use devices that are initially supplied non-sterile and require a user to process the device prior to its use

These devices must be cleaned and then either sterilized or disinfected, depending on their contact with patients. The processes used to clean, sterilize, or disinfect a particular device must be validated by FDA.  Cleaning, disinfecting, and sterilization are distinctly different processes and require separate validation.  FDA recommends that device manufacturers consider reprocessing needs in the early stages of designing a device and use designs that make it easy for users to affectively implement the process.

The new guidance replaces FDA’s 1996 guidance titled “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities.”  The guidance was expanded to include information regarding the validation of reprocessing methods and instructions and provides greater clarity on documentation to be provided in different premarket submissions (510(k), PMA,  de novo, etc.).  Mayhall and Jayan said the guidance puts specific emphasis on the importance of proper cleaning, testing worst-case scenarios, and designing devices that are less challenging to reprocess.

Mayhall and Jayan discussed FDA’s six criteria for writing reprocessing instructions:

1. Instructions should reflect the intended use of the device.

What constitutes appropriate instructions depends on many factors, such as if the device has direct or indirect contact with patient, the design of device, the  intended use of the device, if any toxic chemicals were used on the device, etc.

2. Instructions should advise users to thoroughly clean the device.

Adequate sterilization and disinfection depend on a thorough cleaning.

3. Instructions should indicate the appropriate microbicidal process for the device.

The appropriate microbicidal process for a device depends on the device’s Spaulding Classification.  A device can be critical, semi-critical, or non-critical.  Critical devices are introduced directly into the blood stream or contact a normally sterile tissue or body-space during use.  Critical devices should be thoroughly cleaned and sterilized after each use.  Semi-critical devices contact mucous membranes or non-intact skin.  They usually do not penetrate tissues or enter normally sterile areas of the body.  Semi-critical devices should be thoroughly cleaned and sterilized.  If sterilization is not possible, semi-critical devices can undergo high-level disinfection.  Non-critical devices only contact intact skin and do not penetrate it.  Non-critical devices should be thoroughly cleaned and then undergo either intermediate or low level disinfection, depending on the contamination.

4. The instructions should be feasible and only include legally marketed devices and accessories

Device manufacturers should consider the location where the device is likely to be used.  Disinfection and sterilization methods need to be feasible for users to implement, and the equipment and accessories needed to implement the instructions should be readily available to users.  A manufacturer should not suggest something like radiation sterilization, as this is usually only available at a manufacturing facility and therefore would not be readily available to users.

5. Instructions should be comprehensive

Mayhall and Jayan said the instructions should help the user understand precisely how to conduct the entire reprocessing procedure safely and productively.  The instructions should be so simple and specific that a lay person or patient could do it in their home.  The instructions need to cover every detail. For example, if a user needs to rinse the device, the instructions should indicate the necessary water quality and temperature and how long to continue rinsing.   The instructions should describe how and when to disassemble a device and should list the cleaning agents or the class of cleaning agents to use.

The instructions should instruct the user to inspect the device after reprocessing and, if the device does not appear clean, to repeat the process or dispose of the device.  Mayhall and Jayan said the instructions should always include the manufacturer’s contact information.

6. Instructions should be understandable

Instructions should use simple language and should be clear, logical, sufficiently detailed, and written in sequential order.  Mayhall and Jayan suggested including charts, diagrams, and pictures.

FDA will review the reprocessing procedures and instructions for a device when it conducts the pre-market review for the device.  All cleaning, disinfection, and sterilization validations should be completed before the pre-market application is submitted.   Mayhall and Jayan identified particular documentation required for specific pre-market submissions:

PMA, HDE, and de novo: Protocols and complete test reports of validation of reprocessing instructions

510(k): Manufacturers of a subset of devices should include data to validate their reprocessing instructions.  Validation data may also be requested for substantial equivalence.

IDE: Summary of the validation of reprocessing instructions

Mayhall and Jayan ended the webinar with three key messages of the guidance:

  1. Reusable device labeling should include instructions for reprocessing and reusing devices and accessories safely
  2. All cleaning, disinfection, and sterilization processes should be validated
  3. Labeling should provide sufficiently detailed reprocessing instructions

Registrar Corp is a U.S. FDA consulting firm that helps medical device establishments comply with FDA regulations.  Our Regulatory Specialists can help device manufacturers determine whether or not FDA’s reprocessing guidance applies to their products, as well as review their device labels for FDA compliance.  For questions or assistance with FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or receive help from a Regulatory Advisor 24 hours a day at


The U.S. Food and Drug Administration (FDA) recently evaluated two types of Okanagan Specialty Fruits, Inc.’s genetically engineered apples and six types of J. R. Simplot Company’s genetically engineered potatoes. Okanagan reduced the levels of enzymes in its apples that cause browning associated with cuts and bruises.  J.R. Simplot reduced enzymes in its potatoes to help resist black bruise spots, as well as engineered the potatoes to produce less acrylamide, a chemical found to be carcinogenic in rodents.  On March 20, 2015, FDA announced that it had “concluded that these foods are as safe and nutritious as their conventional counterparts.”

Genetic engineering, also known as biotechnology, refers to methods used by scientists to modify the traits or characteristics of an organism.  According to FDA, genetically engineered plants have been part of our food supply since the 1990s. Genetically engineered food and food ingredients must comply with the same FDA regulations and safety standards as other food.  FDA offers a voluntary biotechnology consultation process to help manufacturers ensure their genetically modified foods are safe and compliant.  According to Dennis Keefe, director of FDA’s Office of Food Additive Safety, “the consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties.”

FDA has completed approximately 166 biotechnology consultations to date.  FDA has found that, when compared to foods derived from traditionally bred plants, genetically engineered foods are generally equally nutritious and do not pose a greater risk for allergic or toxic reactions.

Currently, there is no FDA requirement for food manufacturers to indicate whether food has been genetically engineered on product labels.  FDA is in the process of reviewing two citizen petitions requesting that the agency change its labeling requirements for genetically engineered foods.  For the time being, food manufacturers can voluntarily include this information on labels.

In 2001, FDA published a voluntary labeling guidance to assist manufacturers of genetically engineered food in determining what information is required and what information is optional.  The guidance states that under section 201(n) of the Food, Drug, and Cosmetic Act (FD&C Act), FDA requires food labels to disclose all material facts about the food and thus:

  • If a bioengineered food is significantly different from its traditional counterpart such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference.
  • If an issue exists for the food or a constituent of the food regarding how the food is used or consequences of its use, a statement must be made on the label to describe the issue.
  • If a bioengineered food has a significantly different nutritional property, its label must reflect the difference.
  • If a new food includes an allergen that consumers would not expect to be present based on the name of the food, the presence of that allergen must be disclosed on the label.

The guidance also helps manufacturers determine proper language for labeling their products as being genetically engineered as to not be misleading.  FDA has found that consumers prefer the term “biotechnology” over “genetic modification” or “genetic engineering”, and they prefer to know why genetic engineering was used on the product (increased nutrition, resistance to discoloration, etc.).  So, a preferable statement to identify a genetically engineered food could be: “This product contains corn developed using biotechnology to increase resistance to insects.”

FDA warns that the amount of a genetically engineered ingredient within a food item can determine whether a statement is misleading.  For example, FDA may consider it misleading to state that a food includes nutritionally improved soybeans if the soybeans make up only a small portion of the ingredients.

Registrar Corp helps food and beverage manufacturers comply with U.S. FDA regulations.  Registrar Corp’s Label and Ingredient Review Specialists can review food labels for FDA compliance, including identifying statements that could be considered misleading to consumers.  For assistance with labeling or any other FDA regulations for food and beverage companies, contact Registrar Corp at +1-757-224-0177 or speak to a Regulatory Advisor 24 hours a day at

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