June 13, 2016 by David Lennarz
Filed under: FDA News |
On June 9, 2016, the U.S. Customs and Border Protection (CBP) hosted a webinar on filing import entries through the Automated Commercial Environment (ACE) portal. The webinar was organized by the U.S. Food and Drug Administration (FDA) and the National Customs Brokers and Forwarders Association of America (NCBFAA).
What is ACE?
Customs brokers and self-filing importers must file information with CBP and other agencies regarding products they import into the United States. CBP describes ACE as “the primary system through which the trade community will report imports and exports and the government will determine admissibility.” CBP and FDA, along with 46 other government agencies, have partnered to make ACE a single window for submitting all data required by the agencies. ACE will replace ACS, the current commercial database used to submit data through CPB to FDA.
June 15, 2016 is the date when ACE is to become the sole filing system for the following FDA entry types:
- 01 – Consumption – Free and Dutiable
- 03 – Consumption – Antidumping/Countervailing Duty
- 06 – Consumption – Foreign Trade Zone (FTZ)
- 11 – Informal – Free and Dutiable
- 23 – Temporary Importation Bond (TIB)
- 51 – Defense Contract Administration Service Region (DCASR)
- 52 – Government – Dutiable
While June 15 acts as the mandatory filing date for these FDA entry types, CBP is allowing a sort of learning period through July 23, 2016. Entries filed through ACS after June 15 will likely be allowed, but the consequences will be decided on a case-by-case basis. Users may receive a warning message. CBP may also follow up with ACS filers to see why they are not filing through ACE and to determine how CBP can assist in the transition to ACE. Come July 23, ACS will no longer be allowed as an alternate filing method.
Common Errors when Filing in ACE
During the webinar, FDA revealed some of the most common errors and causes for entry rejection made when filing entries through ACE.
- Filers must provide a valid prior notice confirmation number for food and beverage shipments. Filers should only include the confirmation number and not the other FDA data required to file prior notice. Many filers submit invalid prior notice confirmation numbers.
- Many filers fail to provide a valid FDA registration number. (Tip: FDA requires food facilities to renew their FDA registration between October 1 and December 31 of each even-numbered year. Registrations not renewed as required are considered expired by FDA.)
- Many entries are rejected for a missing or invalid product code, affirmation of compliance code, or intended use code.
- Many filers include mismatching entity IDs. For example, an entry for a processed food must list a manufacturer code (as opposed to a grower code) as the entity ID.
- Many filers include mismatching source type codes. Entries for imports from growers or consolidators must list a country of growth, while entries for imports from manufacturers of processed foods must list a country of production. Both types of entries must also include a country of shipment.
- Many filers list a foreign country as the ultimate consignee for non-food items. This is incorrect, as the ultimate consignee is meant to represent the final destination where the product will be delivered within the United States.
These are but a few of the mistakes made when filing entries within ACE. FDA offers assistance with ACE entries at ACE_Support@fda.hhs.gov. FDA ACE support will be available 24/7 beginning sometime this month. FDA also provides this chart for identifying required data elements for entries of FDA-regualated products.
If you notice a mistake in an ACE entry, you may submit corrections up to 5 days before a shipment’s expected arrival to the United States. Once the shipment is within 5 days of its expected arrival, no corrections may be made unless FDA rejects the entry.
Speeding Up Your Imports
It’s prudent for brokers and importers to begin filing their entries through ACE as early as possible, as ACE provides the quickest entry. According to FDA, the agency is actively prioritizing ACE entries over those filed through ACS. Entries filed through ACE are processed two times faster.
While DUNS and FEI numbers are not currently required for filing entries of most commodities in ACE, FDA noted that including this data may expedite the processing of an entry. “Providing a DUNS number gives FDA a higher confidence level in looking at that data,” the agency said during the webinar regarding confirming the name and address of a product manufacturer.
How Registrar Corp can Assist
Registrar Corp offers a variety of services to help brokers obtain the information they need to file entries in ACE. Registrar Corp can:
Registrar Corp’s FDA Compliance Monitor also acts as a valuable resource for custom brokers and importers. The monitor provides detailed information on monitor facilities, such as a facility’s DUNS number (when available) and any FDA Warning Letters, Import Alerts, Import Refusals, and Inspection Classifications tied to the facility.
For more information on filing FDA-regulated entries in ACE, regulations for importing FDA-regulated products to the United States, or how Registrar Corp can assist, contact +1-757-224-0177. Live help is available 24-hours a day at www.registrarcorp.com/livehelp.
June 6, 2016 by David Lennarz
Filed under: Food & Beverages, FSMA |
On May 27, 2016, the U.S. Food and Drug Administration (FDA) published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major rules under FDA’s Food Safety Modernization Act (FSMA). The rule requires most food facilities that must register with FDA to develop and implement a written Food Defense Plan for human foods manufactured, processed, packed, or held at the facility. Food Defense Plan development can be broken into three steps:
Step 1: Vulnerability Assessment
Covered facilities must assess significant vulnerabilities for each actionable step that takes place at the facility (mixing, cooking, labeling, packaging, etc.), including:
- The potential impact on public health
- The degree of physical access to the product
- The ability to successfully contaminate the product
The assessment must be written and must include an explanation as to why each point, step, or procedure was or was not identified as an actionable process step. Assessments must consider the possibility of an inside attacker.
Step 2: Mitigation Strategy Development
Once a facility identifies the vulnerabilities associated with their food operations, it must identify and implement mitigation strategies to minimize or prevent those vulnerabilities. The Food Defense Plan must include written explanations for how each strategy will sufficiently mitigate the corresponding vulnerability. An example of a mitigation strategy would be placing numbered seals on a load before transportation. This would allow the recipient of the load to ensure the same seal was unbroken upon arrival, verifying that the load was not tampered with. Another example would be the use of locks to limit access to vulnerable areas within the facility.
Step 3: Maintenance
Covered facilities must monitor their mitigation strategies to ensure they are properly implemented. A facility’s Food Defense Plan must identify its monitoring procedures and how often they will occur. If monitoring reveals that a mitigation strategy was not properly implemented, facilities must take corrective actions. Facilities must also conduct verification activities to ensure that both monitoring and corrective actions, if necessary, are being conducted. Facilities must maintain records for food defense monitoring, corrective actions, and verification activities.
Required activities under FDA’s Intentional Adulteration rule must be conducted by one or more qualified individuals. The qualified individual(s) must:
- Prepare the Food Defense Plan
- Conduct the vulnerability assessment
- Identify and explain the mitigation strategies
- Conduct reanalyses of the Food Defense Plan (required at least once every three years)
FDA defines a qualified individual as “a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required under [this regulation], as appropriate to the individual’s assigned duties.” A qualified individual may be an employee of the facility or a third party.
Most covered facilities must comply with FDA’s Intentional Adulteration rule by May 27, 2019 (three years after publication of the final rule). Small businesses (defined as businesses with fewer than 500 full-time equivalent employees) have one additional year to comply.
Very small businesses are exempt from most requirements under FDA’s Intentional Adulteration rule. In order to take advantage of this exemption, businesses must provide records to FDA proving their very small business status by May 27, 2021 (five years after publication of the final rule). FDA defines a very small business as ” a business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale.”
There are a few exceptions to FDA’s Intentional Adulteration rule, such as the holding of food (except food held in liquid storage tanks), food for animals, and alcoholic beverages under certain conditions. View FDA’s final rule for a complete list of exemptions.
Registrar Corp is a U.S. FDA consulting firm that helps food facilities comply with FDA regulations, including new requirements under FSMA. Registrar Corp’s Food Safety Specialists can develop or review a Food Defense Plan for compliance with FDA’s Intentional Adulteration rule. For questions or assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
May 20, 2016 by David Lennarz
Filed under: Food & Beverages |
On May 20, 2016, the U.S. Food and Drug Administration (FDA) finalized two new rules that mandate significant changes to Nutrition Facts Labels for food and beverages. FDA’s goals of updating the Nutrition Facts Label include:
- Making it easier for consumers to make better informed food choices by emphasizing certain nutrition aspects, such as calories and serving sizes.
- Updating serving sizes to more realistically reflect U.S. food consumption.
- Reflecting updated scientific information, including the link between diet, chronic diseases, and public health.
The new Nutrition Facts Label format considerably increases the font size of the word “Calories” and the number of calories. The number of calories is also bolded. The number of calories from fat is removed from the label. According to FDA, “research shows the type of fat is more important than the amount.”
The font size of the words “servings per container” and the serving size declaration also feature an increase. The serving size declaration is bolded.
Along with emphasizing the serving size on the new Nutrition Facts Label, FDA’s rules create new requirements for determining the serving size of a product. By law, serving sizes must reflect the amount of food and beverages people truly consume rather than what they should consume. For example, before the rule, many 20 ounce bottles of soda were labeled as 2 servings despite the fact that the average U.S. consumer drinks an entire 20 ounce bottle at once. Now, 20 ounce sodas are required to be labeled as one serving. The same is true for other packages that were previously labeled as two servings but typically consumed in one sitting. FDA’s new rules update various other serving sizes as well. For example, the serving size of ice cream increased from ½ cup to 2/3 cup.
FDA’s new rules require certain products that may be consumed in either one or multiple sittings to bear a “dual column” label that identifies calorie information for both “per serving” and “per package/per unit”.
The new Nutrition Facts Label format differentiates “Added Sugars” from “Total Sugars”. According to FDA, “scientific data shows that it is difficult to meet nutrient needs while staying within calorie limits if you consume more than 10 percent of your total daily calories from added sugar.”
Nutrient Daily Values
FDA’s new rules add vitamin D and potassium to the required list of nutrients, while the inclusion of vitamins A and C were made optional. The rules update daily values for sodium, dietary fiber, and vitamin D based on new scientific evidence. The new Nutrition Facts Label lists the actual amount of vitamin D, calcium, iron, and potassium in addition to the percent Daily Value.
The new rules also update the percent Daily Value footnote to read “*The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”
FDA’s rules mandate minor changes to Supplements Facts Labels for dietary supplements as well to ensure consistency with Nutrition Facts Labels for food and beverages.
Most food manufacturers are required to use the new label by July 26, 2018. Manufacturers with less than $10 million in annual food sales have an additional year to comply.
It’s prudent for food facilities to begin redesigning their labeling now, as the process of designing, printing, and relabeling can take some time. Relabeling early will allow for a smooth and efficient transition from old to new labeling within the time allotted by FDA.
Registrar Corp’s Labeling and Ingredient Review Specialists can help food facilities update their labels to comply with FDA’s new rules. Along with updating a facility’s Nutrition Facts Label, Registrar Corp will review all aspects of a food’s labeling, including ensuring any claims made are within FDA’s boundaries to do so. For more information, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
May 19, 2016 by David Lennarz
Filed under: Food & Beverages |
Due to evolving nutrition research and a citizen petition filed by KIND LLC, the U.S. Food and Drug Administration (FDA) has decided it’s a good time to reevaluate its definition of the term “healthy”. The agency plans to gather public comment on use of the term “healthy,” along with other nutrient content claims, in the near future.
The decision was announced as part of a statement FDA published last week regarding KIND LLC’s use of the term “healthy” on its food labeling. FDA issued a warning letter to KIND in March 2015 due to KIND’s use of the term “healthy” on products that did not meet FDA’s criteria for labeling products as such. After evaluation of KIND’s corresponding corrective actions, FDA issued a closeout letter to KIND in April 2016. After KIND received its closeout letter, the company asked FDA if it could use the phrase “healthy and tasty” to present its corporate philosophy so long as the phrase:
- Isn’t represented as a nutrient content claim, and
- Is not placed on the same display panel as nutrient content claims or nutrition information.
FDA agreed to allow KIND to use the phrase under these circumstances.
FDA’s Current Definition of Healthy
Industry has taken issue with FDA’s current regulation of “healthy” because it rules out foods widely recognized as healthy and nutritious, such as almonds, salmon and avocados, due to high fat content.
FDA currently allows “healthy” and similar terms to be used as implied claims on food labeling if the food meets the following conditions:
Read more on KIND’s Citizen Petition for examples of suggestions the company gave to FDA for updating its regulations.
Reevaluating Use of the Term “Natural”
In a similar instance, FDA recently decided to reevaluate the use of the term “natural” on food labeling. There is currently no formal definition for the term natural, but FDA has received four citizen petitions on the matter since its decision not to regulate the term in 1991. FDA began accepting comments on use of the term “natural” in November 2015. The comment period closed on May 10, 2016. The New York Times reports that FDA is currently in the process of reviewing those comments, a process which could take months.
FDA’s food labeling regulations are strict and extensive, and understanding the requirements to make certain claims can be complicated. Registrar Corp’s Labeling and Ingredient Review Specialists can review food and beverage labeling for FDA compliance, including ensuring the product meets FDA requirements to make any claims listed. For more information, contact +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
May 11, 2016 by David Lennarz
Filed under: Uncategorized |
On May 10, 2016, the U.S. Food and Drug Administration (FDA) published a final rule (81 FR 28973) that extends the agency’s authority to all tobacco products, including (but not limited to) e-cigarettes, cigars, hookah tobacco, and pipe tobacco. The final rule becomes effective on August 8, 2016 (90 days from the date of publication).
FDA considers tobacco use to be a significant threat to public health. According to FDA, smoking is the leading cause of preventable disease and death in the United States. Under the final rule, newly-regulated tobacco products are subject to premarket review and authorization by FDA. Manufacturers of these newly-regulated tobacco products must register their establishments and list their products with FDA as well as place health warnings on product packages and advertisements. Manufacturers will not be able to market their tobacco products as modified risk (i.e., “light”, “low”, or “mild”) without FDA authorization. Manufacturers must also report ingredients and harmful and potentially harmful constituents to FDA.
Registration and Listing Requirements: Differences for Domestic and Foreign Manufacturers
The new registration and listing requirements will initially only apply to domestic tobacco manufacturers. Section 905 of the Food, Drug, and Cosmetic Act requires FDA to issue a rule through the notice and comment rulemaking process in order to apply the registration and product listing requirements to foreign manufacturers. FDA has announced its intent to issue a rule requiring registration and listing for foreign tobacco manufacturers in the Unified Agenda and expects to publish the proposed rule in September 2016.
Registrar Corp can assist tobacco manufacturers in registering and listing their products with FDA per the new requirements.
The Rule’s Effect on Youth Access to Tobacco Products
While the use of traditional cigarettes by minors has decreased, their use of other tobacco products has increased significantly. According to FDA, e-cigarette use among high school students rose from 1.5 percent in 2011 to 16 percent in 2015 (a 900 percent increase). A goal of FDA’s final rule is to protect youth from the dangers of tobacco via age-restrictions and restricting advertising that appeals to minors.
Before FDA finalized the rule, there were no federal regulations prohibiting the sale of e-cigarettes, hookah tobacco, or cigars to consumers under the age of 18. Under the new rule, these products can no longer be sold to minors, either in person or online. Sellers must verify the age of purchasers by photo identification. The rule also prohibits the distribution of free samples or selling covered tobacco products in vending machines (unless in an adult-only facility).
Registrar Corp is a U.S. FDA consulting firm that helps companies comply with FDA regulations. Registrar Corp can help tobacco product manufacturers determine how FDA’s new rule applies to their particular products. Registrar Corp can register manufacturers and list tobacco products with FDA as well as review tobacco product labels and advertisements to ensure compliance with FDA labeling regulations.
For more information, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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